Seq Labeling Tasks
Collection
PICO stands for the framework is used in evidence-based medicine to frame and answer a clinical question.
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Title : Oseltamivir for coronavirus illness : post - hoc exploratory analysis of an open - label , pragmatic , randomised controlled trial in European primary care from 2016 to 2018 . METHODS : Exploratory analysis of data from an open - label , pragmatic , randomised controlled trial during three influenza seasons , from 2016 to 2018 , in primary care research networks , in 15 European countries . Patients aged ?1 year presenting to primary care with influenza - like illness ( ILI ) , and who tested positive for coronavirus ( not including SARS - CoV - 2 ) , were randomised to usual care or usual care plus oseltamivir . The primary outcome was time to recovery defined as a return to usual activities , with minor or absent fever , headache , and muscle ache .
|
{
"P": [
"Patients aged ?1 year presenting to primary care with influenza - like illness ( ILI ) , and who tested positive for coronavirus ( not including SARS - CoV - 2 )"
],
"I": [
"Oseltamivir",
"usual care",
"oseltamivir"
],
"C": [
"usual care"
],
"O": [
"time to recovery",
"a return to usual activities",
"minor",
"absent fever",
"headache",
"muscle ache"
]
}
|
Title : The effect of propolis supplementation on clinical symptoms in patients with coronavirus ( COVID - 19 ) : A structured summary of a study protocol for a randomised controlled trial . METHODS : This is a Double - Blind , Placebo - Controlled , Parallel Arm , Randomized Phase ?? Clinical Trial . Patients with the confirmed COVID - 19 based on the PCR test are eligible to participate in the trial if they are 18 to 75 years of age and have no history of the current use of warfarin or propolis supplement and presence of sensitivity to bee products . Patients will be recruited from the Al - Zahra hospital in Isfahan city , Isfahan , Iran . METHODS : Eligible patients will be randomly allocated in a 1 : 1 ratio to the intervention or control group . Randomization will be performed on the basis of permuted block sizes of 4 and will be stratified according to sex categories . Randomization sequences will be prepared by the trial ' s pharmacist with the use of random - number tables . The trial - group assignment will be concealed from all participants , clinicians , and investigators throughout the trial . To ensure blinding , randomization sequences will be kept in identical , opaque , sealed , sequentially numbered envelopes . Only the trial ' s pharmacist has access to the randomization list . Also , the placebo tablet will be similar to the propolis tablet in terms of texture , taste , color , odor , and weight . Both tablets will be provided in containers that are completely identical in weight , shape , labelling , and packaging . The calculated total sample size is 80 patients , with 40 patients in each group . The protocol is Version 1 . 0 , October 10 , 2020 . Recruitment began August 22 , 2020 , and is anticipated to be completed by March 21 , 2021 . METHODS : The full protocol is attached as an additional file , accessible from the Trials website ( Additional file 1 ) . In the interest of expediting the dissemination of this material , the familiar formatting has been eliminated ; this Letter serves as a summary of the key elements of the full protocol .
|
{
"P": [
"patients with coronavirus",
"Patients with the confirmed COVID - 19 based on the PCR test are eligible to participate in the trial if they are 18 to 75 years of age and have no history of the current use of warfarin or propolis supplement and presence of sensitivity to bee products"
],
"I": [
"propolis supplementation"
],
"C": [],
"O": []
}
|
Title : COvid - 19 and high - dose VITamin D supplementation TRIAL in high - risk older patients ( COVIT - TRIAL ) : study protocol for a randomized controlled trial . METHODS : The COVIT - TRIAL study is an open - label , multicenter , randomized controlled superiority trial . Patients aged ? 65 years with COVID - 19 ( diagnosed within the preceding 3 days with RT - PCR and / or chest CT scan ) and at least one worsening risk factor at the time of inclusion ( i . e . , age ? 75 years , or SpO2 ? 94 % in room air , or PaO2 / FiO2 ? 300 mmHg ) , having no contraindications to vitamin D supplementation , and having received no vitamin D supplementation > 800 IU / day during the preceding month are recruited . Participants are randomized either to high - dose cholecalciferol ( two 200 , 000 IU drinking vials at once on the day of inclusion ) or to standard - dose cholecalciferol ( one 50 , 000 IU drinking vial on the day of inclusion ) . Two hundred sixty participants are recruited and followed up for 28 days . The primary outcome measure is all - cause mortality within 14 days of inclusion . Secondary outcomes are the score changes on the World Health Organization Ordinal Scale for Clinical Improvement ( OSCI ) scale for COVID - 19 , and the between - group comparison of safety . These outcomes are assessed at baseline , day 14 , and day 28 , together with the serum concentrations of 25 ( OH ) D , creatinine , calcium , and albumin at baseline and day 7 .
