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aclidinium | COPD | hives , itching, rash; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat. Aclidinium may cause serious side effects. Call your doctor at once if you have: wheezing, choking, or other breathing problems after using this medication; blurred vision, nausea , vomiting , eye pain or redness, or seeing halos or bright colors around lights; increased urination, painful or difficult urination; little or no urinating; or worsening or no improvement in your symptoms. Common side effects of aclidinium may include: stuffy nose, sore throat , sinus pain; cough; or headache . | aclidinium | Anticholinergic bronchodilators | Tudorza Pressair | 6% | Rx | C | N | COPD Other names: Bronchitis with Airway Obstruction; Bronchitis, Chronic; Chronic Bronchitis; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; Emphysema A group of lung diseases characterized by limited airflow with variable degrees of air sack enlargement and lung tissue destruction. Emphysema and chronic bronchitis are the most common forms of chronic obstructive pulmonary disease. | 9 | 14 | https://www.drugs.com/mtm/aclidinium.html | https://www.drugs.com/condition/chronic-obstructive-pulmonary-disease.html | ||
roflumilast | COPD | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , depression, trouble sleeping, or if you feel impulsive, or you have thoughts about suicide or hurting yourself. Call your doctor at once if you have rapid and unintended weight loss. rapid and unintended weight loss; tremors; pain or burning when you urinate; Common side effects of roflumilast may include: nausea , diarrhea ; loss of appetite, minor weight loss; headache , dizziness ; occasional sleep problems; back pain ; or flu symptoms. | roflumilast | Selective phosphodiesterase-4 inhibitors | Daliresp | 5% | Rx | C | N | COPD Other names: Bronchitis with Airway Obstruction; Bronchitis, Chronic; Chronic Bronchitis; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; Emphysema A group of lung diseases characterized by limited airflow with variable degrees of air sack enlargement and lung tissue destruction. Emphysema and chronic bronchitis are the most common forms of chronic obstructive pulmonary disease. | 7.8 | 48 | https://www.drugs.com/mtm/roflumilast.html | https://www.drugs.com/condition/chronic-obstructive-pulmonary-disease.html | ||
umeclidinium / vilanterol | COPD | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Umeclidinium and vilanterol may cause serious side effects. Call your doctor at once if you have: wheezing, choking, or other breathing problems after using umeclidinium and vilanterol; painful or difficult urination, or urinating more often; blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights; high blood sugar--increased thirst or urination, hunger, dry mouth, fruity breath odor; or low potassium level--leg cramps, constipation , irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling. Common side effects of umeclidinium and vilanterol may include: stuffy nose, sinus pain, sore throat ; chest pain, cough; diarrhea , constipation; muscle spasms; or pain in your neck, arms, or legs. | umeclidinium and vilanterol | Bronchodilator combinations | Anoro Ellipta | 5% | Rx | C | N | COPD Other names: Bronchitis with Airway Obstruction; Bronchitis, Chronic; Chronic Bronchitis; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; Emphysema A group of lung diseases characterized by limited airflow with variable degrees of air sack enlargement and lung tissue destruction. Emphysema and chronic bronchitis are the most common forms of chronic obstructive pulmonary disease. | 6.8 | 57 | https://www.drugs.com/mtm/umeclidinium-and-vilanterol.html | https://www.drugs.com/condition/chronic-obstructive-pulmonary-disease.html | ||
Bevespi Aerosphere | COPD | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: tremors, nervousness, chest pain, fast or pounding heartbeats; wheezing, choking, or other breathing problems after using this medicine; painful or difficult urination; blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights; high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or low potassium level - leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling. Common Bevespi side effects may include: cough; or urination problems. | formoterol and glycopyrrolate | Bronchodilator combinations | 4% | Rx | N | X | COPD Other names: Bronchitis with Airway Obstruction; Bronchitis, Chronic; Chronic Bronchitis; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; Emphysema A group of lung diseases characterized by limited airflow with variable degrees of air sack enlargement and lung tissue destruction. Emphysema and chronic bronchitis are the most common forms of chronic obstructive pulmonary disease. | 7.5 | 5 | https://www.drugs.com/bevespi-aerosphere.html | https://www.drugs.com/condition/chronic-obstructive-pulmonary-disease.html | |||
olodaterol / tiotropium | COPD | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Olodaterol and tiotropium may cause serious side effects. Call your doctor at once if you have: pounding heartbeats or fluttering in your chest; wheezing, choking, or other breathing problems after using this medicine; painful or difficult urination, or urinating more often; blurred vision, tunnel vision, eye pain , or seeing halos around lights; high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor; or low potassium level--leg cramps, constipation , irregular heartbeats, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling. Common side effects of olodaterol and tiotropium may include: runny nose ; cough; or back pain . | olodaterol and tiotropium | Bronchodilator combinations | 3% | Rx | C | N | Trelegy Ellipta: https://www.drugs.com/trelegy-ellipta.html | prednisone: https://www.drugs.com/prednisone.html | Symbicort: https://www.drugs.com/symbicort.html | Ventolin: https://www.drugs.com/cons/ventolin.html | Breo Ellipta: https://www.drugs.com/breo-ellipta.html | Spiriva: https://www.drugs.com/spiriva.html | Ventolin HFA: https://www.drugs.com/ventolin.html | Xopenex: https://www.drugs.com/xopenex.html | Anoro Ellipta: https://www.drugs.com/anoro-ellipta.html | Stiolto Respimat: https://www.drugs.com/stiolto-respimat.html | COPD Other names: Bronchitis with Airway Obstruction; Bronchitis, Chronic; Chronic Bronchitis; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; Emphysema A group of lung diseases characterized by limited airflow with variable degrees of air sack enlargement and lung tissue destruction. Emphysema and chronic bronchitis are the most common forms of chronic obstructive pulmonary disease. | 6.1 | 33 | https://www.drugs.com/mtm/olodaterol-and-tiotropium.html | https://www.drugs.com/condition/chronic-obstructive-pulmonary-disease.html | ||
Striverdi Respimat | COPD | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: tremors, nervousness, chest pain, fast or pounding heartbeats; wheezing, choking, or other breathing problems after using this medicine; worsening breathing problems; high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or low potassium level - leg cramps, constipation , irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling. Common Striverdi Respimat side effects may include: cold symptoms such as stuffy nose, sneezing, sore throat ; cough, shortness of breath, chest discomfort; diarrhea ; dizziness ; pain or burning when you urinate; back pain , joint pain; or rash. | olodaterol (inhalation) | Adrenergic bronchodilators | 3% | Rx | C | N | Trelegy Ellipta: https://www.drugs.com/trelegy-ellipta.html | prednisone: https://www.drugs.com/prednisone.html | Symbicort: https://www.drugs.com/symbicort.html | Ventolin: https://www.drugs.com/cons/ventolin.html | Breo Ellipta: https://www.drugs.com/breo-ellipta.html | Spiriva: https://www.drugs.com/spiriva.html | Ventolin HFA: https://www.drugs.com/ventolin.html | Xopenex: https://www.drugs.com/xopenex.html | Anoro Ellipta: https://www.drugs.com/anoro-ellipta.html | Stiolto Respimat: https://www.drugs.com/stiolto-respimat.html | COPD Other names: Bronchitis with Airway Obstruction; Bronchitis, Chronic; Chronic Bronchitis; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; Emphysema A group of lung diseases characterized by limited airflow with variable degrees of air sack enlargement and lung tissue destruction. Emphysema and chronic bronchitis are the most common forms of chronic obstructive pulmonary disease. | 5.5 | 4 | https://www.drugs.com/striverdi-respimat.html | https://www.drugs.com/condition/chronic-obstructive-pulmonary-disease.html | ||
olodaterol | COPD | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Olodaterol may cause serious side effects. Call your doctor at once if you have: tremors, nervousness, chest pain, fast or pounding heartbeats; wheezing, choking, or other breathing problems after using this medicine; worsening breathing problems; high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or low potassium level--leg cramps, constipation , irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling. Common side effects of olodaterol may include: cold symptoms such as stuffy nose, sneezing, sore throat ; cough, shortness of breath, chest discomfort; diarrhea ; dizziness ; pain or burning when you urinate; back pain , joint pain; or rash. | olodaterol (inhalation) | Adrenergic bronchodilators | Striverdi Respimat | 1% | Rx | C | N | Trelegy Ellipta: https://www.drugs.com/trelegy-ellipta.html | prednisone: https://www.drugs.com/prednisone.html | Symbicort: https://www.drugs.com/symbicort.html | Ventolin: https://www.drugs.com/cons/ventolin.html | Breo Ellipta: https://www.drugs.com/breo-ellipta.html | Spiriva: https://www.drugs.com/spiriva.html | Ventolin HFA: https://www.drugs.com/ventolin.html | Xopenex: https://www.drugs.com/xopenex.html | Anoro Ellipta: https://www.drugs.com/anoro-ellipta.html | Stiolto Respimat: https://www.drugs.com/stiolto-respimat.html | COPD Other names: Bronchitis with Airway Obstruction; Bronchitis, Chronic; Chronic Bronchitis; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; Emphysema A group of lung diseases characterized by limited airflow with variable degrees of air sack enlargement and lung tissue destruction. Emphysema and chronic bronchitis are the most common forms of chronic obstructive pulmonary disease. | 5.5 | 4 | https://www.drugs.com/mtm/olodaterol-inhalation.html | https://www.drugs.com/condition/chronic-obstructive-pulmonary-disease.html | |
revefenacin | COPD | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Revefenacin may cause serious side effects. Call your doctor at once if you have: wheezing, choking, or other breathing problems after using revefenacin; blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights; painful or difficult urination; or trouble emptying your bladder (a weak stream of urine). Common side effects of revefenacin may include: headache ; back pain ; or cold symptoms such as runny nose , stuffy nose, sneezing, cough, sore throat . | revefenacin (inhalation) | Anticholinergic bronchodilators | Yupelri | 1% | Rx | N | COPD Other names: Bronchitis with Airway Obstruction; Bronchitis, Chronic; Chronic Bronchitis; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; Emphysema A group of lung diseases characterized by limited airflow with variable degrees of air sack enlargement and lung tissue destruction. Emphysema and chronic bronchitis are the most common forms of chronic obstructive pulmonary disease. | 10 | 2 | https://www.drugs.com/mtm/revefenacin-inhalation.html | https://www.drugs.com/condition/chronic-obstructive-pulmonary-disease.html | |||
umeclidinium | COPD | hives , rash, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat. Umeclidinium may cause serious side effects. Call your doctor at once if you have: wheezing, choking, or other breathing problems after using umeclidinium; blurred vision, nausea , vomiting , eye pain or redness, or seeing halos or bright colors around lights; or painful or difficult urination, or urinating more often. Common side effects of umeclidinium may include: cold symptoms such as stuffy nose, sneezing, sore throat , cough; fast or irregular heartbeats; bruising, darkened skin; mouth pain, tooth pain ; muscle or joint pain; stomach pain; or altered sense of taste. | umeclidinium | Anticholinergic bronchodilators | Incruse Ellipta | 1% | Rx | C | N | Trelegy Ellipta: https://www.drugs.com/trelegy-ellipta.html | prednisone: https://www.drugs.com/prednisone.html | Symbicort: https://www.drugs.com/symbicort.html | Ventolin: https://www.drugs.com/cons/ventolin.html | Breo Ellipta: https://www.drugs.com/breo-ellipta.html | Spiriva: https://www.drugs.com/spiriva.html | Ventolin HFA: https://www.drugs.com/ventolin.html | Xopenex: https://www.drugs.com/xopenex.html | Anoro Ellipta: https://www.drugs.com/anoro-ellipta.html | Stiolto Respimat: https://www.drugs.com/stiolto-respimat.html | COPD Other names: Bronchitis with Airway Obstruction; Bronchitis, Chronic; Chronic Bronchitis; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; Emphysema A group of lung diseases characterized by limited airflow with variable degrees of air sack enlargement and lung tissue destruction. Emphysema and chronic bronchitis are the most common forms of chronic obstructive pulmonary disease. | 2.8 | 21 | https://www.drugs.com/mtm/umeclidinium.html | https://www.drugs.com/condition/chronic-obstructive-pulmonary-disease.html | |
Yupelri | COPD | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: wheezing, choking, or other breathing problems after using this medicine; blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights; painful or difficult urination; or trouble emptying your bladder (a weak stream of urine). Common Yupelri side effects may include: headache ; back pain ; or cold symptoms such as runny nose, sneezing, cough, sore throat . | revefenacin (inhalation) | Anticholinergic bronchodilators | 1% | Rx | N | COPD Other names: Bronchitis with Airway Obstruction; Bronchitis, Chronic; Chronic Bronchitis; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; Emphysema A group of lung diseases characterized by limited airflow with variable degrees of air sack enlargement and lung tissue destruction. Emphysema and chronic bronchitis are the most common forms of chronic obstructive pulmonary disease. | 10 | 2 | https://www.drugs.com/yupelri.html | https://www.drugs.com/condition/chronic-obstructive-pulmonary-disease.html | ||||
aclidinium / formoterol | COPD | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Aclidinium and formoterol may cause serious side effects. Call your doctor at once if you have: wheezing, choking, or other breathing problems after using aclidinium and formoterol; worsening breathing problems; tremors, nervousness , chest pain, fast or pounding heartbeats; severe headache, pounding in your neck or ears; painful or difficult urination, or urinating more often; blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights; high blood sugar--increased thirst or urination, hunger, dry mouth, fruity breath odor; or low potassium level--leg cramps, constipation , irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling. Common side effects of aclidinium and formoterol may include: headache; back pain ; or cold symptoms such as stuffy nose, sneezing, sore throat . | aclidinium and formoterol | Bronchodilator combinations | Duaklir Pressair | 0% | Rx | N | COPD Other names: Bronchitis with Airway Obstruction; Bronchitis, Chronic; Chronic Bronchitis; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; Emphysema A group of lung diseases characterized by limited airflow with variable degrees of air sack enlargement and lung tissue destruction. Emphysema and chronic bronchitis are the most common forms of chronic obstructive pulmonary disease. | null | null | https://www.drugs.com/mtm/aclidinium-and-formoterol.html | https://www.drugs.com/condition/chronic-obstructive-pulmonary-disease.html | |||
Breyna | COPD | null | budesonide and formoterol fumarate | Bronchodilator combinations | 0% | Rx | C | N | Trelegy Ellipta: https://www.drugs.com/trelegy-ellipta.html | prednisone: https://www.drugs.com/prednisone.html | Symbicort: https://www.drugs.com/symbicort.html | Ventolin: https://www.drugs.com/cons/ventolin.html | Breo Ellipta: https://www.drugs.com/breo-ellipta.html | Spiriva: https://www.drugs.com/spiriva.html | Ventolin HFA: https://www.drugs.com/ventolin.html | Dupixent: https://www.drugs.com/dupixent.html | Xopenex: https://www.drugs.com/xopenex.html | Anoro Ellipta: https://www.drugs.com/anoro-ellipta.html | COPD Other names: Bronchitis with Airway Obstruction; Bronchitis, Chronic; Chronic Bronchitis; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; Emphysema A group of lung diseases characterized by limited airflow with variable degrees of air sack enlargement and lung tissue destruction. Emphysema and chronic bronchitis are the most common forms of chronic obstructive pulmonary disease. | null | null | https://www.drugs.com/pro/breyna.html | https://www.drugs.com/condition/chronic-obstructive-pulmonary-disease.html | ||
budesonide / formoterol / glycopyrrolate | COPD | hives ; difficulty breathing; swelling of your face, lips, tongue, or throat. Budesonide, formoterol, and glycopyrrolate may cause serious side effects. Call your doctor at once if you have: worsened breathing problems; wheezing, choking, or other breathing problems after using this medication; tremors, nervousness , chest pain, fast or pounding heartbeats; sores or white patches in your mouth and throat, pain when swallowing; flu symptoms, body aches, unusual tiredness; painful or burning when you urinate, little or no urination; blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights; low potassium level--leg cramps, constipation , irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; signs of a lung infection--fever, chills, cough with mucus, chest pain, feeling short of breath; or signs of a hormonal disorder--tiredness or weakness, feeling light-headed, nausea , vomiting . Common side effects of budesonide, formoterol, and glycopyrrolate may include: throat pain or irritation; white patches in your mouth or throat; headache , joint pain, muscle spasms; pounding heartbeats, feeling anxious; high blood sugar levels; painful or difficult urination; nausea, diarrhea ; cough, hoarse voice; flu symptoms; or cold symptoms such as stuffy or runny nose , sneezing, sinus pain, sore throat . | budesonide, formoterol, and glycopyrrolate | Bronchodilator combinations | Breztri Aerosphere | 0% | Rx | N | X | COPD Other names: Bronchitis with Airway Obstruction; Bronchitis, Chronic; Chronic Bronchitis; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; Emphysema A group of lung diseases characterized by limited airflow with variable degrees of air sack enlargement and lung tissue destruction. Emphysema and chronic bronchitis are the most common forms of chronic obstructive pulmonary disease. | 6.7 | 3 | https://www.drugs.com/mtm/budesonide-formoterol-and-glycopyrrolate.html | https://www.drugs.com/condition/chronic-obstructive-pulmonary-disease.html | ||
Duaklir Pressair | COPD | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: wheezing, choking, or other breathing problems after using this medicine; worsening breathing problems; tremors, nervousness, chest pain, fast or pounding heartbeats; severe headache, pounding in your neck or ears; painful or difficult urination, or urinating more often; blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights; high blood sugar - increased thirst or urination, hunger, dry mouth, fruity breath odor; or low potassium level - leg cramps, constipation , irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling. Common Duaklir Pressair side effects may include: headache; back pain ; or cold symptoms such as stuffy nose, sneezing, sore throat . | aclidinium and formoterol | Bronchodilator combinations | 0% | Rx | N | COPD Other names: Bronchitis with Airway Obstruction; Bronchitis, Chronic; Chronic Bronchitis; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; Emphysema A group of lung diseases characterized by limited airflow with variable degrees of air sack enlargement and lung tissue destruction. Emphysema and chronic bronchitis are the most common forms of chronic obstructive pulmonary disease. | null | null | https://www.drugs.com/duaklir-pressair.html | https://www.drugs.com/condition/chronic-obstructive-pulmonary-disease.html | ||||
formoterol / glycopyrrolate | COPD | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Formoterol and glycopyrrolate may cause serious side effects. Call your doctor at once if you have: tremors, nervousness , chest pain, fast or pounding heartbeats; wheezing, choking, or other breathing problems after using this medicine; painful or difficult urination; blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights; high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling. Common side effects of formoterol and glycopyrrolate may include: cough; or urination problems. | formoterol and glycopyrrolate | Bronchodilator combinations | Bevespi Aerosphere | 0% | Rx | N | X | Trelegy Ellipta: https://www.drugs.com/trelegy-ellipta.html | prednisone: https://www.drugs.com/prednisone.html | Symbicort: https://www.drugs.com/symbicort.html | Ventolin: https://www.drugs.com/cons/ventolin.html | Breo Ellipta: https://www.drugs.com/breo-ellipta.html | Spiriva: https://www.drugs.com/spiriva.html | Ventolin HFA: https://www.drugs.com/ventolin.html | Xopenex: https://www.drugs.com/xopenex.html | Anoro Ellipta: https://www.drugs.com/anoro-ellipta.html | Stiolto Respimat: https://www.drugs.com/stiolto-respimat.html | COPD Other names: Bronchitis with Airway Obstruction; Bronchitis, Chronic; Chronic Bronchitis; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; Emphysema A group of lung diseases characterized by limited airflow with variable degrees of air sack enlargement and lung tissue destruction. Emphysema and chronic bronchitis are the most common forms of chronic obstructive pulmonary disease. | 7.5 | 5 | https://www.drugs.com/mtm/formoterol-and-glycopyrrolate.html | https://www.drugs.com/condition/chronic-obstructive-pulmonary-disease.html | |