|
{
"P": [
"high - risk older patients",
"Patients aged ? 65 years with COVID - 19 ( diagnosed within the preceding 3 days with RT - PCR and / or chest CT scan ) and at least one worsening risk factor at the time of inclusion ( i . e . , age ? 75 years , or SpO2 ? 94 % in room air , or PaO2 / FiO2 ? 300 mmHg ) , having no contraindications to vitamin D supplementation , and having received no vitamin D supplementation > 800 IU / day during the preceding month",
"Two hundred sixty participants"
],
"I": [
"high - dose VITamin D supplementation",
"high - dose cholecalciferol"
],
"C": [
"standard - dose cholecalciferol"
],
"O": [
"all - cause mortality",
"the World Health Organization Ordinal Scale for Clinical Improvement ( OSCI ) scale for COVID - 19",
"safety",
"the serum concentrations of 25 ( OH ) D",
"creatinine",
"calcium",
"albumin"
]
}
|
Title : Metoprolol in Critically Ill Patients With COVID - 19 . METHODS : A total of 20 COVID - 19 patients with ARDS on invasive mechanical ventilation were randomized to metoprolol ( 15 mg daily for 3 days ) or control ( no treatment ) . All patients underwent bronchoalveolar lavage ( BAL ) before and after metoprolol / control . The safety of metoprolol administration was evaluated by invasive hemodynamic and electrocardiogram monitoring and echocardiography .
|
{
"P": [
"Critically Ill Patients With COVID - 19",
"A total of 20 COVID - 19 patients with ARDS on invasive mechanical ventilation"
],
"I": [
"Metoprolol",
"metoprolol"
],
"C": [
"no treatment"
],
"O": [
"invasive hemodynamic",
"electrocardiogram monitoring",
"echocardiography"
]
}
|
Title : Efficacy and safety of pegylated interferon alfa - 2 b in moderate COVID - 19 : A phase II , randomized , controlled , open - label study . METHODS : In this phase 2 , randomized , open - label study , adult subjects aged ?18 years with RT - PCR confirmed COVID - 19 with moderate symptoms were randomized in a 1 : 1 to receive PEG IFN - ?2b plus SOC , or SOC alone . The primary endpoint was improvement in clinical status on day 15 , measured by the WHO 7 - point ordinal scale .
|
{
"P": [
"adult subjects aged ?18 years with RT - PCR confirmed COVID - 19 with moderate symptoms"
],
"I": [
"pegylated interferon alfa - 2 b",
"PEG IFN - ?2b",
"SOC"
],
"C": [
"SOC alone"
],
"O": [
"clinical status",
"the WHO 7 - point ordinal scale"
]
}
|
Title : Homemade valved holding chambers for children with airway hyperresponsiveness : A randomized crossover trial . METHODS : In a randomized , two - period , two - sequence crossover trial , we recruited 20 children , aged 6 - 15 years , who had a greater than 12 % increase in FEV1 after inhaled salbutamol . They were randomized into Group A and B . Group A used our VHC on the first day and Aerochamber on the second day . Group B used the same VHCs but in alternate sequence . Spirometries were performed before and after 400 g of salbutamol , MDI was administered via those VHCs .
|
{
"P": [
"children with airway hyperresponsiveness",
"20 children , aged 6 - 15 years , who had a greater than 12 % increase in FEV1 after inhaled salbutamol"
],
"I": [
"Homemade valved holding chambers",
"our VHC",
"Aerochamber",
"the same VHCs",
"those VHCs"
],
"C": [],
"O": [
"Spirometries"
]
}
|
Title : Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid - 19 . METHODS : In this open - label , adaptive , multiplatform , controlled trial , we randomly assigned patients who were hospitalized with Covid - 19 and who were not critically ill ( which was defined as an absence of critical care - level organ support at enrollment ) to receive pragmatically defined regimens of either therapeutic - dose anticoagulation with heparin or usual - care pharmacologic thromboprophylaxis . The primary outcome was organ support - free days , evaluated on an ordinal scale that combined in - hospital death ( assigned a value of - 1 ) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge . This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d - dimer level .
|
{
"P": [
"Noncritically Ill Patients with Covid - 19",
"patients who were hospitalized with Covid - 19 and who were not critically ill ( which was defined as an absence of critical care - level organ support at enrollment )"
],
"I": [
"Heparin",
"therapeutic - dose anticoagulation with heparin"
],
"C": [
"usual - care pharmacologic thromboprophylaxis"
],
"O": [
"organ support - free days",
"an ordinal scale",
"in - hospital death",
"the number of days free of cardiovascular",
"respiratory organ support"
]
}
|
Title : Combined use of a broad - panel respiratory multiplex PCR and procalcitonin to reduce duration of antibiotics exposure in patients with severe community - acquired pneumonia ( MULTI - CAP ) : a multicentre , parallel - group , open - label , individual randomised trial conducted in French intensive care units . METHODS : The multiplex PCR and procalcitonin to reduce duration of antibiotics exposure in patients with severe - CAP ( MULTI - CAP ) trial is a multicentre ( n=20 ) , parallel - group , superiority , open - label , randomised trial . Patients are included if adult admitted to intensive care unit for a CAP . Diagnosis of pneumonia is based on clinical criteria and a newly appeared parenchymal infiltrate . Immunocompromised patients are excluded . Subjects are randomised ( 1 : 1 ratio ) to either the intervention arm ( experimental strategy ) or the control arm ( usual strategy ) . In the intervention arm , the microbiological diagnosis combines a respiratory multiplex PCR ( mPCR ) and conventional microbiological investigations . An algorithm of early antibiotic de - escalation or discontinuation is recommended , based on mPCR results and the procalcitonin value . In the control arm , only conventional microbiological investigations are performed and antibiotics de - escalation remains at the clinician ' s discretion . The primary endpoint is the number of days alive without any antibiotic from the randomisation to day 28 . Based on our hypothesis of 2 days gain in the intervention arm , we aim to enrol a total of 450 patients over a 30 - month period .
|
{
"P": [
"patients with severe community - acquired pneumonia",
"patients with severe - CAP ( MULTI - CAP ) trial",
"adult admitted to intensive care unit for a CAP"
],
"I": [
"a broad - panel respiratory multiplex PCR",
"procalcitonin",
"The multiplex PCR",
"experimental strategy",
"the microbiological diagnosis",
"a respiratory multiplex PCR ( mPCR )",
"conventional microbiological investigations"
],
"C": [
"usual strategy",
"conventional microbiological investigations"
],
"O": [
"the number of days alive without any antibiotic"
]
}
|
Title : Ivermectin to prevent hospitalizations in patients with COVID - 19 ( IVERCOR - COVID19 ) a randomized , double - blind , placebo - controlled trial . METHODS : A randomized , double - blind , placebo - controlled study was conducted in non - hospitalized individuals with COVID - 19 in Corrientes , Argentina . Patients with SARS - CoV - 2 positive nasal swabs were contacted within 48 h by telephone to invite them to participate . The trial randomized 501 patients between August 19 th 2020 and February 22 nd 2021 . Patients were randomized to ivermectin ( N = 250 ) or placebo ( N = 251 ) arms in a staggered dose , according to the patient ' s weight , for 2 days . The efficacy of ivermectin to prevent hospitalizations was evaluated as primary outcome . We evaluated secondary outcomes in relationship to safety and other efficacy end points .
|
{
"P": [
"patients with COVID - 19",
"non - hospitalized individuals with COVID - 19 in Corrientes , Argentina",
"Patients with SARS - CoV - 2 positive nasal swabs",
"501 patients between August 19 th 2020 and February 22 nd 2021"
],
"I": [
"Ivermectin",
"ivermectin"
],
"C": [
"placebo"
],
"O": [
"hospitalizations",
"safety"
]
}
|
Title : Effect of Recombinant Human Granulocyte Colony - Stimulating Factor for Patients With Coronavirus Disease 2019 ( COVID - 19 ) and Lymphopenia : A Randomized Clinical Trial . METHODS : Between February 18 and April 10 , 2020 , we conducted an open - label , multicenter , randomized clinical trial at 3 participating centers in China . The main eligibility criteria were pneumonia , a blood lymphocyte cell count of 800 per ?L ( to convert to 109 / L , multiply by 0 . 001 ) or lower , and no comorbidities . Severe acute respiratory syndrome coronavirus 2 infection was confirmed with reverse - transcription polymerase chain reaction testing . Usual care alone , or usual care plus 3 doses of recombinant human granulocyte colony - stimulating factor ( rhG - CSF , 5 ?g / kg , subcutaneously at days 0 - 2 ) . The primary end point was the time from randomization to improvement of at least 1 point on a 7 - category disease severity score .
|
{
"P": [
"Patients With Coronavirus Disease 2019 ( COVID - 19 ) and Lymphopenia"
],
"I": [
"Recombinant Human Granulocyte Colony",
"usual care",
"3 doses of recombinant human granulocyte colony - stimulating factor ( rhG - CSF"
],
"C": [
"Usual care alone"
],
"O": [
"the time from randomization to improvement",
"a 7 - category disease severity score"
]
}
|
Title : Hydroxychloroquine in mild - to - moderate coronavirus disease 2019 : a placebo - controlled double blind trial . METHODS : We conducted a multicentre randomized double - blind placebo - controlled trial evaluating hydroxychloroquine in COVID - 19 patients with at least one of the following risk factors for worsening : need for supplemental oxygen , age ?75 years , age between 60 and 74 years and presence of at least one co - morbidity . Severely ill patients requiring oxygen therapy > 3 L / min or intensive care were excluded . Eligible patients were randomized in a 1 : 1 ratio to receive either 800 mg hydroxychloroquine on day 0 followed by 400 mg per day for 8 days or a placebo . The primary end point was a composite of death or start of invasive mechanical ventilation within 14 days following randomization . Secondary end points included mortality and clinical evolution at days 14 and 28 , and viral shedding at days 5 and 10 .
|
{
"P": [
"COVID - 19 patients with at least one of the following risk factors for worsening : need for supplemental oxygen , age ?75 years , age between 60 and 74 years and presence of at least one co - morbidity"
],
"I": [
"Hydroxychloroquine",
"hydroxychloroquine",
"800 mg hydroxychloroquine"
],
"C": [
"a placebo"
],
"O": [
"a composite of death",
"start of invasive mechanical ventilation",
"mortality",
"clinical evolution",
"viral shedding"
]
}
|
Title : Comparison of losartan and amlodipine effects on the outcomes of patient with COVID - 19 and primary hypertension : A randomised clinical trial . METHODS : In this randomised clinical trial , hospitalised patients with COVID - 19 and primary HTN were enrolled in the study . One arm received losartan , 25 mg , twice a day and the other arm received amlodipine , 5 mg per day for 2 weeks . The main outcomes were compare 30 - day mortality rate and length of hospital stay .