ivermectin | Covid 19 | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: eye pain or redness, puffy eyes, problems with your vision; severe skin rash , itching, or rash with pus; confusion, change in your mental status, balance problems, trouble walking; fever, swollen glands, stomach pain, joint pain, swelling in your hands or feet; fast heart rate , trouble breathing; loss of bladder or bowel control; neck or back pain , seizure (convulsions); or a light-headed feeling, like you might pass out. Common ivermectin side effects may include: headache , muscle aches; dizziness ; nausea , diarrhea ; or mild skin rash. | ivermectin (oral) | Anthelmintics | Stromectol | 100% | Rx | C | N | X | albendazole: https://www.drugs.com/mtm/albendazole.html | Stromectol: https://www.drugs.com/mtm/stromectol.html | Albenza: https://www.drugs.com/mtm/albenza.html | moxidectin: https://www.drugs.com/cons/moxidectin.html | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | 7.8 | 17 | https://www.drugs.com/ivermectin.html | https://www.drugs.com/condition/covid-19.html |
remdesivir | Covid 19 | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Some side effects may occur during or after the injection. Tell your caregiver right away if you have: severe headache , pounding in your neck or ears; fast, slow, or pounding heartbeats; wheezing, trouble breathing; swelling in your face; nausea ; fever, chills, or shivering; itching, sweating; or a light-headed feeling, like you might pass out; Common side effects of remdesivir may include: nausea; or abnormal liver function tests . | remdesivir | Investigational drugs, Purine nucleosides | Veklury | 42% | Rx | N | X | Paxlovid: https://www.drugs.com/paxlovid.html | molnupiravir: https://www.drugs.com/molnupiravir.html | Actemra: https://www.drugs.com/actemra.html | Lagevrio: https://www.drugs.com/cons/lagevrio.html | Pfizer-BioNTech COVID-19 Vaccine: https://www.drugs.com/pfizer-biontech-covid-19-vaccine.html | baricitinib: https://www.drugs.com/mtm/baricitinib.html | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | 5.2 | 34 | https://www.drugs.com/mtm/remdesivir.html | https://www.drugs.com/condition/covid-19.html | |
Pfizer-BioNTech COVID-19 Vaccine | Covid 19 | hives , rash; dizziness , weakness, fast heartbeats; difficult breathing; swelling of your face, lips, tongue, or throat. Your vaccination provider may want to watch you for a short time after your shot, to make sure you don't have an allergic reaction. You will be treated quickly if you have a reaction right after you receive the vaccine. You should not receive this vaccine again if the first shot caused a severe allergic reaction. Your doctor or vaccination provider will determine if you can safely receive another COVID-19 vaccine. Not all possible side effects are known. Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine. Some people receiving Pfizer-BioNTech COVID-19 Vaccine had inflammation of the heart muscle or the lining around the heart within a few days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if you have: chest pain; shortness of breath; or fast or pounding heartbeats or fluttering in your chest. Not all possible side effects are known. Common Pfizer-BioNTech COVID-19 Vaccine side effects may include: fever, chills, swollen glands, not feeling well; pain, redness, or swelling where the shot was given; feeling tired; or headache, muscle pain, joint pain. | COVID-19 (coronavirus 2019) vaccine, Pfizer | Viral vaccines | Comirnaty | 40% | Rx | N | Paxlovid: https://www.drugs.com/paxlovid.html | molnupiravir: https://www.drugs.com/molnupiravir.html | remdesivir: https://www.drugs.com/mtm/remdesivir.html | Actemra: https://www.drugs.com/actemra.html | Lagevrio: https://www.drugs.com/cons/lagevrio.html | baricitinib: https://www.drugs.com/mtm/baricitinib.html | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | 7.4 | 11 | https://www.drugs.com/pfizer-biontech-covid-19-vaccine.html | https://www.drugs.com/condition/covid-19.html | ||
Paxlovid | Covid 19 | Possible side effects of Paxlovid are: Liver Problems. Tell your healthcare provider right away if you have any of these signs and symptoms of liver problems: loss of appetite, yellowing of your skin and the whites of eyes (jaundice), dark-colored urine, pale colored stools and itchy skin, stomach area (abdominal) pain. Resistance to HIV Medicines. If you have untreated HIV infection, Paxlovid may lead to some HIV medicines not working as well in the future. Other possible side effects include: altered sense of taste diarrhea high blood pressure muscle aches These are not all the possible side effects of Paxlovid. Not many people have taken Paxlovid. Serious and unexpected side effects may happen. Paxlovid is still being studied, so it is possible that all of the risks are not known at this time. Paxlovid side effects | nirmatrelvir and ritonavir | Antiviral combinations | 32% | Rx | N | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | 6.8 | 282 | https://www.drugs.com/paxlovid.html | https://www.drugs.com/condition/covid-19.html | ||||
Actemra | Covid 19 | hives ; chest pain, difficulty breathing, feeling like you might pass out; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: severe stomach cramps, bloating , diarrhea or constipation ; unusual bleeding - nosebleeds , bleeding gums, abnormal vaginal bleeding , any bleeding that will not stop, blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds; liver problems - loss of appetite, right-sided stomach pain, vomiting, confusion, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); signs of infection - fever, chills, aches, skin sores, diarrhea, burning when you urinate; signs of tuberculosis: cough, shortness of breath, night sweats , loss of appetite, weight loss, and feeling very tired; or signs of perforation (a hole or tear) in your stomach or intestines - fever, ongoing stomach pain, change in bowel habits. Common Actemra side effects may include: runny or stuffy nose, sinus pain, sore throat ; headache ; increased blood pressure; abnormal liver function tests ; or pain, swelling, burning, or irritation where an injection was given. | tocilizumab | Interleukin inhibitors | 31% | Rx | C | N | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/actemra.html | https://www.drugs.com/condition/covid-19.html | |||
tocilizumab | Covid 19 | hives ; chest pain, difficulty breathing, feeling like you might pass out; swelling of your face, lips, tongue, or throat. Tocilizumab may cause serious side effects. Call your doctor at once if you have: severe stomach cramps, bloating , diarrhea or constipation ; unusual bleeding-- nosebleeds , bleeding gums, abnormal vaginal bleeding , any bleeding that will not stop, blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds; liver problems--loss of appetite, right-sided stomach pain, vomiting, confusion, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); signs of infection--fever, chills, aches, skin sores, diarrhea, burning when you urinate; signs of tuberculosis: cough, shortness of breath, night sweats , loss of appetite, weight loss, and feeling very tired; or signs of perforation (a hole or tear) in your stomach or intestines--fever, ongoing stomach pain, change in bowel habits. Common side effects of tocilizumab may include: runny or stuffy nose, sinus pain, sore throat ; headache ; increased blood pressure; abnormal liver function tests ; or pain, swelling, burning, or irritation where an injection was given. | tocilizumab | Interleukin inhibitors | Actemra | 31% | Rx | C | N | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/mtm/tocilizumab.html | https://www.drugs.com/condition/covid-19.html | ||
anakinra | Covid 19 | hives , sweating, severe itching; wheezing, difficult breathing; fast or pounding heartbeats; dizziness , fainting; swelling of your face, lips, tongue, or throat. If you are using anakinra for DIRA, you may have an increased risk of allergic reactions , especially in the first weeks of treatment. Anakinra may cause serious side effects. Call your doctor at once if you have: fever or chills; low white blood cell counts--mouth sores, skin sores, sore throat ; signs of tuberculosis: fever, cough, night sweats , loss of appetite, weight loss , and feeling very tired. Common side effects of anakinra may include: abnormal liver function tests ; rash; worsening arthritis symptoms; nausea , vomiting , diarrhea , stomach pain; headache ; joint pain; flu symptoms; cold symptoms such as stuffy nose, sneezing, sore throat; or redness, bruising, itching, stinging, or swelling where the injection was given. | anakinra | Antirheumatics, Interleukin inhibitors | Kineret | 30% | Rx | B | N | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/mtm/anakinra.html | https://www.drugs.com/condition/covid-19.html | ||
Kineret | Covid 19 | hives , sweating, severe itching; wheezing, difficult breathing; fast or pounding heartbeats; dizziness , fainting; swelling of your face, lips, tongue, or throat. If you are using Kineret for DIRA, you may have an increased risk of allergic reactions , especially in the first weeks of treatment. Call your doctor at once if you have: fever or chills; low white blood cell counts - mouth sores, skin sores, sore throat; or signs of tuberculosis - fever, cough, night sweats , loss of appetite, weight loss , and feeling very tired. Common Kineret side effects may include: abnormal liver function tests; rash; worsening arthritis symptoms; nausea , vomiting , diarrhea , stomach pain; headache ; joint pain; flu symptoms; cold symptoms such as stuffy nose, sneezing, sore throat ; or redness, bruising, itching, stinging, or swelling where the injection was given. | anakinra | Antirheumatics, Interleukin inhibitors | 30% | Rx | B | N | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/kineret.html | https://www.drugs.com/condition/covid-19.html | |||
Moderna COVID-19 Vaccine | Covid 19 | hives , rash, dizziness , weakness, fast heartbeats; difficult breathing; swelling of your face, lips, tongue, or throat. Your vaccination provider may want to watch you for a short time after your shot, to make sure you don't have an allergic reaction. You will be treated quickly if you have a reaction right after you receive the vaccine. You should not receive this vaccine again if the first shot caused a severe allergic reaction. Your doctor or vaccination provider will determine if you can safely receive another COVID-19 vaccine. Becoming infected with COVID-19 is much more dangerous to your health than receiving Moderna COVID-19 Vaccine. Some people receiving Moderna COVID-19 Vaccine had inflammation of the heart muscle or the lining around the heart within a few days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if you have: chest pain; shortness of breath; or fast or pounding heartbeats or fluttering in your chest. Not all possible side effects are known. Common Moderna COVID-19 Vaccine side effects may include: fever, chills; redness or a hardness and swelling where the shot was given; swelling or tenderness under your arm; nausea, vomiting; feeling tired; or headache, muscle pain, joint pain. | COVID-19 (coronavirus 2019) vaccine, Moderna (KOE vid (koe ROE na vye rus) VAX een) Brand names: Moderna COVID-19 Vaccine PF, Spikevax COVID-19 vaccine | Viral vaccines | 30% | Rx | N | Paxlovid: https://www.drugs.com/paxlovid.html | molnupiravir: https://www.drugs.com/molnupiravir.html | remdesivir: https://www.drugs.com/mtm/remdesivir.html | Actemra: https://www.drugs.com/actemra.html | Lagevrio: https://www.drugs.com/cons/lagevrio.html | Pfizer-BioNTech COVID-19 Vaccine: https://www.drugs.com/pfizer-biontech-covid-19-vaccine.html | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | 5.2 | 27 | https://www.drugs.com/moderna-covid-19-vaccine.html | https://www.drugs.com/condition/covid-19.html | |||
Olumiant | Covid 19 | Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction to Olumiant: hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Some people taking Olumiant have developed heart attacks, strokes, or serious blood clots. Stop taking Olumiant and seek emergency medical attention if you have: sudden shortness of breath; chest pain or pressure that may spread to your jaw, shoulder, arms, or back; nausea, vomiting , cold sweat; a light-headed feeling, like you might pass out; weakness on one side of your body; slurred speech, drooping on one side of your mouth; or pain, swelling, or redness in an arm or a leg. Call your doctor at once if you have: fever, chills, night sweats, constant tiredness; wheezing, trouble breathing, severe or worsening cough; increased urination, pain or burning when you urinate; unexplained weight loss ; lumps in your neck, armpits, or groin; signs of shingles - flu-like symptoms, tingly or painful blistering rash on one side of your body; a hole (perforation) in your digestive tract - fever, severe stomach pain, diarrhea or changes in bowel habits; or signs of hepatitis - loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Common Olumiant side effects may include: cold sores , shingles; nausea; or cold symptoms such as stuffy nose, sneezing, sore throat . | baricitinib | Antirheumatics, Selective immunosuppressants | 30% | Rx | N | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | 1 | 2 | https://www.drugs.com/olumiant.html | https://www.drugs.com/condition/covid-19.html | ||||
Veklury | Covid 19 | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Some side effects may occur during or after the injection. Tell your caregiver right away if you have: severe headache , pounding in your neck or ears; fast, slow, or pounding heartbeats; wheezing, trouble breathing; swelling in your face; nausea ; fever, chills, or shivering; itching, sweating; or a light-headed feeling, like you might pass out; Common Veklury side effects may include include: nausea; or abnormal liver function tests . | remdesivir | Investigational drugs, Purine nucleosides | 11% | Rx | N | X | Paxlovid: https://www.drugs.com/paxlovid.html | molnupiravir: https://www.drugs.com/molnupiravir.html | remdesivir: https://www.drugs.com/mtm/remdesivir.html | Actemra: https://www.drugs.com/actemra.html | Lagevrio: https://www.drugs.com/cons/lagevrio.html | Pfizer-BioNTech COVID-19 Vaccine: https://www.drugs.com/pfizer-biontech-covid-19-vaccine.html | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/veklury.html | https://www.drugs.com/condition/covid-19.html | ||
molnupiravir | Covid 19 | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor if you have any new or worsening symptoms. Common molnupiravir side effects may include: diarrhea , nausea ; or dizziness . | molnupiravir | Miscellaneous antivirals | 9% | Rx | N | Paxlovid: https://www.drugs.com/paxlovid.html | remdesivir: https://www.drugs.com/mtm/remdesivir.html | Actemra: https://www.drugs.com/actemra.html | Lagevrio: https://www.drugs.com/cons/lagevrio.html | Pfizer-BioNTech COVID-19 Vaccine: https://www.drugs.com/pfizer-biontech-covid-19-vaccine.html | baricitinib: https://www.drugs.com/mtm/baricitinib.html | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | 4.7 | 4 | https://www.drugs.com/molnupiravir.html | https://www.drugs.com/condition/covid-19.html | |||
REGEN-COV | Covid 19 | hives , itching; difficult breathing; swelling of your face, lips, tongue, or throat. Some side effects may occur during the Regen-Cov injection. Tell your caregiver right away if you have: throat irritation, swelling in your face or throat; dizziness , a light-headed feeling (like you might pass out); chest pain, wheezing, shortness of breath; fever, chills, sweating, nausea , flushing (sudden warmth, redness, or tingly feeling); fast or slow heartbeats, headache , pounding in your neck or ears; weakness, tiredness; rash, itching; or muscle pain. Call your doctor if you have new or worsening symptoms after the infusion, such as fever, confusion, weakness, tiredness, trouble breathing, or fast or slow heartbeats. Less serious side effects may also occur, or you may have none at all. Not all possible side effects are known. This is not a complete list of Regen-Cov's side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. What other drugs will affect Regen-Cov? Other drugs may interact with casirivimab and imdevimab, including prescription and over-the-counter medicines, vitamins , and herbal products . Tell your doctor about all other medicines you use. REGEN-COV drug interactions | casirivimab and imdevimab | Antiviral combinations | 5% | Rx | N | Paxlovid: https://www.drugs.com/paxlovid.html | molnupiravir: https://www.drugs.com/molnupiravir.html | remdesivir: https://www.drugs.com/mtm/remdesivir.html | Actemra: https://www.drugs.com/actemra.html | Lagevrio: https://www.drugs.com/cons/lagevrio.html | Pfizer-BioNTech COVID-19 Vaccine: https://www.drugs.com/pfizer-biontech-covid-19-vaccine.html | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | 5.5 | 2 | https://www.drugs.com/regen-cov.html | https://www.drugs.com/condition/covid-19.html | |||
sotrovimab | Covid 19 | hives , itching; difficult breathing; swelling of your face, lips, tongue, or throat. Some side effects may occur during or up to 24 hours after the injection. Tell your medical caregivers right away if you have: throat irritation, swelling in your face or throat; fast, slow, or uneven heart rate; confusion, dizziness , a light-headed feeling (like you might pass out); chest pain, wheezing, shortness of breath; fever, chills, sweating, nausea , weakness, tiredness; pounding in your neck or ears; rash, itching; or headache , muscle pain. Call your doctor if you have new or worsening symptoms after the infusion, such as fever, confusion, weakness, tiredness, trouble breathing, or fast or slow heartbeats. Common side effects of sotrovimab may include: diarrhea ; or rash. Not all possible side effects are known. | sotrovimab | Miscellaneous antivirals | 5% | Rx | N | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/mtm/sotrovimab.html | https://www.drugs.com/condition/covid-19.html | ||||
bamlanivimab / etesevimab | Covid 19 | null | 3% | Rx | U | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | 1 | 1 | https://www.drugs.com/pro/bamlanivimab-and-etesevimab-injection.html | https://www.drugs.com/condition/covid-19.html | ||||||
Lagevrio | Covid 19 | Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Less common Diarrhea dizziness headache hives, itching, skin rash nausea redness of the skin vomiting Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Lagevrio side effects | molnupiravir (oral route) | Miscellaneous antivirals | 2% | Rx | N | Paxlovid: https://www.drugs.com/paxlovid.html | molnupiravir: https://www.drugs.com/molnupiravir.html | remdesivir: https://www.drugs.com/mtm/remdesivir.html | Actemra: https://www.drugs.com/actemra.html | Pfizer-BioNTech COVID-19 Vaccine: https://www.drugs.com/pfizer-biontech-covid-19-vaccine.html | baricitinib: https://www.drugs.com/mtm/baricitinib.html | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/cons/lagevrio.html | https://www.drugs.com/condition/covid-19.html | |||
sars-cov-2 (covid-19) ad26 vaccine, recombinant | Covid 19 | Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor or nurse immediately if any of the following side effects occur: More common Difficulty in moving fever headache joint pain or swelling muscle aches, cramping, pains, or stiffness nausea unusual tiredness or weakness Incidence not known Anxiety black, tarry stools bleeding gums blood in the urine or stool bloody nose blue or pale skin blurred vision chest pain or discomfort chills confusion continuing ringing or buzzing or other unexplained noise in the ears cough dizziness or lightheadedness fainting fast heartbeat hearing loss heavier menstrual periods hives or welts, itching, skin rash inability to move the arms and legs numbness, weakness, or tingling in the arms or legs pain, redness, or swelling in the arm or leg pinpoint red spots on the skin redness of the skin seizures slurred speech stomach pain sudden, severe weakness or numbness in the arm or leg sudden loss of coordination trouble breathing unusual bleeding or bruising vision changes vomiting blood Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: More common Pain, redness, or swelling at the injection site Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Sars-cov-2 (covid-19) ad26 vaccine, recombinant side effects | 2% | Rx | N | Paxlovid: https://www.drugs.com/paxlovid.html | molnupiravir: https://www.drugs.com/molnupiravir.html | remdesivir: https://www.drugs.com/mtm/remdesivir.html | Actemra: https://www.drugs.com/actemra.html | Lagevrio: https://www.drugs.com/cons/lagevrio.html | Pfizer-BioNTech COVID-19 Vaccine: https://www.drugs.com/pfizer-biontech-covid-19-vaccine.html | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | 6.5 | 4 | https://www.drugs.com/cons/sars-cov-2-covid-19-vaccine-adenovirus-26-vector-janssen-intramuscular.html | https://www.drugs.com/condition/covid-19.html | |||||
sars-cov-2 mrna (tozinameran) vaccine | Covid 19 | Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor or nurse immediately if any of the following side effects occur: More common Chills diarrhea fever headache irritability joint or muscle pain swollen, painful, or tender lymph glands in the neck, armpit, or groin unusual tiredness or weakness Less common Nausea vomiting Rare Decreased appetite general feeling of discomfort or illness pain in the arms rash Incidence not known Anxiety blue or pale skin chest discomfort or tightness chest pain, possible moving to the left arm, neck, or shoulder cough difficulty swallowing dizziness fast heartbeat fainting large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue trouble breathing Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: More common Pain, redness, or swelling at the injection site Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Sars-cov-2 mrna (tozinameran) vaccine side effects | 2% | Rx | N | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | 7.4 | 11 | https://www.drugs.com/cons/sars-cov-2-covid-19-vaccine-mrna-lnp-spike-protein-pfizer-intramuscular.html | https://www.drugs.com/condition/covid-19.html | ||||||
bamlanivimab and etesevimab | Covid 19 | Possible side effects of bamlanivimab and etesevimab include: Allergic reactions. Allergic reactions can happen during and after infusion with bamlanivimab and etesevimab. Tell your healthcare provider right away if you get any of the following signs and symptoms of allergic reactions: fever, chills, nausea, headache, shortness of breath, low or high blood pressure, rapid or slow heart rate, chest discomfort or pain, weakness, confusion, feeling tired, wheezing, swelling of your lips, face, or throat, rash including hives, itching, muscle aches, dizziness, and sweating. These reactions may be severe or life threatening. Worsening symptoms after treatment: You may experience new or worsening symptoms after infusion, including fever, difficulty breathing, rapid or slow heart rate, tiredness, weakness or confusion. If these occur, contact your healthcare provider or seek immediate medical attention as some of these events have required hospitalization. It is unknown if these events are related to treatment or are due to the progression of COVID-19. The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site. These are not all the possible side effects of bamlanivimab and etesevimab. Not a lot of people have been given bamlanivimab and etesevimab. Serious and unexpected side effects may happen. Bamlanivimab and etesevimab are still being studied so it is possible that all of the risks are not known at this time. It is possible that bamlanivimab and etesevimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. Similarly, bamlanivimab and etesevimab may reduce your body's immune response to a vaccine for SARS-CoV-2. Specific studies have not been conducted to address these possible risks. Talk to your healthcare provider if you have any questions. What other treatment choices are there? Like bamlanivimab and etesevimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19. Go to https://www.drugs.com/condition/covid-19.html for information on medicines available to treat people with COVID-19. Your healthcare provider may talk with you about clinical trials you may be eligible for. It is your choice to be treated or not to be treated with bamlanivimab and etesevimab. Should you decide not to receive bamlanivimab and etesevimab or stop it at any time, it will not change your standard medical care. Pregnancy or Breastfeeding There is limited experience treating pregnant women or breastfeeding mothers with bamlanivimab and etesevimab. For a mother and unborn baby, the benefit of receiving bamlanivimab and etesevimab may be greater than the risk from the treatment. If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. How do I report side effects with bamlanivimab and etesevimab? Tell your healthcare provider right away if you have any side effect that bothers you or does not go away. Report side effects to FDA MedWatch at www.fda.gov/medwatch, call 1-800-FDA-1088, or contact Eli Lilly and Company on +1-855-545-5921. More about bamlanivimab and etesevimab (bamlanivimab / etesevimab) Reviews (1) FDA approval history Professional resources Prescribing Information Related treatment guides COVID-19 Post-Exposure Prophylaxis of COVID-19 Further information Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Medical Disclaimer Paxlovid A new investigational treatment for COVID-19: - Paxlovid Uses & Dosage Info - FDA Approval Status - How effective is Paxlovid? 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| 1% | Rx | U | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | 1 | 1 | https://www.drugs.com/bamlanivimab-and-etesevimab.html | https://www.drugs.com/condition/covid-19.html | ||||||
baricitinib | Covid 19 | Stop taking baricitinib and get emergency medical help if you have signs of an allergic reaction: hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Some people taking baricitinib have developed heart attacks, strokes, or serious blood clots. Stop taking baricitinib and seek emergency medical attention if you have: sudden shortness of breath; chest pain or pressure that may spread to your jaw, shoulder, arms, or back; nausea, vomiting , cold sweat; a light-headed feeling, like you might pass out; weakness on one side of your body; slurred speech, drooping on one side of your mouth; or pain, swelling, or redness in an arm or a leg. Baricitinib may cause serious side effects. Call your doctor at once if you have: fever, chills, night sweats, constant tiredness; wheezing, trouble breathing, severe or worsening cough; increased urination, pain or burning when you urinate; unexplained weight loss ; lumps in your neck, armpits, or groin; signs of shingles--flu-like symptoms, tingly or painful blistering rash on one side of your body; a hole (perforation) in your digestive tract--fever, severe stomach pain, diarrhea or changes in bowel habits; or signs of hepatitis--loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Common side effects of baricitinib may include: cold sores , shingles; nausea; or cold symptoms such as stuffy nose, sneezing, sore throat . | baricitinib | Antirheumatics, Selective immunosuppressants | Olumiant | 1% | Rx | N | Enbrel: https://www.drugs.com/enbrel.html | Humira: https://www.drugs.com/humira.html | Paxlovid: https://www.drugs.com/paxlovid.html | triamcinolone: https://www.drugs.com/triamcinolone.html | hydroxychloroquine: https://www.drugs.com/hydroxychloroquine.html | minoxidil topical: https://www.drugs.com/mtm/minoxidil-topical.html | Remicade: https://www.drugs.com/remicade.html | molnupiravir: https://www.drugs.com/molnupiravir.html | Rituxan: https://www.drugs.com/rituxan.html | remdesivir: https://www.drugs.com/mtm/remdesivir.html | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | 1 | 2 | https://www.drugs.com/mtm/baricitinib.html | https://www.drugs.com/condition/covid-19.html | ||
bebtelovimab | Covid 19 | Allergic reactions. Allergic reactions can happen during and after injection with bebtelovimab. Tell your healthcare provider right away if you or your child develop any of the following signs and symptoms of allergic reaction: fever difficulty breathing low oxygen level in your blood chills tiredness fast or slow heart rate chest discomfort or pain weakness confusion nausea headache shortness of breath low or high blood pressure wheezing swelling of your lips, face, or throat rash including hives itching muscle aches dizziness feeling faint, and sweating. These reactions may be severe or life threatening. Common side effects include infusion-related reactions, pruritus, and rash. The side effects of receiving any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the injection site. These are not all the possible side effects. Not many people have received bebtelovimab. Serious and unexpected side effects may happen. All of the risks are not known at this time. Contact your healthcare provider if you have any side effects that bother you or do not go away. Report side effects to FDA MedWatch at www.fda.gov/medwatch, or call 1-800-FDA-1088 or call Eli Lilly and Company, Inc. 1-855-LillyC19 (1-855-545-5921). It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. Similarly, bebtelovimab may reduce the body’s immune response to a vaccine for SARS-CoV-2. Talk to your healthcare provider if you have any questions. Bebtelovimab side effects | bebtelovimab | Miscellaneous antivirals | 1% | Rx | N | Paxlovid: https://www.drugs.com/paxlovid.html | molnupiravir: https://www.drugs.com/molnupiravir.html | remdesivir: https://www.drugs.com/mtm/remdesivir.html | Actemra: https://www.drugs.com/actemra.html | Lagevrio: https://www.drugs.com/cons/lagevrio.html | Pfizer-BioNTech COVID-19 Vaccine: https://www.drugs.com/pfizer-biontech-covid-19-vaccine.html | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | 2 | 2 | https://www.drugs.com/bebtelovimab.html | https://www.drugs.com/condition/covid-19.html | |||
Comirnaty | Covid 19 | Comirnaty may cause severe side effects including: Allergic reactions. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include: Difficulty breathing Swelling of your face and throat A fast heartbeat A bad rash all over your body Dizziness and weakness Myocarditis and pericarditis. Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) is a rare side effect and has have occurred in some people who have received the vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine and most individuals have had resolution of symptoms with conservative management. You should seek medical attention right away if you have any of the following symptoms after receiving the vaccine: Chest pain Shortness of breath Feelings of having a fast-beating, fluttering, or pounding heart Side effects can include: severe allergic reactions non-severe allergic reactions such as rash, itching, hives, or swelling of the face myocarditis (inflammation of the heart muscle) pericarditis (inflammation of the lining outside the heart) injection site pain tiredness headache muscle pain chills joint pain fever injection site swelling injection site redness nausea feeling unwell swollen lymph nodes (lymphadenopathy) diarrhea vomiting arm pain These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. If you experience a severe allergic reaction, call 911, or go to the nearest hospital. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away. Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Comirnaty side effects | COVID-19 Vaccine, mRNA | Viral vaccines | 1% | Rx | N | Paxlovid: https://www.drugs.com/paxlovid.html | molnupiravir: https://www.drugs.com/molnupiravir.html | remdesivir: https://www.drugs.com/mtm/remdesivir.html | Actemra: https://www.drugs.com/actemra.html | Lagevrio: https://www.drugs.com/cons/lagevrio.html | Pfizer-BioNTech COVID-19 Vaccine: https://www.drugs.com/pfizer-biontech-covid-19-vaccine.html | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/comirnaty.html | https://www.drugs.com/condition/covid-19.html | |||
nirmatrelvir / ritonavir | Covid 19 | liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Ritonavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken nirmatrelvir and ritonavir). Tell your doctor if you have: signs of a new infection--fever, night sweats , swollen glands, cold sores , cough, wheezing, diarrhea , weight loss ; trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence . Common side effects of nirmatrelvir and ritonavir may include: changes in your sense of taste; diarrhea; elevated blood pressure; or muscle pain. | nirmatrelvir and ritonavir Brand name: Paxlovid | Antiviral combinations | Paxlovid | 1% | Rx | N | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | 6.8 | 285 | https://www.drugs.com/mtm/nirmatrelvir-and-ritonavir.html | https://www.drugs.com/condition/covid-19.html | |||
sars-cov-2 (covid-19) mrna-1273 vaccine | Covid 19 | Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor or nurse immediately if any of the following side effects occur: More common Chills difficulty in moving fever headache joint pain muscle aches, cramps, pains, or stiffness nausea swollen joints unusual tiredness or weakness vomiting Incidence not known Anxiety blue or pale skin chest discomfort or tightness chest pain, possible moving to the left arm, neck, or shoulder cough difficulty swallowing dizziness fast heartbeat fainting puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue trouble breathing Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Incidence not known Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Sars-cov-2 (covid-19) mrna-1273 vaccine side effects | 1% | Rx | N | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | 5.2 | 27 | https://www.drugs.com/cons/sars-cov-2-covid-19-vaccine-mrna-lnp-spike-protein-moderna-intramuscular.html | https://www.drugs.com/condition/covid-19.html | ||||||
Pfizer-BioNTech COVID-19 (5y-11y) Bivalent Booster Vaccine PF | Covid 19 | hives , rash; dizziness , weakness, fast heartbeats; difficult breathing; swelling of the face, lips, tongue, or throat. Your child's vaccination provider may want to watch him/her for a short time after the shot, to make sure your child does not have an allergic reaction. Your child will be treated quickly if he/she has a reaction right after he/she receives the vaccine. Your child should not receive this vaccine if the first shot of COVID-19 vaccine caused an allergic reaction. The doctor or vaccination provider will determine if your child can safely receive this vaccine. Not all possible side effects are known. Becoming infected with COVID-19 is much more dangerous to your child's health than receiving this vaccine. Some people receiving this vaccine had inflammation of the heart muscle or the lining around the heart within a few days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if your child has: chest pain; shortness of breath; or fast or pounding heartbeats or fluttering in the chest. Common side effects of Pfizer-BioNTech COVID-19 (5y-11y) Bivalent Booster VaccinePF may include: fever, chills; redness or a hardness and swelling where the shot was given; swelling or tenderness under the arm; nausea, vomiting; feeling tired; or headache, muscle pain, joint pain. | COVID-19 (coronavirus 2019, 5y-11) bivalent booster vaccine, Pfizer | Viral vaccines | 0% | Rx | N | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/mtm/pfizer-biontech-covid-19-5y-11y-bivalent-booster-vaccinepf.html | https://www.drugs.com/condition/covid-19.html | ||||
Pfizer-BioNTech COVID-19 (12y+) Bivalent Booster Vaccine PF | Covid 19 | hives , rash; dizziness , weakness, fast heartbeats; difficult breathing; swelling of your face, lips, tongue, or throat. Your vaccination provider may want to watch you for a short time after your shot, to make sure you don't have an allergic reaction. You will be treated quickly if you have a reaction right after you receive the vaccine. You should not receive this vaccine if the first shot of COVID-19 vaccine caused an allergic reaction. Your doctor or vaccination provider will determine if you can safely receive this vaccine. Not all possible side effects are known. Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine. Some people receiving this vaccine had inflammation of the heart muscle or the lining around the heart within a few days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if you have: chest pain; shortness of breath; or fast or pounding heartbeats or fluttering in your chest. Common side effects of Pfizer-BioNTech COVID-19 (12y+) Bivalent Booster Vaccine PF may include: fever, chills; redness or a hardness and swelling where the shot was given; swelling or tenderness under your arm; nausea, vomiting; feeling tired; or headache, muscle pain, joint pain. | COVID-19 (coronavirus 2019, 12y+) bivalent booster vaccine, Pfizer | Viral vaccines | 0% | Rx | N | Paxlovid: https://www.drugs.com/paxlovid.html | molnupiravir: https://www.drugs.com/molnupiravir.html | remdesivir: https://www.drugs.com/mtm/remdesivir.html | Actemra: https://www.drugs.com/actemra.html | Lagevrio: https://www.drugs.com/cons/lagevrio.html | Pfizer-BioNTech COVID-19 Vaccine: https://www.drugs.com/pfizer-biontech-covid-19-vaccine.html | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/mtm/pfizer-biontech-covid-19-12y-bivalent-booster-vaccine-pf.html | https://www.drugs.com/condition/covid-19.html | |||
sars-cov-2 (covid-19) mrna (tozinameran 5y-11y) bivalent booster vaccine | Covid 19 | hives , rash; dizziness , weakness, fast heartbeats; difficult breathing; swelling of the face, lips, tongue, or throat. Your child's vaccination provider may want to watch him/her for a short time after the shot, to make sure your child does not have an allergic reaction. Your child will be treated quickly if he/she has a reaction right after he/she receives the vaccine. Your child should not receive this vaccine if the first shot of COVID-19 vaccine caused an allergic reaction. The doctor or vaccination provider will determine if your child can safely receive this vaccine. Not all possible side effects are known. Becoming infected with COVID-19 is much more dangerous to your child's health than receiving this vaccine. Some people receiving this vaccine had inflammation of the heart muscle or the lining around the heart within a few days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if your child has: chest pain; shortness of breath; or fast or pounding heartbeats or fluttering in the chest. Common side effects of COVID-19 (coronavirus 2019, 5y-11) bivalent booster vaccine, Pfizer may include: fever, chills; redness or a hardness and swelling where the shot was given; swelling or tenderness under the arm; nausea, vomiting; feeling tired; or headache, muscle pain, joint pain. | COVID-19 (coronavirus 2019, 5y-11) bivalent booster vaccine, Pfizer | Viral vaccines | 0% | Rx | N | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/mtm/covid-19-coronavirus-2019-5y-11-bivalent-booster-vaccine-pfizer.html | https://www.drugs.com/condition/covid-19.html | ||||
sars-cov-2 (covid-19) mrna (tozinameran 12y+) bivalent booster vaccine | Covid 19 | hives , rash; dizziness , weakness, fast heartbeats; difficult breathing; swelling of your face, lips, tongue, or throat. Your vaccination provider may want to watch you for a short time after your shot, to make sure you don't have an allergic reaction. You will be treated quickly if you have a reaction right after you receive the vaccine. You should not receive this vaccine if the first shot of COVID-19 vaccine caused an allergic reaction. Your doctor or vaccination provider will determine if you can safely receive this vaccine. Not all possible side effects are known. Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine. Some people receiving this vaccine had inflammation of the heart muscle or the lining around the heart within a few days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if you have: chest pain; shortness of breath; or fast or pounding heartbeats or fluttering in your chest. Common side effects of COVID-19 (coronavirus 2019, 12y+) bivalent booster vaccine, Pfizer may include: fever, chills; redness or a hardness and swelling where the shot was given; swelling or tenderness under your arm; nausea, vomiting; feeling tired; or headache, muscle pain, joint pain. | COVID-19 (coronavirus 2019, 12y+) bivalent booster vaccine, Pfizer | Viral vaccines | Pfizer-BioNTech COVID-19 (12y+) Bivalent Booster Vaccine PF | 0% | Rx | N | Paxlovid: https://www.drugs.com/paxlovid.html | molnupiravir: https://www.drugs.com/molnupiravir.html | remdesivir: https://www.drugs.com/mtm/remdesivir.html | Actemra: https://www.drugs.com/actemra.html | Lagevrio: https://www.drugs.com/cons/lagevrio.html | Pfizer-BioNTech COVID-19 Vaccine: https://www.drugs.com/pfizer-biontech-covid-19-vaccine.html | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/mtm/covid-19-coronavirus-2019-12y-bivalent-booster-vaccine-pfizer.html | https://www.drugs.com/condition/covid-19.html | ||
sars-cov-2 (covid-19) mrna-1273 (bivalent booster) vaccine | Covid 19 | Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor or nurse immediately if any of the following side effects occur: More common Chills difficulty in moving headache joint pain muscle aches, cramps, pains, or stiffness nausea swollen joints unusual tiredness or weakness vomiting Less common Fever Incidence not known Anxiety blue or pale skin chest discomfort or tightness chest pain, possible moving to the left arm, neck, or shoulder cough difficulty swallowing dizziness fast heartbeat fainting puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue trouble breathing Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Incidence not known Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Sars-cov-2 (covid-19) mrna-1273 (bivalent booster) vaccine side effects | 0% | Rx | N | Paxlovid: https://www.drugs.com/paxlovid.html | molnupiravir: https://www.drugs.com/molnupiravir.html | remdesivir: https://www.drugs.com/mtm/remdesivir.html | Actemra: https://www.drugs.com/actemra.html | Lagevrio: https://www.drugs.com/cons/lagevrio.html | Pfizer-BioNTech COVID-19 Vaccine: https://www.drugs.com/pfizer-biontech-covid-19-vaccine.html | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/cons/sars-cov-2-covid-19-vaccine-mrna-bivalent-moderna-intramuscular.html | https://www.drugs.com/condition/covid-19.html | |||||