|
{
"P": [
"patient with COVID - 19 and primary hypertension",
"hospitalised patients with COVID - 19 and primary HTN"
],
"I": [
"losartan",
"amlodipine"
],
"C": [],
"O": [
"compare 30 - day mortality rate",
"length of hospital stay"
]
}
|
Title : Cytokine adsorption in patients with severe COVID - 19 pneumonia requiring extracorporeal membrane oxygenation ( CYCOV ) : a single centre , open - label , randomised , controlled trial . METHODS : We did a single - centre , open - label , randomised , controlled trial to investigate cytokine adsorption in adult patients with severe COVID - 19 pneumonia requiring ECMO . Patients with COVID - 19 selected for ECMO at the Freiburg University Medical Center ( Freiburg , Germany ) were randomly assigned ( 1 : 1 ) to receive cytokine adsorption using the CytoSorb device or not . Randomisation was computer - generated , allocation was concealed by opaque , sequentially numbered sealed envelopes . The CytoSorb device was incorporated into the ECMO circuit before connection to the patient circuit , replaced every 24 h , and removed after 72 h . The primary endpoint was serum interleukin - 6 ( IL - 6 ) concentration 72 h after initiation of ECMO analysed by intention to treat . Secondary endpoints included 30 - day survival . The trial is registered with ClinicalTrials . gov ( NCT04324528 ) and the German Clinical Trials Register ( DRKS00021300 ) and is closed .
|
{
"P": [
"patients with severe COVID - 19 pneumonia requiring extracorporeal membrane oxygenation",
"adult patients with severe COVID - 19 pneumonia requiring ECMO",
"Patients with COVID - 19 selected for ECMO at the Freiburg University Medical Center ( Freiburg , Germany )"
],
"I": [
"Cytokine adsorption",
"cytokine adsorption",
"the CytoSorb device"
],
"C": [
"not"
],
"O": [
"serum interleukin - 6 ( IL - 6 ) concentration",
"30 - day survival"
]
}
|
Title : Magnesium treatment on methylation changes of transmembrane serine protease 2 ( TMPRSS2 ) . METHODS : This study is nested within the Personalized Prevention of Colorectal Cancer Trial , a double - blind 2 O 2 factorial randomized controlled trial , which enrolled 250 participants from Vanderbilt University Medical Center .
|
{
"P": [
"250 participants from Vanderbilt University Medical Center"
],
"I": [
"Magnesium treatment"
],
"C": [],
"O": []
}
|
Title : Hydroxychloroquine with or without Azithromycin in Mild - to - Moderate Covid - 19 . METHODS : We conducted a multicenter , randomized , open - label , three - group , controlled trial involving hospitalized patients with suspected or confirmed Covid - 19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen . Patients were randomly assigned in a 1:1:1 ratio to receive standard care , standard care plus hydroxychloroquine at a dose of 400 mg twice daily , or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days . The primary outcome was clinical status at 15 days as assessed with the use of a seven - level ordinal scale ( with levels ranging from one to seven and higher scores indicating a worse condition ) in the modified intention - to - treat population ( patients with a confirmed diagnosis of Covid - 19 ) . Safety was also assessed .
|
{
"P": [
"hospitalized patients with suspected or confirmed Covid - 19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen"
],
"I": [
"Hydroxychloroquine",
"Azithromycin",
"standard care",
"hydroxychloroquine",
"azithromycin"
],
"C": [
"standard care"
],
"O": [
"clinical status",
"a seven - level ordinal scale",
"Safety"
]
}
|
Title : Safety and efficacy of Favipiravir in moderate to severe SARS - CoV - 2 pneumonia . METHODS : We did a multicenter randomized open - labeled clinical trial on moderate to severe cases infections of SARS - CoV - 2 . Patients with typical ground glass appearance on chest computerized tomography scan ( CT scan ) and oxygen saturation ( SpO2 ) of less than 93 % were enrolled . They were randomly allocated into Favipiravir ( 1 . 6 gr loading , 1 . 8 gr daily ) and Lopinavir / Ritonavir ( 800 / 200 mg daily ) treatment regimens in addition to standard care . In - hospital mortality , ICU admission , intubation , time to clinical recovery , changes in daily SpO2 after 5 min discontinuation of supplemental oxygen , and length of hospital stay were quantified and compared in the two groups .