sars-cov-2 (covid-19) nvx-cov2373 vaccine, recombinant | Covid 19 | Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor or nurse immediately if any of the following side effects occur: More common Fever headache joint or muscle pain nausea unusual tiredness or weakness vomiting Rare Swollen, painful, or tender lymph glands in neck, armpit, or groin Incidence not known Anxiety blue or pale skin burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings chest discomfort or tightness chest pain, possibly moving to the left arm, neck, or shoulder chills cough difficulty swallowing dizziness fainting fast heartbeat hives, itching, skin rash puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue trouble breathing Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: More common Pain, redness, or swelling at the injection site Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Sars-cov-2 (covid-19) nvx-cov2373 vaccine, recombinant side effects | 0% | Rx | N | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/cons/sars-cov-2-covid-19-vaccine-protein-subunit-adjuvanted-novavax-intramuscular.html | https://www.drugs.com/condition/covid-19.html | ||||||
sars-cov-2 mrna (tozinameran 6m-4y) vaccine | Covid 19 | hives , rash; dizziness , weakness, fast heartbeats; difficult breathing; swelling of the face, lips, tongue, or throat. The vaccination provider may want to watch your child for a short time after the shot, to make sure he or she doesn't have an allergic reaction. Your child will be treated quickly if he or she has a reaction right after receiving the vaccine. Your child should not receive this vaccine again if the first shot caused an allergic reaction. The doctor or vaccination provider will determine if he or she can safely receive another COVID-19 vaccine. Not all possible side effects are known. Becoming infected with COVID-19 is much more dangerous to your child's health than receiving this vaccine. Some people receiving this vaccine had inflammation of the heart muscle or the lining around the heart within a few days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if your child has: chest pain; shortness of breath; or fast or pounding heartbeats or fluttering in the chest. Common side effects of COVID-19 (coronavirus 2019, 6m-4y) vaccine, Pfizer may include: fever, chills, swollen glands, not feeling well; pain, redness, or swelling where the shot was given; feeling tired; or headache, muscle pain, joint pain. | COVID-19 (coronavirus 2019, 6m-4y) vaccine, Pfizer | Viral vaccines | Pfizer-BioNTech COVID-19 (6m-4y) Vaccine PF | 0% | Rx | N | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/mtm/covid-19-coronavirus-2019-6m-4y-vaccine-pfizer.html | https://www.drugs.com/condition/covid-19.html | |||
sars-cov-2 mrna-1273 (6m-5y) vaccine | Covid 19 | hives , rash; dizziness , weakness, fast heartbeats; difficult breathing; swelling of your face, lips, tongue, or throat. Your vaccination provider may want to watch you for a short time after your shot, to make sure you don't have an allergic reaction. You will be treated quickly if you have a reaction right after you receive the vaccine. You should not receive this vaccine again if the first shot caused an allergic reaction. Your doctor or vaccination provider will determine if you can safely receive another COVID-19 vaccine. Not all possible side effects are known. Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine. Some people receiving this vaccine had inflammation of the heart muscle or the lining around the heart within a few days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if you have: chest pain; shortness of breath; or fast or pounding heartbeats or fluttering in your chest. Common side effects of COVID-19 (coronavirus 2019, 6m-5y) vaccine, Moderna may include: fever, chills; redness or a hardness and swelling where the shot was given; swelling or tenderness under your arm; nausea, vomiting; feeling tired; or headache, muscle pain, joint pain. | COVID-19 (coronavirus 2019, 6m-5y) vaccine, Moderna (KOE vid (koe ROE na vye rus) VAX een) Brand name: Moderna COVID-19 (6m-5y) Vaccine PF | Viral vaccines | Moderna COVID-19 (6m-5y) Vaccine PF | 0% | Rx | N | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/mtm/covid-19-coronavirus-2019-6m-5y-vaccine-moderna.html | https://www.drugs.com/condition/covid-19.html | |||
sars-cov-2 mrna-1273 (booster only) vaccine | Covid 19 | hives , rash; dizziness , weakness, fast heartbeats; difficult breathing; swelling of your face, lips, tongue, or throat. Your vaccination provider may want to watch you for a short time after your shot, to make sure you don't have an allergic reaction. You will be treated quickly if you have a reaction right after you receive the vaccine. You should not receive this vaccine again if the first shot caused an allergic reaction. Your doctor or vaccination provider will determine if you can safely receive another COVID-19 vaccine. Not all possible side effects are known. Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine. Some people receiving this vaccine had inflammation of the heart muscle or the lining around the heart within a few days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if you have: chest pain; shortness of breath; or fast or pounding heartbeats or fluttering in your chest. Common side effects of COVID-19 (coronavirus 2019, 6y-11y) vaccine, Moderna may include: fever, chills; redness or a hardness and swelling where the shot was given; swelling or tenderness under your arm; nausea, vomiting; feeling tired; or headache, muscle pain, joint pain. | COVID-19 (coronavirus 2019, 6y-11y) vaccine, Moderna (KOE vid (koe ROE na vye rus) VAX een) Brand name: Moderna COVID-19 (Booster Only) Vaccine PF | Viral vaccines | 0% | Rx | N | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/mtm/covid-19-coronavirus-2019-6y-11y-vaccine-moderna.html | https://www.drugs.com/condition/covid-19.html | ||||
Spikevax | Covid 19 | Side effects that have been reported in clinical trials with Spikevax include: Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and fever In trial participants 18 through 64 years , the most commonly reported (≥10%) adverse reactions were pain at injection site (93.3%), fatigue (71.9%), headache (68.7%), myalgia (64.8%), chills (49.7%), arthralgia (48.6%), nausea/vomiting (25.7%), axillary swelling/tenderness (22.2%), fever (17.3%), swelling at the injection site (15.4%), and erythema at the injection site (10.5%). In trial participants 65 years of age and older , the most commonly reported (≥10%) adverse reactions were pain at injection site (88.3%), fatigue (64.8%), headache (53.3%), myalgia (51.8%), arthralgia (40.2%), chills (32.7%), nausea/vomiting (15.0%), swelling at the injection site (13.0%), and axillary swelling/tenderness (12.7%). Side effects that have been reported during post-authorization use of the vaccine include: Severe allergic reactions Myocarditis (inflammation of the heart muscle) Pericarditis (inflammation of the lining outside the heart) Fainting in association with injection of the vaccine These may not be all of the possible side effects of Spikevax. Ask your healthcare provider about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or https://vaers.hhs.gov. Spikevax side effects | COVID-19 Vaccine, mRNA | Viral vaccines | 0% | Rx | N | Paxlovid: https://www.drugs.com/paxlovid.html | molnupiravir: https://www.drugs.com/molnupiravir.html | remdesivir: https://www.drugs.com/mtm/remdesivir.html | Actemra: https://www.drugs.com/actemra.html | Lagevrio: https://www.drugs.com/cons/lagevrio.html | Pfizer-BioNTech COVID-19 Vaccine: https://www.drugs.com/pfizer-biontech-covid-19-vaccine.html | COVID-19: Prevention & Investigational Treatments Other names: 2019 Novel Coronavirus; 2019-nCoV; Coronavirus; Novel Coronavirus Pneumonia; SARS-CoV-2 Infection Updated - December 1, 2022. M Puckey BPharm What is COVID-19 COVID-19 Vaccines Treatments Investigational Vaccines What is COVID-19? COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020. The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal. For more information on COVID-19 Symptoms, Prevention and Risks COVID-19: Symptoms, Prevention and Risks Stay up to date on COVID-19 News COVID-19 News (Newsfeed from Drugs.com) FDA approved COVID-19 Vaccines Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA) last updated September 14, 2022. Vaccine platform: mRNA vaccine FDA approval date: August 23, 2021. Company: Pfizer Inc. and BioNTech. Comirnaty is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2.vaccine FDA approved as a 2-dose series to prevent coronavirus disease 2019 (COVID-19) in patients 12 years and older. Emergency Authorizatation: Primary series: third in primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Comirnaty contains the same vaccine as Pfizer-BioNTech COVID-19 Vaccine (monovalent). They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 virus. The FDA approved vaccine has the brand name Comirnaty, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Pfizer-BioNTech COVID-19 (monovalent). See below for more information on Pfizer-BioNTech COVID-19. Spikevax (mRNA-1273) last updated September 14,2022 Vaccine platform: mRNA vaccine FDA approval date: January 31, 2022. Company: Moderna Us, Inc. Spikevax vaccine is FDA approved vaccine to prevent coronavirus disease 2019 (COVID-19) in patients 18 years and older. It also has Emergency Use Authorisation for: A two-dose primary series to individuals 12 years through 17 years of age. A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose. Spikevax contains the same vaccine as Moderna COVID-19 Vaccine (monovalent) . The FDA approved vaccine has the brand name Spikevax, and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Moderna COVID-19 Vaccine, Bivalent is different from Spikevax and Moderna COVID-19 Vaccine (monovalent). Spikevax and Moderna COVID-19 Vaccine (monovalent) contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent contains two mRNA components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA) Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (updated September 8, 2022) Vaccine platform: mRNA vaccine Pfizer-BioNTech COVID-19 Vaccine (monovalent) is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Pfizer-BioNTech COVID-19 Vaccines are available under Emergency Use Authorization to protect against COVID-19. Company: Pfizer Inc. and BioNTech. Pfizer-BioNTech COVID-19 Vaccine (monovalent) Has emergency use authorization for: Three-dose primary series for individuals 6 months through 4 years of age. Two-dose primary series for individuals 5 years of age and older. Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. Booster dose of Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information. Pfizer-BioNTech COVID-19 Vaccine, Bivalent Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine. -Or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Pfizer-BioNTech COVID-19 (monovalent) contains the same vaccine as Comirnaty. Under an EUA approval the original vaccine has the name Pfizer-BioNTech COVID-19 (monovalent) and when it is used as a FDA approved medicine it has the brand name Comirnaty. Moderna COVID-19 Vaccine (mRNA-1273) last updated September 14, 2022. Vaccine platform: mRNA vaccine There are two different types of Moderna COVID-19 Vaccines, the original Moderna COVID-19 Vaccine which is monovalent and Moderna COVID-19 Vaccine, Bivalent. Moderna COVID-19 Vaccine (monovalent) contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2 and has emergency use authorization to prevent COVID-19 for: -Two-dose primary series for individuals 6 months of age and older. -Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 6 years of age and older as a single booster dose when given at least 2 months after either: -Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or -Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. When the original Moderna COVID-19 Vaccine is used as a FDA approved vaccine it has the brand name Spikevax , and when it is used under an Emergency Use Authorization (EUA) approval it has the name Moderna COVID-19 Vaccine (monovalent). Novavax COVID-19 Vaccine (NVX-CoV2373, Nuvaxovid, Covovax) (last updated October 20, 2022) Vaccine platform: Protein Subunit Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19 for individuals 12 years and older for the primary series. It has EUA as a booster dose for 18 years and older. Primary series: Two-dose primary series given three weeks apart for individuals 12 years and older. Booster dose: for individuals 18 years of age and older, at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: -for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and -for individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. Janssen - Johnson & Johnson COVID-19 Vaccine (Janssen COVID-19 Vaccine, Ad26.COV2-S) Vaccine platform: Non-Replicating Viral Vector Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA originally granted Emergency Use Authorization (EUA) for Janssen COVID-19 Vaccine on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2. On May 5, 2022, the FDA limited the use of Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Janssen COVID-19 Vaccine is given to patients who fit the criteria above, as a single-dose primary regime with a single booster dose which is given at least 2 months after other primary dose. Treatments Remdesivir ( Veklury ) The original FDA approval has now been expanded for treatment for COVID-19 patients who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds). Patients must have a positive SARS-CoV-2 viral test, be hospitalized, or non hospitalized patients must have mild-to-moderate COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor (an antiviral drug with broad-spectrum antiviral activity). Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Bamlanivimab is no longer authorized to be used as a monotherapy, to treat recently diagnosed COVID-19, after the FDA Emergency Use Authorization (EUA) was revoked on April 16, 2021. A combination therapy consisting of bamlanivimab and etesevimab (see below) is now available. Bamlanivimab and etesevimab has two separate Emergency Use Authorizations, one for the treatment of COVID-19 and another for post-exposure prophylaxis. Baricitinib ( Olumiant ) was FDA approved on May 10, 2022, to treat COVID-19 in patients 18 years and older who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib has an Emergency Use Authorization (EUA) received from the FDA on July 28, 2021 to treat COVID-19 in hospitalized pediatric patients 2 years to less than 18 years of age, who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Previously the EUA required that Baricitinib had to be used with remdesivir (Veklury), but this requirement has been revoked and it can now be used without remdesivir. Baricitinib is Janus kinase (JAK) inhibitor Baricitinib is marketed under the brand name Olumiant and is also an FDA approved medicine for the treatment of rheumatoid arthritis and adult patients with severe alopecia areata. Bebtelovimab has had the EUA revoked on November 30, 2022 because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab is a monoclonal antibody that was used for the treatment of specific patients who have COVID-19. It binds to the spike protein of the virus that causes COVID-19 and works against the omicron variant and the BA.2 omicron subvariant. The FDA originally granted Emergency Use Authorisation on February 11, 2022 for mild to moderate COVID-19 patients, who are 12 years of age and older, weighing at least 40 kilograms (88 pounds). They must have a positive COVID-19 test, and be at high risk of progression to severe COVID-19, including hospitalization or death, and unable to use alternative COVID-19 treatment options that are approved or authorized by the FDA, as they are not accessible or clinically appropriate. Bebtelovimab is not currently authorized for emergency use in any U.S. region at this time. Casirivimab and Imdevimab ( REGEN-COV, Ronapreve ) is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can only be used for patients who are infected with a COVID-19 variant that is susceptible to carsirivimab and imdevimab. It was originally granted Emergency Use Authorization by the FDA on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients. They must be at high risk for progression to severe COVID-19 and must be 12 years or older and weigh at least 40kg. The EUA was expanded so that REGEN-COV could be used as post-exposure prophylaxis in patients who are at high risk of severe COVID-19. Bamlanivimab and Etesevimab is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It is unlikely to be effective against the omicron COVID-19 variant. For this reason the EUA has been amended to state that it can be used only for patients who are infected with a COVID-19 variant that is susceptible to Bamlanivimab and Etesevimab. It was originally authorized to be used for COVID-19 by an Emergency Use Authorization (EUA) on 9 February 2021. An amendment to the EUA means that Bamlanivimab and Etesevimab can be used by neonates, pediatric patients and adults. It can be used as treatment of mild to moderate COVID-19 in patients who have a positive SARS-CoV-2 viral test and are at high risk of progressing to severe COVID-19, including hospitalization or death. Another amendment to the EUA means it can also be used as post-exposure prophylaxis (prevention) for people who have close contact with an someone who infected with SARS-CoV-2, or who are at high risk of exposure to a SARS-CoV-2 infected individual in an institutional settings such as a nursing homes, prisons etc. It can only be used as post-exposure prophylaxis by people who are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated, or who are not expected to develop an adequate immune response to a complete SARS-CoV-2 vaccination series. Evusheld (AZD7442, tixagevimab with cilgavimab) has been issued an Emergency Use Authorization (EUA) for pre-exposure prevention of COVID-19 in a specific group of patients. Tixagevimab and cilgavimab are long-acting monoclonal antibodies that block the virus’ attachment and entry into human cells by binding to different but overlapping sites on the virus’ spike protein. Evusheld can be used by patients who are 12 years and older and weigh at least 40 kg (approximately 88 pounds). Patients must not currently be infected with SARS-CoV-2 virus and not recently be exposed to the virus. They must also have a moderate to severely compromised immune system or be unable to be vaccinated against COVID-19 due to severe adverse reaction to available vaccines and/or the components of the vaccine. Evusheld may be effective for pre-exposure prevention of COVID-19 for six months and after this time a repeat dose may be given. Kineret (Anakinra ) is an interleukin-1 (IL-1) receptor antagonist that works to reduce acute severe lung inflammation. Kineret received Emergency Use Authorization (EUA) on November 8, 2022 to treat COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is also FDA approved to treat severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children. Molnupiravir (Lagevrio®, MK-4482) is Merck's oral antiviral capsule that is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. On December 23, 2021 the FDA issued an Emergency Use Authorization (EUA) for molnupiravir as a treatment of COVID-19 for patients 18 years and older, who are at risk developing severe illness, including hospitalization or death. Patients must have had positive SARS-CoV-2 viral test and they must also be unable to use alternative COVID-19 treatment options, due to being inaccessible or being clinically inappropriate. Molnupiravir should be started within 5 days of first COVID-19 symptoms. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) previously called PF-07321332: Nirmatrelvir is an oral SARS-CoV2-3CL protease inhibitor and ritonavir slows the metabolism of nirmatrelvir making nirmatrelvir more effective. On December 22, 2021 the FDA issued an Emergency Use Authorization for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19). Paxlovid can be taken by patients 12 years and older who weigh at least 40kg (88lb), who have had a positive Sars-CoV-2 test and are at a high risk of progressing to severe COVID-19, including hospitalization or death. Paxlovid should be started with 5 days of first COVID-19 symptoms. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions. Tocilizumab ( Actemra ) was granted Emergency Use Authorization on June 24, 2021 for the treatment of COVID-19 in hospitalized patients 2 years of age and older. They must be on a specified treatment regime in hospital. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions. Actemra is an interleukin-6 receptor antagonist. Investigational Treatments Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2. Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19. Early studies show an improvement of oxygenation and shortening of duration of oxygen-support, but more randomized controlled trials are warranted. Chloroquine phosphate: The older anti-malaria drug chloroquine was studied for effectiveness for COVID-19 but scientific data showed that chloroquine was unlikely to be effective for COVID-19 and also caused serious adverse effects. For these reasons on June 15, 2020 the FDA revoked the emergency use authorization (EUA) that had allowed chloroquine phosphate to be used for covid-19 patients. Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout. Convalescent Plasma: On 6 December, 2021, The World Health Organisation (WHO) updated the Therapeutics and COVID-19: living guidelines to recommend against the use of convalescent plasma for treatment of non-severe COVID-19 patients. It also recommended against using convalescent plasma for treatment of severe or critical COVID-19 patients, unless it is part of a clinical trial. On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. Studies have been completed with varying results, including the clinical trial SIREN-C3PO (NCT04355767) which showed convalescent plasma did not prevent disease progression of COVID-19. Another clinical trial NCT04338360 for hospitalized COVID-19 patients who were not receiving mechanical ventilation showed convalescent plasma transfusion with higher anti–SARS-CoV-2 IgG antibody levels lowered the risk of death compared to patients given convalescent plasma with lower levels of anti–SARS-CoV-2 IgG antibody levels. Dexamethasone: Results of the RECOVERY clinical trial (NCT04381936) showed that the cheap and widely available steroid dexamethasone reduced the 28-day mortality in hospitalized COVID-19 patients who were receiving respiratory support. The NIH COVID-19 treatment guideline lists dexamethasone as a treatment for hospitalized adult COVID-19 on oxygen support. The trial also showed that there was no benefit and in fact may possibly cause harm to COVID-19 patients who did not require oxygen. Favipiravir: (FabiFlu®) An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India. Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study . The current National Institutes of Health (NIH) COVID-19 treatment guidelines report that there is still insufficient evidence either for or against the use of fluvoxamine for the treatment of COVID-19. Hydroxychloroquine and azithromycin: The results of large, randomized controlled trials have failed to show a benefit using a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax) to treat COVID-19. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine and azithromycin for COVID-19. Hydroxychloroquine sulfate: Early in the COVID-19 pandemic, clinical trials studied the effect of the malaria drug hydroxychloroquine on COVID-19. The RECOVERY Trial (NCT04381936) was a large, randomized, controlled, open-label, platform trial comparing hydroxychloroquine treatment with usual standard care for COVID-19. The results indicated that patients treated with hydroxychloroquine did not have a lower level of deaths, and hydroxychloroquine did not provide other benefits in patients hospitalized with COVID-19. The emergency use authorization (EUA) that had been issued by the US FDA in March 2020 to allow the emergency use of hydroxychloroquine sulfate for the treatment of COVID-19 in certain hospitalized patients, was revoked on June 15, 2020. The National Institutes of Health (NIH) recommends against the use of hydroxychloroquine for COVID-19. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is used in the treatment of patients with lupus and arthritis. Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials. Lenzilumab is a GM-CSF (Granulocyte-macrophage colony-stimulating factor) neutralizing monoclonal antibody that has been studied to reduce the excessive inflammatory response that may occur in COVID-19. The phase 3 randomized, double-blind, placebo-controlled clinical trial called LIVE-AIR showed that early use of lenzilumab improved the chance of survival without the need for mechanical ventilation. Patients included in the study were hospitalized with COVID-19, required supplemental oxygen but had not yet progressed to invasive mechanical ventilation. Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area. Lopinavir and ritonavir: A drug combination of lopinavir with ritonavir has been studied as a treatment for COVID-19 in a number of large, randomized controlled trials, with the results showing a lack of clinical benefit. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial using lopinavir with ritonavir was discontinued after the data showed no decrease in mortality and similar lengths of hospital stay times. The NIH recommends against using lopinavir with ritonavir for hospitalized or non hospitalized patients. Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of hospitalized COVID-19 patients. Methylprednisolone is used in severe COVID-10 for its anti-inflammatory effect as it reduces the systemic inflammatory response that leads to lung injury and multisystem organ dysfunction. The NIH COVID-19 treatment guidelines indicate methylprednisolone can be used if dexamethasone is unavailable. Clinical trial results comparing treatment with dexamethasone to methylprednisolone in hospitalized patients with severe SARS-CoV2 Pneumonia showed both statistically significantly reduced recovery time and the need for transfer to intensive care. MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. In April 2021, Merck announced the discontinuation of the development of MK-7110 and instead focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine. MK-7110 works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Peginterferon Lambda: Clinical trials using Peginterferon Lambda to treat COVID-19 have been completed with varying results. In one trial on non hospitalized COVID-19 patients Peginterferon Lambda increased the proportion of patients with viral clearance by day 7, which could potentially prevent clinical deterioration. In another trial non hospitalized patients with uncomplicated COVID-19 did not have a significant reduction time in viral clearance or resolution of symptoms when compared with placebo. Zyesami ( RLF-100 : aviptadil ) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. Zyesami is currently enrolling patients for Phase 3 trials for hospitalized patients with life-threatening cases of COVID-19 and is part of the NIH Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership. It is a randomized, blinded, placebo-controlled clinical trial using Zyesami and the antiviral remdesivir (Veklury) both alone and in combination, to treat hospitalized COVID-19 patients who are experiencing Acute Respiratory Distress Syndrome (ARDS). Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) has been studied in critically ill COVID-19 patients who were in an intensive care unit (ICU). Results showed sarilumab improved patient outcomes including survival. The NIH COVID-19 treatment guidelines have sarilumab as an alternative if tofacitinib is not available, for treatment of hospitalized patients who require oxygen delivery through high-flow device or non invasive ventilation, or invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Sotrovimab (Xevudy) is no longer authorized to treat COVID-19 in the United States from 5 April 2022. The authorization was canceled as it is unlikely to be effective against Omicron BA.2, the most common variant of COVID-19 at this time. It is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells. Statins: Statins (HMG CoA reductase inhibitors): The family of cholesterol lowering medications are studied to determine whether they can reduce severity of COVID-19. Statins are thought to have an anti-inflammatory and immunomodulatory effect. Currently the recommendations for NIH is that if you are already taking a statin prescribed for your health condition, and then get COVID-19 you should continue taking your statin as prescribed. NIH does not recommend starting statins when you get COVID-19 if you have not been prescribed it for a health condition previously. STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients. Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19. Investigational Vaccines Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines. BBIBP-CorV (Vero cells) ( Also known as Sinopharm BIBP COVID-19 vaccine ) Vaccine platform: Inactivated On May 26, 2021 JAMA published a prespecified interim analysis of the Phase 3 trial which showed that the vaccine was 78.1% effective against symptomatic cases and 100% against severe cases. Convidecia ( Ad5-nCoV, Pakvac) Vaccine platform: Non Replicating Viral Vector CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. The company announced on February 25, 2021 interim analysis data of the phase III clinical trial of Convidecia shows it has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination. CoronaVac Vaccine Platform: Inactivated Sinovac Biotech Ltd. interim results of double-blind, randomised, placebo-controlled Phase 3 trials (NCT04582344) showed high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalisation (100%) at least 14 days after the second dose. COVAC1 (LNP-nCoVsaRNA) Vaccine platform: RNA Vaccine COVAC1 is a self-amplifying RNA (saRNA) that is lipid nanoparticle (LNP) encapsulated. Imperial College London announced in a Preprint with THE LANCET that Phase 1 dose-ranging trial that 87% of the 192 people had a strong antibody response to COVAC1. CVnCoV Vaccine platform: mRNA vaccine CureVac AG announced October 12, 2021 that CVnCoV will be withdrawn from regulatory review as CureVac will shift their focus of COVID-19 vaccine development to second-generation mRNA technology. Phase 2b/3 randomized, observer-blind, placebo-controlled studies had been initiated in December 2020 to assess the dose and efficacy of CVnCoV. GX-19 Vaccine platform: DNA vaccine Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea. INO-4800 Vaccine platform: DNA vaccine Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA. On November 09, 2021 the FDA lifted the partial clinical hold and therefore provided authorization to proceed for Phase 3 trial for its COVID-19 Vaccine Candidate, INO-4800. MRT5500 Vaccine platform: mRNA vaccine On September 28, 2021 Sanofi announced it will not pursue the development of MRT5500 and will instead focus on the final development stages of its recombinant COVID-19 vaccine in conjunction with GSK. Initial data from a Phase 1/2 study showed positive interim results with neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second injection. SCB-2019 (CpG 1018/Alum) Vaccine platform: Protein Subunit On Sep 22, 2021 Clover Pharmaceuticals announced that the randomized, double-blinded, placebo-controlled Phase2/3 SPECTRA Trial had met its primary and secondary endpoints. Efficacy against severe COVID-19 and hospitalization was 100%, and efficacy against moderate-to-severe COVID-19 was 84%. Efficacy against any severity of the Delta variant of COVID-19 was 79%. The SCB-2019 antigen is combined with CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Sputnik V (Gam-COVID-Vac) Vaccine platform: Non-Replicating Viral Vector On February 2, 2021 interim analysis of results of randomised controlled Phase 3 trial showed Gam-COVID-Vac had a 91.6% efficacy against COVID-19. It is a combined vector vaccine based on recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5) which are administered intramuscularly separately with a 21-day interval. V590 and V591 Vaccine platform: Replicating Viral Vector Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates. Vaxzevria (formerly AZD1222 , ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector Vaxzevria was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A randomised, double-blinded, placebo-controlled phase III study (D8110C00001) of Vaxzevria in the United States, Peru and Chile showed vaccine efficacy was 62.6% in patients who had had two doses within the recommended dosing interval. Vaxzevria is authorised for use in the European Union. VXA-CoV2-1 Vaccine platform: Non-Replicating Viral Vector On May 3, 2021 Vaxart announced VXA-CoV2-1 would move into Phase 2 studies. It is an oral tablet COVID-19 vaccine which targets both the spike protein (S) and nucleoprotein (N). More information Information for Clinicians on Therapeutic Options for COVID-19 Patients (CDC) COVID-19 Treatment Guidelines (NIH) Assessment of Evidence for COVID-19-Related Treatments (ASHP) "Solidarity" Clinical Trial for COVID-19 Treatments (WHO) Convalescent plasma therapy DRAFT Landscape of COVID-19 Candidate Vaccines (WHO) Fact Sheet: Explaining Operation Warp Speed (U.S. Department of Health & Human Services) References Centers for Disease Control and Prevention Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-ncov/index.html Accessed February 18, 2020 World Health Organization Coronavirus disease (COVID-19) outbreak https://www.who.int/emergencies/diseases/novel- coronavirus-2019 Accessed February 18, 2020 Shanghai officials reveal novel coronavirus transmission modes https://www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed February 18, 2020 Flu and HIV Drugs Show Efficacy Against Coronavirus https://www.the-scientist.com/news-opinion/flu-and-anti-hiv-drugs-show-efficacy-against-coronavirus-67052 Accessed February 18, 2020 The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application https://annals.org/aim/fullarticle/2762808/incubation-period-coronavirus-disease-2019-covid-19-from-publicly-reported Symptoms of Coronavirus https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html Accessed April30, 2020 Shanghai officials reveal novel coronavirus transmission modes www.chinadaily.com.cn/a/202002/08/WS5e3e7d97a310128217275fc3.html Accessed April30, 2020 How to Protect Yourself & Others https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fprepare%2Fprevention.html Tobacco-Use Disparity in Gene Expression of ACE2, the Receptor of 2019-nCov https://www.preprints.org/manuscript/202002.0051/v1 Accessed February 18, 2020 Reduce your risk of serious lung disease caused by corona virus by quitting smoking and vaping https://tobacco.ucsf.edu/reduce-your-risk-serious-lung-disease-caused-corona-virus-quitting-smoking-and-vaping Accessed April 20, 2020 Relationship between the ABO Blood Group and the COVID-19 Susceptibility https://www.medrxiv.org/content/10.1101/2020.03.11.20031096v2 Accessed March 16, 2020 People Who Are at Higher Risk for Severe Illness - Older Adults https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html Accessed April 20, 2020 Clinical trials for Baricitinib https://clinicaltrials.gov/ct2/results?cond=COVID&term=baricitinib&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for Bevacizumab https://clinicaltrials.gov/ct2/show/NCT04275414 Accessed April 30, 2020 Expert Consensus on Chloroquine Phosphate for the Treatment of Novel Coronavirus Pneumonia https://pubmed.ncbi.nlm.nih.gov/32075365/ Accessed April 30, 2020 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04322682 Accessed April 30, 2020 Carolina researchers playing a key role in the development of new COVID-19 treatment https://www.unc.edu/posts/2020/04/06/carolina-researchers-key-role-in-the-development-of-new-covid-19-treatment/ Accessed April 30, 2020 Favipiravir http://global.chinadaily.com.cn/a/202002/17/WS5e49efc2a310128217277fa3.html Accessed April 30, 2020 Fingolimod in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04280588 Accessed April 30, 2020 Hydroxychloroquine and Azitrhomy as a treatment for COVID-19 https://www.mediterranee-infection.com/hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19/ Accessed April 30, 2020 In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) https://pubmed.ncbi.nlm.nih.gov/32150618/ Accessed April 30, 2020 Lab experiments show anti-parasitic drug, Ivermectin, eliminates SARS-CoV-2 in cells in 48 hours https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours Accessed April 30, 2020 Bangkok Post https://www.bangkokpost.com/thailand/general/1860329/woman-74-recovers-from-virus-after-thai-cocktail Accessed April 30, 2020 A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 Accessed April 30, 2020 Efficacy and Safety of Corticosteroids in COVID-19 https://clinicaltrials.gov/ct2/show/NCT04273321 Accessed April 30, 2020 Clinical trials for tocilizumab in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=tocilizumab&cntry=&state=&city=&dist= Accessed April 30, 2020 Clinical trials for umifenovir in COVID-19 https://clinicaltrials.gov/ct2/results?cond=COVID&term=umifenovir&cntry=&state=&city=&dist= Accessed April 30, 2020 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection (COVID-19) https://clinicaltrials.gov/ct2/show/NCT04283461 Accessed April 30, 2020 CSIRO begins testing Covid-19 vaccineshttps://www.csiro.au/en/News/News-releases/2020/CSIRO-begins-testing-Covid-19-vaccines Accessed April 30, 2020 MIGAL’s Coronavirus Vaccine Project https://www.migal.org.il/en/node/7010 Accessed April 30, 2020 Efficacy and tolerability of bevacizumab in patients with severe Covid-19: https://www.nature.com/articles/s41467-021-21085-8 | null | null | https://www.drugs.com/spikevax.html | https://www.drugs.com/condition/covid-19.html | |||
Zoloft | Depression | skin rash or hives (with or without fever or joint pain); difficulty breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Zoloft may cause serious side effects. Call your doctor at once if you have: unusual bleeding or bruising; a seizure; vision changes, eye pain , redness, or swelling; low blood sodium - headache , confusion, problems with thinking or memory, weakness, feeling unsteady; or manic episodes - racing thoughts, increased energy, unusual risk-taking behavior, extreme happiness, being irritable or talkative. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate , muscle stiffness, twitching, loss of coordination, nausea , vomiting , or diarrhea . Sertraline can affect growth in children. Your child's height and weight may be checked often. Common side effects of Zoloft may include: indigestion ; nausea; diarrhea; loss of appetite; loose stool; increased sweating; tremors; or sexual problems. | sertraline | Selective serotonin reuptake inhibitors | 78% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 6.8 | 612 | https://www.drugs.com/zoloft.html | https://www.drugs.com/condition/depression.html | ||
Prozac | Depression | mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Prozac may cause serious side effects. Call your doctor at once if you have: blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); low levels of sodium in the body - headache , confusion, slurred speech, severe weakness, vomiting , loss of coordination, feeling unsteady; or severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate , muscle stiffness, twitching, loss of coordination, nausea , vomiting, or diarrhea . Common side effects of Prozac may include: sleep problems ( insomnia ), strange dreams; headache, dizziness, drowsiness, vision changes; tremors or shaking, feeling anxious or nervous; pain, weakness, yawning, tired feeling; upset stomach , loss of appetite, nausea, vomiting, diarrhea; dry mouth, sweating, hot flashes ; changes in weight or appetite; stuffy nose, sinus pain, sore throat, flu symptoms; or decreased sex drive, impotence , or difficulty having an orgasm. | fluoxetine | Selective serotonin reuptake inhibitors | Prozac Weekly | 60% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 7 | 423 | https://www.drugs.com/prozac.html | https://www.drugs.com/condition/depression.html | |
fluoxetine | Depression | mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Fluoxetine may cause serious side effects. Call your doctor at once if you have: blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); low levels of sodium in the body - headache , confusion, slurred speech, severe weakness, vomiting , loss of coordination, feeling unsteady; or severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate , muscle stiffness, twitching, loss of coordination, nausea , vomiting, or diarrhea . Common fluoxetine side effects may include: sleep problems ( insomnia ), strange dreams; headache, dizziness, drowsiness, vision changes; tremors or shaking, feeling anxious or nervous; pain, weakness, yawning, tired feeling; upset stomach , loss of appetite, nausea, vomiting, diarrhea; dry mouth, sweating, hot flashes ; changes in weight or appetite; stuffy nose, sinus pain, sore throat, flu symptoms; or decreased sex drive, impotence , or difficulty having an orgasm. | fluoxetine | Selective serotonin reuptake inhibitors | Prozac, Sarafem, Rapiflux, Selfemra | 59% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 7 | 699 | https://www.drugs.com/fluoxetine.html | https://www.drugs.com/condition/depression.html | |
Wellbutrin XL | Depression | mood or behavior changes, anxiety , depression, panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Wellbutrin XL may cause serious side effects. Call your doctor at once if you have: a seizure (convulsions); confusion, unusual changes in mood or behavior; blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; fast or irregular heartbeats; or a manic episode--racing thoughts, increased energy, reckless behavior, feeling extremely happy or irritable, talking more than usual, severe problems with sleep. Common side effects of Wellbutrin XL may include: dry mouth, sore throat, stuffy nose; ringing in the ears; blurred vision; nausea , vomiting , stomach pain, loss of appetite, constipation ; sleep problems ( insomnia ); tremors, sweating, feeling anxious or nervous; fast heartbeats; confusion, agitation , hostility; rash; weight loss ; increased urination; headache , dizziness ; or muscle or joint pain. | bupropion | Miscellaneous antidepressants | Aplenzin, Forfivo XL, Wellbutrin SR | 59% | Rx | C | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | bupropion: https://www.drugs.com/bupropion.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Prozac: https://www.drugs.com/prozac.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 7.4 | 301 | https://www.drugs.com/mtm/wellbutrin-xl.html | https://www.drugs.com/condition/depression.html |
Celexa | Depression | hives , rash, blisters; fever, joint pain; difficult breathing; swelling of your face, lips, tongue, or throat. Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself. Call your doctor at once if you have: a light-headed feeling, like you might pass out; blurred vision, eye pain or redness, seeing halos around lights; fast or pounding heartbeats, pain or fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); a seizure; manic episodes - racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative; severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors; or low blood sodium - headache , confusion, problems with thinking or memory, weakness, feeling unsteady. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate , muscle stiffness, twitching, loss of coordination, nausea , vomiting , or diarrhea . Common Celexa side effects may include: sexual problems; dizziness, drowsiness; dry mouth, thirst, increased sweating or urination; loss of appetite, nausea, diarrhea, constipation ; feeling anxious, agitated, or shaky; feeling weak or tired; sleep problems ( insomnia ); yawning; increased muscle movement; nosebleeds , heavy menstrual bleeding ; or cold symptoms such as stuffy nose, sneezing, sore throat . | citalopram | Selective serotonin reuptake inhibitors | 51% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 7.2 | 364 | https://www.drugs.com/celexa.html | https://www.drugs.com/condition/depression.html | ||
Trintellix | Depression | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Call your doctor at once if you have: racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual; vision changes, eye pain , eye redness or swelling; easy bruising, unusual bleeding, coughing up blood ; or low sodium level (may be more likely to occur in older adults - confusion, memory problems, hallucinations, slurred speech, severe weakness, feeling unsteady. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation , hallucinations, fever, sweating, shivering, fast heart rate , muscle stiffness, twitching, loss of coordination, nausea , vomiting , or diarrhea . Common Trintellix side effects may include: nausea; constipation ; or vomiting. | vortioxetine | Miscellaneous antidepressants | 43% | Rx | C | N | X | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Prozac: https://www.drugs.com/prozac.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 6 | 603 | https://www.drugs.com/trintellix.html | https://www.drugs.com/condition/depression.html | |
Rexulti | Depression | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. High doses or long-term use of Rexulti can cause a serious movement disorder that may not be reversible. The longer you use this medicine, the more likely you are to develop this disorder, especially if you are a diabetic or an older adult. Call your doctor at once if you have: uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); trouble swallowing; feelings of warmth, intolerance to heat; a seizure (convulsions); a light-headed feeling, like you might pass out; high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; low white blood cell counts - fever, mouth sores, skin sores, sore throat , cough, trouble breathing; severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors; or signs of a blood clot - sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg. You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs. Common Rexulti side effects may include: weight gain; or feeling restless or being unable to sit still. | brexpiprazole | Atypical antipsychotics | 34% | Rx | N | X | Latuda: https://www.drugs.com/latuda.html | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | quetiapine: https://www.drugs.com/quetiapine.html | Zoloft: https://www.drugs.com/zoloft.html | Abilify: https://www.drugs.com/abilify.html | Cymbalta: https://www.drugs.com/cymbalta.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 6.9 | 133 | https://www.drugs.com/rexulti.html | https://www.drugs.com/condition/depression.html | ||
vortioxetine | Depression | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Vortioxetine may cause serious side effects. Call your doctor at once if you have: racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual; vision changes, eye pain , eye redness or swelling; easy bruising, unusual bleeding, coughing up blood ; or low sodium level (may be more likely to occur in older adults--confusion, memory problems, hallucinations, slurred speech, severe weakness, feeling unsteady. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation , hallucinations, fever, sweating, shivering, fast heart rate , muscle stiffness, twitching, loss of coordination, nausea , vomiting , or diarrhea . Common side effects of vortioxetine may include: nausea; constipation ; or vomiting. | vortioxetine | Miscellaneous antidepressants | Trintellix | 33% | Rx | C | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Prozac: https://www.drugs.com/prozac.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 5.9 | 885 | https://www.drugs.com/mtm/vortioxetine.html | https://www.drugs.com/condition/depression.html |
brexpiprazole | Depression | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. High doses or long-term use of brexpiprazole can cause a serious movement disorder that may not be reversible. The longer you use brexpiprazole, the more likely you are to develop this disorder, especially if you are a diabetic or an older adult. Brexpiprazole may cause serious side effects. Call your doctor at once if you have: uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); trouble swallowing; feelings of warmth, intolerance to heat; a seizure (convulsions); a light-headed feeling, like you might pass out; high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; low white blood cell counts--fever, mouth sores, skin sores, sore throat , cough, trouble breathing; severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors; or signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg. You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs. Common side effects of brexpiprazole may include: weight gain; or feeling restless or being unable to sit still. | brexpiprazole | Atypical antipsychotics | Rexulti | 31% | Rx | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 7 | 146 | https://www.drugs.com/mtm/brexpiprazole.html | https://www.drugs.com/condition/depression.html | ||
Pristiq | Depression | skin rash or hives ; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself. Call your doctor at once if you have: a seizure; easy bruising or bleeding ( nosebleeds , bleeding gums), blood in your urine or stools, coughing up blood ; blurred vision, eye pain or swelling, or seeing halos around lights; cough, chest discomfort, trouble breathing; or low blood sodium - headache, confusion, problems with thinking or memory, weakness, feeling unsteady. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea. Common Pristiq side effects may include: dizziness , drowsiness, anxiety; increased sweating; nausea, decreased appetite, constipation ; sleep problems ( insomnia ); or decreased sex drive, impotence , or difficulty having an orgasm. | desvenlafaxine | Serotonin-norepinephrine reuptake inhibitors | 28% | Rx | C | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Prozac: https://www.drugs.com/prozac.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 6.9 | 773 | https://www.drugs.com/pristiq.html | https://www.drugs.com/condition/depression.html | |
Effexor | Depression | null | venlafaxine hydrochloride | Serotonin-norepinephrine reuptake inhibitors | 24% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 5.5 | 341 | https://www.drugs.com/pro/effexor.html | https://www.drugs.com/condition/depression.html | ||
Remeron | Depression | mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Call your doctor at once if you have: racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual; blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; a light-headed feeling, like you might pass out; severe rash, blisters, or swelling on the palms of your hands or the soles of your feet; a seizure; low white blood cell counts - fever, chills, sore throat, cough, sores in your mouth or nose, flu-like symptoms, trouble breathing; or low sodium level - headache , confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea , vomiting, or diarrhea . Common Remeron side effects include: drowsiness, dizziness; increased appetite; or weight gain. | mirtazapine | Tetracyclic antidepressants | Remeron SolTab | 19% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 7 | 168 | https://www.drugs.com/remeron.html | https://www.drugs.com/condition/depression.html | |
Wellbutrin SR | Depression | mood or behavior changes, anxiety , depression, panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Wellbutrin SR may cause serious side effects. Call your doctor at once if you have: a seizure (convulsions); confusion, unusual changes in mood or behavior; blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; fast or irregular heartbeats; or a manic episode--racing thoughts, increased energy, reckless behavior, feeling extremely happy or irritable, talking more than usual, severe problems with sleep. Common side effects of Wellbutrin SR may include: dry mouth, sore throat, stuffy nose; ringing in the ears; blurred vision; nausea , vomiting , stomach pain, loss of appetite, constipation ; sleep problems ( insomnia ); tremors, sweating, feeling anxious or nervous; fast heartbeats; confusion, agitation , hostility; rash; weight loss ; increased urination; headache , dizziness ; or muscle or joint pain. | bupropion | Miscellaneous antidepressants | Aplenzin, Forfivo XL, Wellbutrin XL | 19% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 6.8 | 104 | https://www.drugs.com/mtm/wellbutrin-sr.html | https://www.drugs.com/condition/depression.html | |
amitriptyline | Depression | hives ; difficulty breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Call your doctor at once if you have: signs of a blood clot - sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg; unusual thoughts or behavior; a light-headed feeling, like you might pass out; chest pain or pressure, pain spreading to your jaw or shoulder, nausea , sweating; pounding heartbeats or fluttering in your chest; confusion, hallucinations; a seizure (convulsions); painful or difficult urination; severe constipation ; easy bruising, unusual bleeding; or fever, chills, sore throat , mouth sores. Common amitriptyline side effects may include: constipation, diarrhea ; nausea, vomiting , upset stomach ; mouth pain, unusual taste, black tongue; appetite or weight changes; urinating less than usual; itching or rash; breast swelling (in men or women); or decreased sex drive, impotence , or difficulty having an orgasm. | amitriptyline | Tricyclic antidepressants | Elavil, Vanatrip | 17% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 8.1 | 126 | https://www.drugs.com/amitriptyline.html | https://www.drugs.com/condition/depression.html | |
Viibryd | Depression | skin rash or hives ; difficulty breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Call your doctor at once if you have: a seizure (convulsions); blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; easy bruising, unusual bleeding; racing thoughts, unusual risk-taking behavior, decreased inhibitions, feelings of extreme happiness or sadness; or low levels of sodium in the body - headache , confusion, slurred speech, severe weakness, loss of coordination, feeling unsteady. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate , muscle stiffness, twitching, loss of coordination, nausea , vomiting , or diarrhea . Common Viibryd side effects may include: nausea, vomiting; diarrhea; or sleep problems ( insomnia ). | vilazodone | Miscellaneous antidepressants | 17% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 6 | 586 | https://www.drugs.com/viibryd.html | https://www.drugs.com/condition/depression.html | ||
Deplin | Depression | hives ; difficulty breathing; swelling of your face, lips, tongue, or throat. Less serious side effects may occur, and you may have none at all. | l-methylfolate | Vitamins | L-Methylfolate Formula, XaQuil XR | 8% | Rx | N | N | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 7.3 | 92 | https://www.drugs.com/mtm/deplin.html | https://www.drugs.com/condition/depression.html | ||
nortriptyline | Depression | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Call your doctor at once if you have: blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; restless muscle movements in your eyes, tongue, jaw, or neck; a light-headed feeling, like you might pass out; seizure (convulsions); new or worsening chest pain, pounding heartbeats or fluttering in your chest; sudden numbness or weakness, problems with vision, speech, or balance; fever, sore throat , easy bruising, unusual bleeding; painful or difficult urination; or jaundice (yellowing of the skin or eyes). Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate , muscle stiffness, twitching, loss of coordination, nausea , vomiting, or diarrhea . Common nortriptyline side effects may include: increased blood pressure; numbness or tingling in your hands or feet; dry mouth, nausea, vomiting, loss of appetite; blurred vision; rash, itching; or breast swelling (in men or women). | nortriptyline | Tricyclic antidepressants | Pamelor | 8% | Rx | N | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 6.3 | 60 | https://www.drugs.com/nortriptyline.html | https://www.drugs.com/condition/depression.html | |
Desyrel | Depression | hives ; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Desyrel and call your doctor at once if you have a penis erection that is painful or lasts 6 hours or longer. This is a medical emergency and could lead to a serious condition that must be corrected with surgery. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Desyrel may cause serious side effects. Call your doctor at once if you have: fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); slow heartbeats; unusual thoughts or behavior; easy bruising, unusual bleeding; or low levels of sodium in the body-- headache , confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate , muscle stiffness, twitching, loss of coordination, nausea , vomiting, or diarrhea . Common side effects of Desyrel may include: drowsiness, dizziness, tiredness; swelling; weight loss ; blurred vision; diarrhea, constipation ; or stuffy nose. | trazodone | Phenylpiperazine antidepressants | 7% | Rx | C | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | hydroxyzine: https://www.drugs.com/hydroxyzine.html | citalopram: https://www.drugs.com/citalopram.html | lorazepam: https://www.drugs.com/lorazepam.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Prozac: https://www.drugs.com/prozac.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 7 | 4 | https://www.drugs.com/mtm/desyrel.html | https://www.drugs.com/condition/depression.html | |
Forfivo XL | Depression | Forfivo XL can cause serious side effects, including: See Important information about Forfivo XL The most common side effects of Forfivo XL include: dry mouth nausea trouble sleeping dizziness sore throat stomach pain agitation anxiety shakiness fast heart beat sweating ringing in the ears muscle pain anorexia urinating more often than normal for you rash If you have nausea, take your medicine with food. If you have trouble sleeping, do not take your medicine too close to bedtime. Tell your healthcare provider right away about any side effects that bother you. These are not all the side effects of Forfivo XL. For a complete list, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Forfivo XL side effects | bupropion hydrochloride | Miscellaneous antidepressants | 7% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 10 | 1 | https://www.drugs.com/forfivo-xl.html | https://www.drugs.com/condition/depression.html | ||
Budeprion SR | Depression | Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: More common Anxiety dry mouth hyperventilation irregular heartbeats irritability restlessness shaking trouble sleeping Less common Buzzing or ringing in the ears headache (severe) skin rash, hives, or itching Rare Confusion fainting false beliefs that cannot be changed by facts having extreme distrust of people seeing, hearing, or feeling things that are not there seizures trouble concentrating Incidence not known Actions that are out of control anger assaulting or attacking others being aggressive or impulsive chest pain or discomfort fast or pounding heartbeat force inability to sit still need to keep moving sweating talking, feeling, or acting with excitement Symptoms of overdose Lightheadedness, dizziness, or fainting loss of consciousness slow or irregular heartbeat unusual tiredness Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: More common Constipation decrease in appetite dizziness increased sweating stomach pain trembling unusual weight loss Less common Blurred vision change in sense of taste drowsiness frequent need to urinate sore throat unusual feeling of well-being Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Budeprion SR side effects | bupropion (oral route) | Miscellaneous antidepressants | 6% | Rx | C | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Prozac: https://www.drugs.com/prozac.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 7.6 | 12 | https://www.drugs.com/cons/budeprion-sr.html | https://www.drugs.com/condition/depression.html | |
Aplenzin | Depression | (hives, itching, fever, swollen glands, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling). Report any new or worsening symptoms to your doctor , such as: mood or behavior changes, anxiety, depression, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Call your doctor at once if you have: a seizure (convulsions); confusion, unusual changes in mood or behavior; blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; fast or irregular heartbeats; or a manic episode - racing thoughts, increased energy, reckless behavior, feeling extremely happy or irritable, talking more than usual, severe problems with sleep. Common Aplenzin side effects may include: dry mouth, sore throat, stuffy nose; ringing in the ears; blurred vision; nausea, vomiting, stomach pain, loss of appetite, constipation; sleep problems (insomnia); tremors, sweating, feeling anxious or nervous; fast heartbeats; confusion, agitation, hostility; rash; weight loss; increased urination; headache, dizziness; or muscle or joint pain. | bupropion hydrobromide extended-release tablets | Miscellaneous antidepressants | 5% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 6.5 | 14 | https://www.drugs.com/aplenzin.html | https://www.drugs.com/condition/depression.html | ||
Desyrel Dividose | Depression | Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: More common Blurred vision confusion dizziness dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position lightheadedness sweating unusual tiredness or weakness Less common Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings confusion about identity, place, and time decreased concentration fainting general feeling of discomfort or illness headache lack of coordination muscle tremors nervousness pounding in the ears shortness of breath slow or fast heartbeat swelling Rare Skin rash unusual excitement Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: More common Dry mouth (usually mild) muscle or bone pain trouble sleeping trouble with remembering unpleasant taste Less common Constipation continuing ringing or buzzing or other unexplained noise in the ears diarrhea hearing loss muscle aches or pains weight loss Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Desyrel Dividose side effects | trazodone (oral route) | Phenylpiperazine antidepressants | 5% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | null | null | https://www.drugs.com/cons/desyrel-dividose-oral.html | https://www.drugs.com/condition/depression.html | ||
Fetzima | Depression | skin rash or hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself. Call your doctor at once if you have: blurred vision, tunnel vision, eye pain or swelling, eye redness ; painful or difficult urination; easy bruising, unusual bleeding, purple or red spots under your skin; pounding heartbeats or fluttering in your chest; seizure (convulsions); manic episodes - racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative; or low sodium level - headache , confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady. Serious side effects may be more likely in older adults. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea. Common Fetzima side effects may include: nausea, vomiting, constipation ; irregular heartbeats; sweating; or decreased sex drive, impotence , or difficulty having an orgasm. | levomilnacipran | Serotonin-norepinephrine reuptake inhibitors | 5% | Rx | C | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Prozac: https://www.drugs.com/prozac.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 4.7 | 91 | https://www.drugs.com/fetzima.html | https://www.drugs.com/condition/depression.html | |