|
{
"P": [
"Patients with typical ground glass appearance on chest computerized tomography scan ( CT scan ) and oxygen saturation ( SpO2 ) of less than 93 %"
],
"I": [
"Favipiravir",
"Lopinavir",
"Ritonavir",
"standard care"
],
"C": [],
"O": [
"In - hospital mortality",
"ICU admission",
"intubation",
"time to clinical recovery",
"daily SpO2",
"length of hospital stay"
]
}
|
Title : Effect of Canakinumab vs Placebo on Survival Without Invasive Mechanical Ventilation in Patients Hospitalized With Severe COVID - 19 : A Randomized Clinical Trial . METHODS : This randomized , double - blind , placebo - controlled phase 3 trial was conducted at 39 hospitals in Europe and the United States . A total of 454 hospitalized patients with COVID - 19 pneumonia , hypoxia ( not requiring invasive mechanical ventilation [ IMV ] ) , and systemic hyperinflammation defined by increased blood concentrations of C - reactive protein or ferritin were enrolled between April 30 and August 17 , 2020 , with the last assessment of the primary end point on September 22 , 2020 . Patients were randomly assigned 1 : 1 to receive a single intravenous infusion of canakinumab ( 450 mg for body weight of 40 - < 60 kg , 600 mg for 60 - 80 kg , and 750 mg for > 80 kg ; n = 227 ) or placebo ( n = 227 ) . The primary outcome was survival without IMV from day 3 to day 29 . Secondary outcomes were COVID - 19 - related mortality , measurements of biomarkers of systemic hyperinflammation , and safety evaluations .
|
{
"P": [
"Patients Hospitalized With Severe COVID - 19",
"A total of 454 hospitalized patients with COVID - 19 pneumonia , hypoxia ( not requiring invasive mechanical ventilation [ IMV ] ) , and systemic hyperinflammation defined by increased blood concentrations of C - reactive protein or ferritin"
],
"I": [
"Canakinumab",
"a single intravenous infusion of canakinumab"
],
"C": [
"Placebo",
"placebo"
],
"O": [
"survival without IMV",
"COVID - 19 - related mortality",
"measurements of biomarkers of systemic hyperinflammation",
"safety evaluations"
]
}
|
Title : A randomized trial in the investigation of anxiety and depression in patients with coronavirus disease 2019 ( COVID - 19 ) . METHODS : Sixty - five COVID - 19 patients were randomly enrolled into this study . Anxiety and depression among participants were measured through the completion of anonymous Chinese - language Zung self - rating anxiety scale and self - rating depression scale questionnaires . Data were analyzed using independent samples t - tests , Mann - Whitney U - tests , and ?2 tests .
|
{
"P": [
"patients with coronavirus disease 2019 ( COVID - 19 )",
"Sixty - five COVID - 19 patients"
],
"I": [],
"C": [],
"O": [
"Anxiety",
"depression",
"anonymous Chinese - language Zung self - rating anxiety scale",
"self - rating depression scale questionnaires"
]
}
|
Title : A Phase II Safety and Efficacy Study on Prognosis of Moderate Pneumonia in Coronavirus Disease 2019 Patients With Regular Intravenous Immunoglobulin Therapy . METHODS : An open - label , multicenter , comparative , randomized study was conducted on COVID - 19 patients with moderate pneumonia . One hundred eligible patients were randomized in 1 : 1 ratio either to receive IVIG + standard of care ( SOC ) or SOC .
|
{
"P": [
"Coronavirus Disease 2019 Patients",
"COVID - 19 patients with moderate pneumonia",
"One hundred eligible patients"
],
"I": [
"Regular Intravenous Immunoglobulin Therapy",
"IVIG",
"standard of care ( SOC )"
],
"C": [
"SOC"
],
"O": []
}
|
Title : A Randomized Trial of Convalescent Plasma in Covid - 19 Severe Pneumonia . METHODS : We randomly assigned hospitalized adult patients with severe Covid - 19 pneumonia in a 2 : 1 ratio to receive convalescent plasma or placebo . The primary outcome was the patient ' s clinical status 30 days after the intervention , as measured on a six - point ordinal scale ranging from total recovery to death .
|
{
"P": [
"hospitalized adult patients with severe Covid - 19 pneumonia"
],
"I": [
"Convalescent Plasma",
"convalescent plasma"
],
"C": [
"placebo"
],
"O": [
"the patient ' s clinical status",
"a six - point ordinal scale"
]
}
|
Title : SARS - CoV - 2 clearance in COVID - 19 patients with Novaferon treatment : A randomized , open - label , parallel - group trial . METHODS : In the laboratory , Novaferon ' s inhibition of viral replication in cells infected with SARS - CoV - 2 , and prevention of SARS - CoV - 2 entry into healthy cells was determined . Antiviral effects of Novaferon in COVID - 19 patients with treatment of Novaferon , Novaferon plus Lopinavir / Ritonavir , or Lopinavir / Ritonavir were evaluated . The primary endpoint was the SARS - CoV - 2 clearance rates on day six of treatment , and the secondary endpoint was the time to SARS - CoV - 2 clearance .