Irenka | Depression | pounding heartbeats or fluttering in your chest; a light-headed feeling, like you might pass out; easy bruising, unusual bleeding; vision changes; painful or difficult urination; liver problems--right-sided upper stomach pain, itching, dark urine, jaundice (yellowing of the skin or eyes); low blood sodium-- headache , confusion, problems with thinking or memory, weakness, feeling unsteady; or manic episodes--racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate , muscle stiffness, twitching, loss of coordination, nausea , vomiting, or diarrhea . Common side effects of Irenka may include: drowsiness; nausea, constipation , loss of appetite; dry mouth; or increased sweating. | duloxetine | Serotonin-norepinephrine reuptake inhibitors | Cymbalta, Drizalma Sprinkle | 4% | Rx | C | N | X | Trintellix: https://www.drugs.com/trintellix.html | Buprenex: https://www.drugs.com/buprenex.html | Subutex: https://www.drugs.com/subutex.html | aspirin: https://www.drugs.com/aspirin.html | sertraline: https://www.drugs.com/sertraline.html | ibuprofen: https://www.drugs.com/ibuprofen.html | tramadol: https://www.drugs.com/tramadol.html | trazodone: https://www.drugs.com/trazodone.html | escitalopram: https://www.drugs.com/escitalopram.html | duloxetine: https://www.drugs.com/duloxetine.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | null | null | https://www.drugs.com/mtm/irenka.html | https://www.drugs.com/condition/depression.html |
fluvoxamine | Depression | skin rash , blisters, or hives ; fever, joint pain; difficult breathing; swelling of your face, lips, tongue, or throat. Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself. Call your doctor at once if you have; anxiety, racing thoughts, risk-taking behavior, sleep problems ( insomnia ), feelings of extreme happiness or irritability; blurred vision, eye pain or redness, seeing halos around lights; a seizure; changes in weight or appetite; easy bruising or unusual bleeding; or low blood sodium-- headache , confusion, problems with thinking or memory, weakness, feeling unsteady. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate , muscle stiffness, twitching, loss of coordination, nausea , vomiting, or diarrhea Fluvoxamine can affect growth in children. Your child's height and weight should be checked often. Common side effects of fluvoxamine may include: drowsiness, dizziness , weakness; anxiety, depression, agitation, trouble sleeping; shaking, increased muscle movements; upset stomach , gas, loss of appetite; nausea, vomiting, diarrhea; dry mouth, yawning, sore throat ; muscle pain; sweating, rash; heavy menstrual periods; or sexual problems. | fluvoxamine | Selective serotonin reuptake inhibitors | Luvox, Luvox CR | 3% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 6.6 | 35 | https://www.drugs.com/mtm/fluvoxamine.html | https://www.drugs.com/condition/depression.html | |
l-methylfolate | Depression | hives ; difficulty breathing; swelling of your face, lips, tongue, or throat. Less serious side effects may occur, and you may have none at all. | l-methylfolate | Vitamins | Deplin, L-Methylfolate Formula, XaQuil XR, Duleek-DP, L-Methylfolate Forte, Elfolate, Denovo | 3% | Rx | N | N | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | folic acid: https://www.drugs.com/folic_acid.html | multivitamin: https://www.drugs.com/mtm/multivitamins.html | Deplin: https://www.drugs.com/mtm/deplin.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 7.6 | 136 | https://www.drugs.com/mtm/l-methylfolate.html | https://www.drugs.com/condition/depression.html | |
Parnate | Depression | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Parnate may cause serious side effects. Call your doctor at once if you have: dilated pupils, vision problems, sensitivity to light; sudden and severe headache, neck pain or stiffness; numbness or weakness, problems with vision or speech; fast or pounding heartbeats; fever, cold sweat, nausea, vomiting; a light-headed feeling, like you might pass out; a seizure; manic episodes--racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative; high levels of serotonin in the body--agitation, hallucinations, sweating, shivering, muscle stiffness, twitching, loss of coordination, vomiting, diarrhea ; or liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes). Serious side effects may be more likely in older adults. Common side effects of Parnate may include: dizziness , drowsiness; constipation ; dry mouth, blurred vision; trouble sleeping; headache; or feeling shaky or excited. | tranylcypromine | Monoamine oxidase inhibitors | 3% | Rx | N | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 8.5 | 89 | https://www.drugs.com/mtm/parnate.html | https://www.drugs.com/condition/depression.html | ||
Remeron SolTab | Depression | mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Remeron SolTab may cause serious side effects. Call your doctor at once if you have: racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual; blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; a light-headed feeling, like you might pass out; severe rash, blisters, or swelling on the palms of your hands or the soles of your feet; a seizure; low white blood cell counts--fever, chills, sore throat, cough, sores in your mouth or nose, flu-like symptoms, trouble breathing; or low sodium level -- headache , confusion, slurred speech, severe weakness, vomiting , loss of coordination, feeling unsteady. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea , vomiting, or diarrhea . Common side effects include: drowsiness, dizziness ; increased appetite; or weight gain. | mirtazapine | Tetracyclic antidepressants | Remeron | 3% | Rx | C | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Prozac: https://www.drugs.com/prozac.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 8 | 6 | https://www.drugs.com/mtm/remeron-soltab.html | https://www.drugs.com/condition/depression.html |
amoxapine | Depression | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Amoxapine may cause serious side effects. Call your doctor at once if you have: skin rash , fever; uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); pounding heartbeats or fluttering in your chest; chest pain or pressure, pain spreading to your jaw or shoulder; sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance; or severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out. Common side effects of amoxapine may include: drowsiness; constipation ; dry mouth; or blurred vision. | amoxapine | Tricyclic antidepressants | Asendin | 2% | Rx | C | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 9.6 | 6 | https://www.drugs.com/mtm/amoxapine.html | https://www.drugs.com/condition/depression.html |
Aventyl Hydrochloride | Depression | Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: Incidence not known Agitation blurred vision burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings chest pain or discomfort clay-colored stools cold sweats confusion about identity, place, and time false beliefs that cannot be changed by facts continuing ringing or buzzing or other unexplained noise in the ears decreased urination deep or fast breathing with dizziness depression difficulty in passing urine (dribbling) difficulty with speaking dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position double vision fast, pounding, or irregular heartbeat or pulse feeling of warmth feeling, seeing, or hearing things that are not there feeling that others are watching you or controlling your behavior feeling that others can hear your thoughts general feeling of tiredness or weakness hives or welts hostility inability to move the arms, legs, or facial muscles inability to speak irritability labored breathing, especially at night loss of balance control loss of consciousness lower back or side pain mood or mental changes muscle spasm, trembling, jerking, or stiffness nightmares numbness of the feet, hands, and around mouth pain or discomfort in the arms, jaw, back, or neck painful or difficult urination panic perspiration pinpoint red or purple spots on the skin redness of the face, neck, arms, and occasionally, upper chest restlessness seizures slurred speech sores, ulcers, or white spots on the lips or in the mouth stiffness of the limbs stomach pain sweating swelling of the face, ankles, legs, or hands swollen, painful, or tender lymph glands on side of face or neck talking, feeling, and acting with excitement trouble sleeping twisting movements of the body uncontrolled movements, especially of the face, neck, and back unexplained fainting weakness in the arms, hands, legs, or feet Symptoms of overdose Chest pain or tightness clumsiness cold, clammy skin confusion decreased awareness or responsiveness decreased urine output dilated neck veins extreme tiredness or weakness fainting fast, slow, or irregular heartbeat fast, weak pulse increased or excessive unconscious or jerking movements irregular breathing lightheadedness loss of consciousness low body temperature muscle stiffness, weakness, or tightness restlessness seeing things that are not there seizures severe sleepiness shivering swelling of the face, fingers, feet, or lower legs troubled breathing weak or feeble pulse weight gain Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Incidence not known Bigger, dilated, or enlarged pupils (black part of the eye) black tongue decreased interest in sexual ability or desire difficulty having a bowel movement enlargement of the breast hair loss or thinning of the hair heartburn increase in sexual ability or desire increased sensitivity of the eyes or skin to light pain or discomfort in the chest, upper stomach, or throat peculiar taste severe sunburn small red or purple spots on the skin swelling of the testicles swelling or inflammation of the mouth waking to urinate at night Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Aventyl Hydrochloride side effects | nortriptyline (oral route) | Tricyclic antidepressants | 2% | Rx | N | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | amitriptyline: https://www.drugs.com/amitriptyline.html | citalopram: https://www.drugs.com/citalopram.html | venlafaxine: https://www.drugs.com/venlafaxine.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | nortriptyline: https://www.drugs.com/nortriptyline.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 9 | 1 | https://www.drugs.com/cons/aventyl.html | https://www.drugs.com/condition/depression.html | |
clomipramine | Depression | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash , fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Clomipramine may cause serious side effects. Call your doctor at once if you have: low sodium level -- headache , confusion, slurred speech, severe weakness, vomiting , loss of coordination, feeling unsteady; blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; confusion, extreme fear, thoughts of hurting yourself; pain or burning when you urinate; or a seizure (convulsions). Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation , hallucinations, fever, sweating, shivering, fast heart rate , muscle stiffness, twitching, loss of coordination, nausea , vomiting, or diarrhea . Common side effects of clomipramine may include: feeling dizzy, drowsy, tired, or nervous; tremors, jerking muscle movements; sweating; changes in appetite or weight; urination problems; vision changes; or decreased sex drive, impotence , or difficulty having an orgasm. | clomipramine | Tricyclic antidepressants | Anafranil | 2% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 6.8 | 42 | https://www.drugs.com/mtm/clomipramine.html | https://www.drugs.com/condition/depression.html | |
Emsam | Depression | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Remove the skin patch and get emergency medical help if you have any of these signs of dangerously high blood pressure : sudden and severe headache, confusion, vision problems, chest pain , pounding in your neck or ears, sweating, vomiting , neck stiffness, fast or slow heartbeats, or dilated pupils. Call your doctor at once if you have: sudden numbness or weakness (especially on one side of the body); problems with speech or balance; manic episodes--racing thoughts, increased energy, unusual risk-taking behavior, extreme happiness, being irritable or talkative. Remove the patch and seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation , hallucinations, fever, sweating, shivering, fast heart rate , muscle stiffness, twitching, loss of coordination, nausea , vomiting, or diarrhea . Common Emsam side effects may include: redness or itching where the patch is worn; headache; diarrhea, upset stomach , dry mouth; sleep problems ( insomnia ); rash; or sinus pain or stuffy nose. | selegiline (transdermal) | Dopaminergic antiparkinsonism agents, Monoamine oxidase inhibitors | 2% | Rx | C | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Prozac: https://www.drugs.com/prozac.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 7.9 | 32 | https://www.drugs.com/emsam.html | https://www.drugs.com/condition/depression.html | |
ketamine | Depression | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers if you have hallucinations or unusual thoughts while waking up from anesthesia. Ketamine may cause serious side effects. Call your doctor at once if you have: painful or difficult urination, increased urination, loss of bladder control, blood in your urine; a light-headed feeling, like you might pass out; slow heart rate , weak or shallow breathing; or jerky muscle movements that may look like convulsions. Common side effects of ketamine may include: confusion; or dream-like feeling. | ketamine | General anesthetics | Ketalar | 2% | Rx | N | 3 | X | fentanyl: https://www.drugs.com/fentanyl.html | lidocaine: https://www.drugs.com/mtm/lidocaine-injection.html | propofol: https://www.drugs.com/propofol.html | hyoscyamine: https://www.drugs.com/mtm/hyoscyamine.html | glycopyrrolate: https://www.drugs.com/mtm/glycopyrrolate.html | Levsin: https://www.drugs.com/levsin.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 7.6 | 17 | https://www.drugs.com/mtm/ketamine.html | https://www.drugs.com/condition/depression.html |
Nardil | Depression | hives ; difficulty breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Nardil may cause serious side effects. Call your doctor at once if you have: sudden and severe headache, neck pain or stiffness; pounding heartbeats or fluttering in your chest; fast or slow heartbeats; chest pain; a light-headed feeling, like you might pass out; sweating (sometimes with fever and sometimes with cold, clammy skin); nausea, vomiting; or dilated pupils (your eyes may be more sensitive to light). Common side effects of Nardil may include: dizziness , feeling light-headed; drowsiness, sleep problems; headache; feeling weak or tired; tremors, muscle twitching ; dry mouth, stomach discomfort, constipation ; swelling, weight gain; or sexual problems. | phenelzine | Monoamine oxidase inhibitors | 2% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 8.4 | 103 | https://www.drugs.com/mtm/nardil.html | https://www.drugs.com/condition/depression.html | ||
Norpramin | Depression | Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: Incidence not known Abdominal or stomach pain anxiety black, tarry stools blurred or double vision burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings chest pain or discomfort confusion about identity, place, and time convulsions cough or hoarseness dark urine dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position dry mouth fainting fast, irregular, pounding, or racing heartbeat or pulse inability to move the arms, legs, or facial muscles inability to speak irritability light-colored stools lightheadedness loss of appetite loss of bladder control muscle spasms or jerking of all extremities nausea nightmares pain or discomfort in the arms, jaw, back, or neck painful or difficult urination pinpoint red or purple spots on the skin pounding in the ears rash restlessness seeing, hearing, or feeling things that are not there shakiness and unsteady walk slow speech sore throat and fever sores, ulcers, or white spots on the lips or in the mouth stiffness of the limbs sudden loss of consciousness sweating swelling swollen glands talking, feeling, and acting with excitement trouble sleeping twisting body movements unsteadiness, trembling, or problems with muscle control or coordination unusual bleeding or bruising unusual tiredness or weakness vomiting yellow eyes and skin Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Incidence not known Abdominal or stomach cramps bigger, dilated, or enlarged pupils (black part of the eye) bloating constipation decrease in the frequency of urination decrease in urine volume decreased interest in sexual intercourse diarrhea difficulty in passing urine (dribbling) hair loss or thinning of the hair inability to have or keep an erection increased in sexual ability, desire, drive, or performance increased interest in sexual intercourse increased sensitivity of the eyes to light loss in sexual ability, desire, drive, or performance painful urination swelling of the breasts or breast soreness in both females and males swelling or inflammation of the mouth unexpected or excess milk flow from breasts in females Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Norpramin side effects | desipramine (oral route) | Tricyclic antidepressants | 2% | Rx | N | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 9.8 | 5 | https://www.drugs.com/cons/norpramin.html | https://www.drugs.com/condition/depression.html | |
Pamelor | Depression | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Pamelor may cause serious side effects. Call your doctor at once if you have: blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; restless muscle movements in your eyes, tongue, jaw, or neck; a light-headed feeling, like you might pass out; seizure (convulsions); new or worsening chest pain, pounding heartbeats or fluttering in your chest; sudden numbness or weakness, problems with vision, speech, or balance; fever, sore throat , easy bruising, unusual bleeding; painful or difficult urination; or jaundice (yellowing of the skin or eyes). Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate , muscle stiffness, twitching, loss of coordination, nausea , vomiting, or diarrhea . Common side effects of Pamelor may include: increased blood pressure; numbness or tingling in your hands or feet; dry mouth, nausea, vomiting, loss of appetite; blurred vision; rash, itching; or breast swelling (in men or women). | nortriptyline | Tricyclic antidepressants | 2% | Rx | N | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | amitriptyline: https://www.drugs.com/amitriptyline.html | citalopram: https://www.drugs.com/citalopram.html | venlafaxine: https://www.drugs.com/venlafaxine.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | nortriptyline: https://www.drugs.com/nortriptyline.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 4.4 | 11 | https://www.drugs.com/mtm/pamelor.html | https://www.drugs.com/condition/depression.html | |
phenelzine | Depression | hives ; difficulty breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Phenelzine may cause serious side effects. Call your doctor at once if you have: sudden and severe headache, neck pain or stiffness; pounding heartbeats or fluttering in your chest; fast or slow heartbeats; chest pain; a light-headed feeling, like you might pass out; sweating (sometimes with fever and sometimes with cold, clammy skin); nausea, vomiting; or dilated pupils (your eyes may be more sensitive to light). Common side effects of phenelzine may include: dizziness , feeling light-headed; drowsiness, sleep problems; headache; feeling weak or tired; tremors, muscle twitching ; dry mouth, stomach discomfort, constipation ; swelling, weight gain; or sexual problems. | phenelzine | Monoamine oxidase inhibitors | Nardil | 2% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 8.6 | 130 | https://www.drugs.com/mtm/phenelzine.html | https://www.drugs.com/condition/depression.html | |
tranylcypromine | Depression | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Tranylcypromine may cause serious side effects. Call your doctor at once if you have: dilated pupils, vision problems, sensitivity to light; sudden and severe headache, neck pain or stiffness; numbness or weakness, problems with vision or speech; fast or pounding heartbeats; fever, cold sweat, nausea, vomiting; a light-headed feeling, like you might pass out; a seizure; manic episodes--racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative; high levels of serotonin in the body--agitation, hallucinations, sweating, shivering, muscle stiffness, twitching, loss of coordination, vomiting, diarrhea ; or liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes). Serious side effects may be more likely in older adults. Common side effects of tranylcypromine may include: dizziness , drowsiness; constipation ; dry mouth, blurred vision; trouble sleeping; headache; or feeling shaky or excited. | tranylcypromine | Monoamine oxidase inhibitors | Parnate | 2% | Rx | N | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 8.3 | 108 | https://www.drugs.com/mtm/tranylcypromine.html | https://www.drugs.com/condition/depression.html |
isocarboxazid | Depression | hives ; difficulty breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Stop taking isocarboxazid and call your doctor at once if you have: sudden and severe headache , rapid heartbeat, stiffness in your neck, nausea , vomiting , cold sweat, vision problems, sensitivity to light; chest pain, fast or slow heart rate ; swelling, rapid weight gain; jaundice (yellowing of the skin or eyes); or a light-headed feeling, like you might pass out. Common side effects of isocarboxazid may include: headache, dizziness , drowsiness; tremors; sleep problems ( insomnia ); constipation , nausea; or dry mouth. | isocarboxazid | Monoamine oxidase inhibitors | Marplan | 1% | Rx | C | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 9 | 6 | https://www.drugs.com/mtm/isocarboxazid.html | https://www.drugs.com/condition/depression.html |