|
{
"P": [
"COVID - 19 patients"
],
"I": [
"Novaferon",
"Lopinavir",
"Ritonavir"
],
"C": [],
"O": [
"the SARS - CoV - 2 clearance rates",
"the time to SARS - CoV - 2 clearance"
]
}
|
Title : Effect of a Single High Dose of Vitamin D3 on Hospital Length of Stay in Patients With Moderate to Severe COVID - 19 : A Randomized Clinical Trial . METHODS : This was a multicenter , double - blind , randomized , placebo - controlled trial conducted in 2 sites in Sao Paulo , Brazil . The study included 240 hospitalized patients with COVID - 19 who were moderately to severely ill at the time of enrollment from June 2 , 2020 , to August 27 , 2020 . The final follow - up was on October 7 , 2020 . Patients were randomly assigned to receive a single oral dose of 200 000 IU of vitamin D3 ( n = 120 ) or placebo ( n = 120 ) . The primary outcome was length of stay , defined as the time from the date of randomization to hospital discharge . Prespecified secondary outcomes included mortality during hospitalization ; the number of patients admitted to the intensive care unit ; the number of patients who required mechanical ventilation and the duration of mechanical ventilation ; and serum levels of 25 - hydroxyvitamin D , total calcium , creatinine , and C - reactive protein .
|
{
"P": [
"Patients With Moderate to Severe COVID - 19",
"240 hospitalized patients with COVID - 19 who were moderately to severely ill at the time of enrollment from June 2 , 2020 , to August 27 , 2020 . The final follow - up was on October 7 , 2020"
],
"I": [
"a Single High Dose of Vitamin D3",
"a single oral dose of 200 000 IU of vitamin D3"
],
"C": [
"placebo"
],
"O": [
"length of stay",
"the time from the date of randomization to hospital discharge",
"mortality",
"the number of patients admitted to the intensive care unit",
"the number of patients who required mechanical ventilation",
"the duration of mechanical ventilation",
"serum levels of 25 - hydroxyvitamin D",
"total calcium",
"creatinine",
"C - reactive protein"
]
}
|
Title : Sofosbuvir and daclatasvir for the treatment of COVID - 19 outpatients : a double - blind , randomized controlled trial . METHODS : This was a randomized controlled clinical trial in outpatients with mild COVID - 19 . Patients were randomized into a treatment arm receiving sofosbuvir / daclatasvir plus hydroxychloroquine or a control arm receiving hydroxychloroquine alone . The primary endpoint of the trial was symptom alleviation after 7 days of follow - up . The secondary endpoint of the trial was hospital admission . Fatigue , dyspnoea and loss of appetite were investigated after 1 month of follow - up . This study is registered with the IRCT . ir under registration number IRCT20200403046926N1 .
|
{
"P": [
"COVID - 19 outpatients",
"outpatients with mild COVID - 19"
],
"I": [
"Sofosbuvir",
"daclatasvir",
"sofosbuvir",
"hydroxychloroquine"
],
"C": [
"hydroxychloroquine alone"
],
"O": [
"symptom alleviation",
"hospital admission",
"Fatigue",
"dyspnoea",
"loss of appetite"
]
}
|
Title : The Humanoid Robot Sil - Bot in a Cognitive Training Program for Community - Dwelling Elderly People with Mild Cognitive Impairment during the COVID - 19 Pandemic : A Randomized Controlled Trial . METHODS : A randomized controlled trial was conducted with 135 volunteers without cognitive impairment aged 60 years old or older . Participants were first randomized into two groups . One group consisted of 90 participants who would receive cognitive training and 45 who would not receive any training ( NI ) . The cognitive training group was randomly divided into two groups , 45 who received traditional cognitive training ( TCT ) and 45 who received robot - assisted cognitive training ( RACT ) . The training for both groups consisted of a daily 60 min session , twice a week for six weeks .
|
{
"P": [
"Community - Dwelling Elderly People with Mild Cognitive Impairment during the COVID - 19 Pandemic",
"135 volunteers without cognitive impairment aged 60 years old or older"
],
"I": [
"The Humanoid Robot Sil - Bot in a Cognitive Training Program",
"cognitive training",
"The cognitive training",
"robot - assisted cognitive training ( RACT )"
],
"C": [
"any training ( NI )",
"traditional cognitive training ( TCT )"
],
"O": []
}
|
Title : Effect of Dexamethasone on Days Alive and Ventilator - Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID - 19 : The CoDEX Randomized Clinical Trial . METHODS : Multicenter , randomized , open - label , clinical trial conducted in 41 intensive care units ( ICUs ) in Brazil . Patients with COVID - 19 and moderate to severe ARDS , according to the Berlin definition , were enrolled from April 17 to June 23 , 2020 . Final follow - up was completed on July 21 , 2020 . The trial was stopped early following publication of a related study before reaching the planned sample size of 350 patients . Twenty mg of dexamethasone intravenously daily for 5 days , 10 mg of dexamethasone daily for 5 days or until ICU discharge , plus standard care ( n =151 ) or standard care alone ( n = 148 ) . The primary outcome was ventilator - free days during the first 28 days , defined as being alive and free from mechanical ventilation . Secondary outcomes were all - cause mortality at 28 days , clinical status of patients at day 15 using a 6 - point ordinal scale ( ranging from 1 , not hospitalized to 6 , death ) , ICU - free days during the first 28 days , mechanical ventilation duration at 28 days , and Sequential Organ Failure Assessment ( SOFA ) scores ( range , 0 - 24 , with higher scores indicating greater organ dysfunction ) at 48 hours , 72 hours , and 7 days .
|
{
"P": [
"Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID - 19",
"Patients with COVID - 19 and moderate to severe ARDS , according to the Berlin definition"
],
"I": [
"Dexamethasone",
"Twenty mg of dexamethasone",
"10 mg of dexamethasone",
"standard care"
],
"C": [
"standard care alone"
],
"O": [
"ventilator - free days",
"being alive",
"free from mechanical ventilation",
"all - cause mortality",
"clinical status of patients",
"a 6 - point ordinal scale",
"ICU - free days",
"mechanical ventilation duration",
"Sequential Organ Failure Assessment ( SOFA ) scores"
]
}
|
Title : Rationale and design for the study of rivaroxaban to reduce thrombotic events , hospitalization and death in outpatients with COVID - 19 : The PREVENT - HD study . METHODS : PREVENT - HD is a double - blind , placebo - controlled , pragmatic , event - driven phase 3 trial to evaluate the efficacy and safety of rivaroxaban in symptomatic outpatients with laboratory - confirmed COVID - 19 at risk for thrombotic events , hospitalization , and death . Several challenges posed by the pandemic have necessitated innovative approaches to clinical trial design , start - up , and conduct . Participants are randomized in a 1 : 1 ratio , stratified by time from COVID - 19 confirmation , to either rivaroxaban 10 mg once daily or placebo for 35 days . The primary efficacy end point is a composite of symptomatic venous thromboembolism , myocardial infarction , ischemic stroke , acute limb ischemia , non - central nervous system systemic embolization , all - cause hospitalization , and all - cause mortality . The primary safety end point is fatal and critical site bleeding according to the International Society on Thrombosis and Haemostasis definition . Enrollment began in August 2020 and is expected to enroll approximately 4 , 000 participants to yield the required number of end point events .
|
{
"P": [
"outpatients with COVID - 19",
"symptomatic outpatients with laboratory - confirmed COVID - 19 at risk for thrombotic events , hospitalization , and death"
],
"I": [
"rivaroxaban"
],
"C": [
"placebo"
],
"O": [
"a composite of symptomatic venous thromboembolism",
"myocardial infarction",
"ischemic stroke",
"acute limb ischemia",
"non - central nervous system systemic embolization",
"all - cause hospitalization",
"all - cause mortality",
"fatal",
"critical site bleeding",
"the International Society on Thrombosis and Haemostasis definition"
]
}
|
Title : Traditional Chinese medicine shenhuang granule in patients with severe / critical COVID - 19 : A randomized controlled multicenter trial . METHODS : This was an open - label , multicenter , randomized , controlled clinical trial . At 4 medical centers , a total of 111 severe / critical patients were randomly assigned to receive Shenhuang Granule ( SHG group ) twice a day for 14 days , in addition to standard care , or to receive standard care alone ( Control group ) . The maximal follow up time was 75 days . The clinical endpoint was clinical improvement and mortality .
|
{
"P": [
"patients with severe / critical COVID - 19",
"a total of 111 severe / critical patients"
],
"I": [
"Traditional Chinese medicine shenhuang granule",
"Shenhuang Granule",
"SHG",
"standard care"
],
"C": [
"standard care alone"
],
"O": []
}
|
Title : Efficacy and safety of sofosbuvir / ledipasvir in treatment of patients with COVID - 19 ; A randomized clinical trial . METHODS : Among an open - label randomized clinical trial , 82 patients with mild to moderated COVID - 19 were assigned to receive either SOF / LDP 400 / 100 mg daily plus the standard of care ( SOF / LDP group , n=42 ) or the standard of care alone ( control group , n=40 ) for 10 days . Time to clinical response , rate of clinical response , duration of hospital and ICU stay and 14 - day mortality were assessed .
|
{
"P": [
"patients with COVID - 19",
"82 patients with mild to moderated COVID - 19"
],
"I": [
"sofosbuvir",
"ledipasvir",
"SOF",
"LDP",
"the standard of care"
],
"C": [
"the standard of care alone"
],
"O": [
"Time to clinical response",
"rate of clinical response",
"duration of hospital",
"ICU stay",
"14 - day mortality"
]
}
|
Title : Umbilical Cord - derived Mesenchymal Stem Cells modulate TNF and soluble TNF Receptor 2 ( sTNFR2 ) in COVID - 19 ARDS patients . METHODS : We analyzed plasma samples from subjects with COVID - 19 ARDS ( n=24 ) enrolled in a Phase 1 / 2 a randomized controlled trial of UC - MSC treatment . Plasma samples were obtained at Day 0 ( baseline , before UC - MSC or control infusion ) , and Day 6 post infusion . Plasma concentrations of sTNFR2 , TNF? , and TNF? were evaluated using a quantitative multiplex protein array .