levomilnacipran | Depression | skin rash or hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself. Levomilnacipran may cause serious side effects. Call your doctor at once if you have: blurred vision, tunnel vision, eye pain or swelling, eye redness ; painful or difficult urination; easy bruising, unusual bleeding, purple or red spots under your skin; pounding heartbeats or fluttering in your chest; seizure (convulsions); manic episodes--racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative; or low sodium level-- headache , confusion, slurred speech, severe weakness, vomiting , loss of coordination, feeling unsteady. Serious side effects may be more likely in older adults. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate , muscle stiffness, twitching, loss of coordination, nausea , vomiting, or diarrhea . Common side effects of levomilnacipran may include: nausea, vomiting, constipation ; irregular heartbeats; sweating; or decreased sex drive, impotence , or difficulty having an orgasm. | levomilnacipran | Serotonin-norepinephrine reuptake inhibitors | Fetzima | 1% | Rx | C | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Prozac: https://www.drugs.com/prozac.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 4.9 | 102 | https://www.drugs.com/mtm/levomilnacipran.html | https://www.drugs.com/condition/depression.html |
Marplan | Depression | hives ; difficulty breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Stop taking Marplan and call your doctor at once if you have: sudden and severe headache , rapid heartbeat, stiffness in your neck, nausea , vomiting , cold sweat, vision problems, sensitivity to light; chest pain, fast or slow heart rate ; swelling, rapid weight gain; jaundice (yellowing of the skin or eyes); or a light-headed feeling, like you might pass out. Common side effects of Marplan may include: headache, dizziness , drowsiness; tremors; sleep problems ( insomnia ); constipation , nausea; or dry mouth. | isocarboxazid | Monoamine oxidase inhibitors | 1% | Rx | C | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 9 | 6 | https://www.drugs.com/mtm/marplan.html | https://www.drugs.com/condition/depression.html | ||
Tofranil | Depression | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Tofranil may cause serious side effects. Call your doctor at once if you have: easy bruising, unusual bleeding, purple or red spots under your skin; tunnel vision, eye pain or swelling, or seeing halos around lights; a light-headed feeling, like you might pass out; new or worsening chest pain, pounding heartbeats or fluttering in your chest; sudden numbness or weakness, problems with vision, speech, or balance; fever, sore throat ; confusion, hallucinations, unusual thoughts or behavior; painful or difficult urination; seizure (convulsions); or jaundice (yellowing of the skin or eyes). Common side effects of Tofranil may include: increased blood pressure; tingly feeling, weakness, lack of coordination; dry mouth, nausea , vomiting ; or breast swelling (in men or women). | imipramine | Tricyclic antidepressants | 1% | Rx | N | N | X | Trintellix: https://www.drugs.com/trintellix.html | Buprenex: https://www.drugs.com/buprenex.html | aspirin: https://www.drugs.com/aspirin.html | acetaminophen: https://www.drugs.com/acetaminophen.html | sertraline: https://www.drugs.com/sertraline.html | tramadol: https://www.drugs.com/tramadol.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | Tylenol: https://www.drugs.com/tylenol.html | naproxen: https://www.drugs.com/naproxen.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 5.8 | 6 | https://www.drugs.com/mtm/tofranil.html | https://www.drugs.com/condition/depression.html | |
trimipramine | Depression | hives ; difficulty breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Trimipramine may cause serious side effects. Call your doctor at once if you have: tunnel vision, eye pain or swelling, or seeing halos around lights; a light-headed feeling, like you might pass out; new or worsening chest pain, pounding heartbeats or fluttering in your chest; confusion, unusual thoughts or behavior; a seizure (convulsions); painful or difficult urination; easy bruising, unusual bleeding; restless muscle movements in your eyes, tongue, jaw, or neck; or fever, chills, sore throat , mouth sores, feeling light-headed. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate , muscle stiffness, twitching, loss of coordination, nausea , vomiting, or diarrhea . Common side effects of trimipramine may include: increased blood pressure; numbness or tingling in your hands or feet; dry mouth, nausea, vomiting; rash, itching; breast swelling (in men or women); or abnormal liver function tests . | trimipramine | Tricyclic antidepressants | Surmontil | 1% | Rx | C | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 9 | 2 | https://www.drugs.com/mtm/trimipramine.html | https://www.drugs.com/condition/depression.html |
Vivactil | Depression | Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: Incidence not known Abdominal or stomach pain agitation or irritability blurred vision burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings change in urination chest pain or discomfort clay-colored stools cold sweats confusion about identity, place, and time continuing ringing, buzzing, or other unexplained noise in the ears convulsions cool, pale skin difficulty with speaking dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position double vision drooling false beliefs that cannot be changed by facts fast, pounding, or irregular heartbeat or pulse feeling of warmth feeling, seeing, or hearing things that are not there feeling that others are watching you or controlling your behavior feeling that others can hear your thoughts fever with or without chills hearing loss hostility hyperventilation inability to move the arms, legs, or facial muscles lack of coordination lower back or side pain mood or mental changes muscle spasm or jerking of all extremities muscle trembling or twitching nightmares pain or discomfort in the arms, jaw, back, or neck panic pinpoint red or purple spots on the skin pounding in the ears redness of the face, neck, arms, and occasionally, upper chest shakiness and unsteady walk slurred speech sore throat sores, ulcers, or white spots on the lips or in the mouth stiffness of the limbs stupor sweating swelling of face, ankles, or hands swollen glands talking, feeling, and acting with excitement trouble sleeping twisting movements of body uncontrolled movements, especially of the face, neck, and back unusual behavior unusual bleeding or bruising unusual tiredness or weakness weakness in the arms, hands, legs, or feet weight gain or loss yellow eyes or skin Symptoms of overdose Change in consciousness clumsiness disorientation disturbed concentration drowsiness to profound coma enlarged pupils increased or excessive unconscious or jerking movements low body temperature muscle aches or tightness muscle weakness severe sleepiness shivering trouble breathing weak or feeble pulse Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Incidence not known Abdominal or stomach cramps bigger, dilated, or enlarged pupils (black part of the eye) black tongue difficulty having a bowel movement (stool) enlargement or swelling of the breasts hair loss or thinning of the hair heartburn hives or welts increased in sexual ability, desire, drive, or performance increased sensitivity of the eyes to light increased sensitivity of the skin to sunlight pain or discomfort in the chest, upper stomach, or throat peculiar taste severe sunburn small red or purple spots on the skin swelling of the testicles swelling or inflammation of the mouth swollen, painful, or tender lymph glands on side of the face or neck unexpected or excess milk flow from the breasts waking to urinate at night Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Vivactil side effects | protriptyline (oral route) | Tricyclic antidepressants | 1% | Rx | N | N | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 9 | 2 | https://www.drugs.com/cons/vivactil.html | https://www.drugs.com/condition/depression.html | ||
XaQuil XR | Depression | hives ; difficulty breathing; swelling of your face, lips, tongue, or throat. Less serious side effects may occur, and you may have none at all. | l-methylfolate | Vitamins | Deplin, L-Methylfolate Formula | 1% | Rx | N | N | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 9 | 3 | https://www.drugs.com/mtm/xaquil-xr.html | https://www.drugs.com/condition/depression.html | ||
esketamine | Depression | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Your blood pressure will need to be checked before and after you use esketamine. Esketamine can increase your blood pressure for several hours after each dose. Tell your doctor if you have chest pain, trouble breathing, severe headache , blurred vision, pounding in your neck or ears, or a seizure. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Also call your doctor at once if you have: extreme drowsiness or feeling like you might pass out; severe dizziness or feelings of floating; problems with thinking or memory; unusual or unpleasant memories (flashbacks); hallucinations, feeling "spaced out"; or urination problems (painful urination, increased urination, urgent need to urinate). Common side effects of esketamine may include: dissociation, feeling drunk; increased blood pressure; drowsiness, lack of energy; dizziness, spinning sensation; feeling anxious; nausea, vomiting; or decreased sensations (touch or other senses). | esketamine (nasal) | Miscellaneous antidepressants | Spravato | 0% | Rx | 3 | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Prozac: https://www.drugs.com/prozac.html | esketamine: https://www.drugs.com/mtm/esketamine-nasal.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 5.6 | 63 | https://www.drugs.com/mtm/esketamine-nasal.html | https://www.drugs.com/condition/depression.html | |
L-Methylfolate Forte | Depression | WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives ; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. L-Methylfolate Forte side effects | Methylfolate | Vitamins | Denovo, Elfolate | 0% | Rx | N | N | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | null | null | https://www.drugs.com/cdi/l-methylfolate-forte.html | https://www.drugs.com/condition/depression.html | ||
protriptyline | Depression | hives , rash, red or purple spots; fever; difficult breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety , panic attacks , trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Protriptyline may cause serious side effects. Call your doctor at once if you have: fever, chills, sore throat , mouth sores, feeling light-headed; blurred vision, eye pain or redness, seeing halos around lights; restless muscle movements in your eyes, tongue, jaw, or neck; seizure (convulsions); new or worsening chest pain, pounding heartbeats or fluttering in your chest; sudden numbness or weakness, problems with vision, or speech; easy bruising, unusual bleeding; painful or difficult urination; or jaundice (yellowing of the skin or eyes). Common side effects of protriptyline may include: fast heartbeats; problems with balance or muscle movement; constipation ; nausea , vomiting , loss of appetite; breast swelling (in men or women); or decreased sex drive, impotence . | protriptyline | Tricyclic antidepressants | Vivactil | 0% | Rx | N | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 9 | 2 | https://www.drugs.com/mtm/protriptyline.html | https://www.drugs.com/condition/depression.html |
Spravato | Depression | hives ; difficult breathing; swelling of your face, lips, tongue, or throat. Your blood pressure will need to be checked before and after you use Spravato. Esketamine can increase your blood pressure for several hours after each dose. Tell your doctor if you have chest pain, trouble breathing, severe headache , blurred vision, pounding in your neck or ears, or a seizure. Also call your doctor at once if you have: extreme drowsiness or feeling like you might pass out; severe dizziness or feelings of floating; unusual changes in mood or behavior; thoughts of hurting yourself; worsening depression; sleep problems; problems with thinking or memory; unusual or unpleasant memories (flashbacks); hallucinations, feeling "spaced out"; or urination problems (painful urination, increased urination, urgent need to urinate). Common Spravato side effects may include: dissociation, feeling drunk; increased blood pressure; drowsiness; dizziness, spinning sensation; feeling anxious; nausea, vomiting; or decreased sensations (touch or other senses). | esketamine (nasal) | Miscellaneous antidepressants | 0% | Rx | 3 | X | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 5.6 | 57 | https://www.drugs.com/spravato.html | https://www.drugs.com/condition/depression.html | |||
Surmontil | Depression | Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: Incidence not known Abdominal or stomach pain agitation black, tarry stools bleeding or bruising blood in the urine or stools blurred vision burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings chest pain or discomfort clay-colored stools cold sweats confusion about identity, place, and time continuing ringing, buzzing, or other unexplained noise in the ears convulsions cool, pale skin cough or hoarseness dark urine decrease in the frequency of urination decreased urine output or volume depression difficulty in passing urine (dribbling) difficulty with speaking dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position double vision drooling dry mouth false beliefs that cannot be changed by facts fast, pounding, or irregular heartbeat or pulse feeling of warmth feeling that others are watching you or controlling your behavior feeling that others can hear your thoughts feeling, seeing, or hearing things that are not there fever with or without chills flushed, dry skin fruit-like breath odor general feeling of tiredness or weakness headache hearing loss hostility hyperventilation inability to move the arms, legs, or facial muscles inability to speak increased hunger increased need to urinate increased thirst increased urination irritability itching or rash lack of coordination lethargy loss of appetite loss of balance control lower back or side pain mood or mental changes muscle spasm or jerking of all extremities muscle trembling or stiffness muscle twitching nausea nightmares pain or discomfort in the arms, jaw, back, or neck painful or difficult urination passing urine more often pinpoint red or purple spots on the skin pounding in the ears rapid weight gain redness of the face, neck, arms, and occasionally, upper chest restlessness shakiness and unsteady walk shuffling walk slow speech slurred speech sore throat sores, ulcers, or white spots on the lips or in the mouth stiffness of the limbs sudden loss of consciousness sweating swelling of the face, ankles, legs, or hands swollen glands talking, feeling, and acting with excitement trouble in holding or releasing urine trouble sleeping twisting movements of the body uncontrolled movements, especially of the face, neck, and back unpleasant breath odor unsteadiness, awkwardness, trembling, or other problems with muscle control or coordination unusual behavior unusual tiredness or weakness vomiting of blood weakness in the arms, hands, legs, or feet weight gain or loss yellow eyes or skin Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Incidence not known Abdominal or stomach cramps bigger, dilated, or enlarged pupils (black part of the eye) black tongue bloating decreased interest in sexual intercourse diarrhea difficulty having a bowel movement (stool) disturbance of accommodation enlargement of the breast hair loss or thinning of the hair heartburn hives or welts inability to have or keep an erection increase in sexual ability, desire, drive, or performance increased sensitivity of the eyes to light increased sensitivity of the skin to sunlight loss in sexual ability, desire, drive, or performance pain or discomfort in the chest, upper stomach, or throat peculiar taste redness or other discoloration of the skin severe sunburn small red or purple spots on the skin swelling of the breasts or breast soreness in both women and men swelling of the testicles swelling or inflammation of the mouth swollen, painful, or tender lymph glands in the neck unexpected milk flow from the breasts Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Surmontil side effects | trimipramine (oral route) | Tricyclic antidepressants | 0% | Rx | C | N | X | Trintellix: https://www.drugs.com/trintellix.html | sertraline: https://www.drugs.com/sertraline.html | trazodone: https://www.drugs.com/trazodone.html | Lexapro: https://www.drugs.com/lexapro.html | citalopram: https://www.drugs.com/citalopram.html | Zoloft: https://www.drugs.com/zoloft.html | Cymbalta: https://www.drugs.com/cymbalta.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | 0 | 1 | https://www.drugs.com/cons/surmontil.html | https://www.drugs.com/condition/depression.html | |
thyroid desiccated | Depression | hives; difficult breathing; swelling of your face, lips, tongue, or throat. Less serious side effects may include temporary hair loss (especially in children). | thyroid (desiccated) | Thyroid drugs | Armour Thyroid, Nature-Throid, Westhroid | 0% | Rx | A | N | levothyroxine: https://www.drugs.com/levothyroxine.html | Synthroid: https://www.drugs.com/synthroid.html | Euthyrox: https://www.drugs.com/euthyrox.html | Armour Thyroid: https://www.drugs.com/mtm/armour-thyroid.html | liothyronine: https://www.drugs.com/mtm/liothyronine.html | doxorubicin: https://www.drugs.com/mtm/doxorubicin.html | Levoxyl: https://www.drugs.com/levoxyl.html | Tirosint: https://www.drugs.com/cons/tirosint.html | NP Thyroid: https://www.drugs.com/mtm/np-thyroid.html | sorafenib: https://www.drugs.com/mtm/sorafenib.html | Depression Depression is a mood condition characterized by persistent and overwhelming feelings of sadness that can affect your day-to-day activities and how you think, feel, and behave. Sometimes it can affect your outlook on life and make you feel that life isn’t worth living. Depression may also be called major depressive disorder or clinical depression. What Causes Depression? Experts aren’t exactly sure what causes depression but believe it is due to a combination of different factors, such as genetic vulnerability, faulty mood regulation by the brain, stress, chemicals in the brain, medications, or medical problems, that all interact together to bring on depression. The risk of developing depression is higher in women and people: Aged 45 to 64 years of age or the elderly With chronic or acute health conditions Who are undergoing a major life event, such as a job loss, divorce, workplace stress, or physical or mental abuse With severe grief due to the death of a loved one Taking prescription drugs that may cause a low mood Abusing alcohol or drugs. What are the Symptoms of Depression? Depression is not just feeling blue occasionally. It affects daily feelings, thoughts, and actions over a longer period. (MDD), can result in difficulties with family life, work, and social activities. Symptoms may vary depending on how severe a person’s depression is but may include: A prolonged and persistent low mood, tearfulness, or a sense of hopelessness that has lasted for at least 2 weeks Irritability Anxiety Agitation or restlessness Avoidance or refusal to participate in activities that were previously enjoyed Withdrawal socially, from family, friends, and relationships Changes in sleeping or eating habits Unexplained physical problems, such as back pain or headaches Alcohol, drug, or substance abuse Engaging in risky or destructive behaviors Self-harm or attempts at suicide. In children and teens, symptoms may include clinginess, worry, aches and pain, and refusal to go to school. In older adults, symptoms may be less obvious and include memory difficulties or personality changes, physical aches and pains, and fatigue. How is Depression Diagnosed? If your mood has been low for a while and you are having difficulty coping with day to day activities, talk to your doctor or a trusted professional. Your doctor will ask you questions about your symptoms and your medical history and may ask you to complete a questionnaire that may help to diagnose depression or refer you to a psychiatrist. You can also call the National Suicide Prevention Hotline at 1-800-273-8255, 24 hours a day, 7 days a week, or have an online chat (http://suicidepreventionlifeline.org/). All information is confidential and free. How is Depression Treated? Depression is treatable with high rates of success. Treatments may include: Psychotherapy Antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs). Responses to antidepressants vary, and most antidepressants take 4 to 6 weeks for full effect. About 50% of patients respond to the first treatment, whereas others may have to try a few different types of antidepressants before they find the best one for them. There are several things you can do to help with your symptoms as well, such as: Setting realistic and daily goals Developing strategies to work through crises situations Developing coping and problem-solving skills Learning how to develop positive relationships Replacing negative thoughts with positive ones. | null | null | https://www.drugs.com/thyroid.html | https://www.drugs.com/condition/depression.html |
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