|
{
"P": [
"COVID - 19 ARDS patients",
"subjects with COVID - 19 ARDS ( n=24 )"
],
"I": [
"Umbilical Cord - derived Mesenchymal Stem Cells",
"UC - MSC treatment"
],
"C": [],
"O": [
"Plasma concentrations of sTNFR2",
"TNF?",
"a quantitative multiplex protein array"
]
}
|
Title : Chloroquine nasal drops in asymptomatic & mild COVID - 19 : An exploratory randomized clinical trial . METHODS : This randomized clinical trial was done with a sample size of 60 . Reverse transcription - polymerase chain reaction ( RT - PCR ) confirmed asymptomatic patients or those with mild COVID - 19 illness [ National Early Warning Score ( NEWS ) ?4 ] were included . Patients were randomized in a 1 : 1 manner . Control arm ( standard supportive treatment , n=30 ) was compared with intervention arm ( n=30 ) of standard treatment plus CQN eye drops ( 0 . 03 % ) repurposed as nasal drops administered six times daily ( 0 . 5 ml / dose ) for 10 days . Outcome measures were adverse events and adherence ; clinical progression and outcomes were measured by NEWS ; sequential RT - PCR cycle threshold ( Ct ) values were also noted on days 0 , 3 , 7 and 10 .
|
{
"P": [
"Reverse transcription - polymerase chain reaction ( RT - PCR ) confirmed asymptomatic patients or those with mild COVID - 19 illness [ National Early Warning Score ( NEWS ) ?4 ]"
],
"I": [
"Chloroquine",
"standard treatment",
"CQN"
],
"C": [
"standard supportive treatment"
],
"O": [
"adverse events",
"adherence",
"clinical progression",
"NEWS",
"sequential RT - PCR cycle threshold ( Ct ) values"
]
}
|
Title : Favipiravir in the treatment of patients with SARS - CoV - 2 RNA recurrent positive after discharge : A multicenter , open - label , randomized trial . METHODS : This is a multicenter , open - label , randomized controlled trial in SARS - CoV - 2 RNA re - positive patients . Patients were randomly assigned in a 2 : 1 ratio to receive either favipiravir , in addition to standard care , or standard care alone . The primary outcome was time to achieve a consecutive twice ( at intervals of more than 24 h ) negative RT - PCR result for SARS - CoV - 2 RNA in nasopharyngeal swab and sputum sample .
|
{
"P": [
"patients with SARS - CoV - 2 RNA recurrent positive after discharge",
"SARS - CoV - 2 RNA re - positive patients"
],
"I": [
"Favipiravir",
"favipiravir",
"standard care"
],
"C": [
"standard care alone"
],
"O": [
"time to achieve a consecutive twice ( at intervals of more than 24 h ) negative RT - PCR result for SARS - CoV - 2 RNA in nasopharyngeal swab",
"sputum sample"
]
}
|
Title : Magnesium treatment on methylation changes of transmembrane serine protease 2 ( TMPRSS2 ) . METHODS : This study is nested within the Personalized Prevention of Colorectal Cancer Trial , a double - blind 2 2 factorial randomized controlled trial , which enrolled 250 participants from Vanderbilt University Medical Center .
|
{
"P": [
"250 participants from Vanderbilt University Medical Center"
],
"I": [
"Magnesium treatment"
],
"C": [],
"O": []
}
|
Title : Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID - 19 in Brazil ( COALITION II ) : a randomised clinical trial . METHODS : We did an open - label , randomised clinical trial at 57 centres in Brazil . We enrolled patients admitted to hospital with suspected or confirmed COVID - 19 and at least one additional severity criteria as follows : use of oxygen supplementation of more than 4 L / min flow ; use of high - flow nasal cannula ; use of non - invasive mechanical ventilation ; or use of invasive mechanical ventilation . Patients were randomly assigned ( 1 : 1 ) to azithromycin ( 500 mg via oral , nasogastric , or intravenous administration once daily for 10 days ) plus standard of care or to standard of care without macrolides . All patients received hydroxychloroquine ( 400 mg twice daily for 10 days ) because that was part of standard of care treatment in Brazil for patients with severe COVID - 19 . The primary outcome , assessed by an independent adjudication committee masked to treatment allocation , was clinical status at day 15 after randomisation , assessed by a six - point ordinal scale , with levels ranging from 1 to 6 and higher scores indicating a worse condition ( with odds ratio [ OR ] greater than 100 favouring the control group ) . The primary outcome was assessed in all patients in the intention - to - treat ( ITT ) population who had severe acute respiratory syndrome coronavirus 2 infection confirmed by molecular or serological testing before randomisation ( ie , modified ITT [ mITT ] population ) . Safety was assessed in all patients according to which treatment they received , regardless of original group assignment . This trial was registered at ClinicalTrials . gov , NCT04321278 .
|
{
"P": [
"patients admitted to the hospital with severe COVID - 19 in Brazil",
"patients admitted to hospital with suspected or confirmed COVID - 19"
],
"I": [
"Azithromycin",
"standard of care",
"azithromycin",
"hydroxychloroquine"
],
"C": [
"standard of care alone",
"standard of care",
"macrolides"
],
"O": [
"clinical status",
"a six - point ordinal scale"
]
}
|
Title : Effects of a 2 - Week 5000 IU versus 1000 IU Vitamin D3 Supplementation on Recovery of Symptoms in Patients with Mild to Moderate Covid - 19 : A Randomized Clinical Trial . METHODS : A total of 69 reverse transcriptase polymerase chain reaction ( RT - PCR ) SARS - CoV - 2 positive adults who were hospitalized for mild to moderate COVID - 19 disease were allocated to receive once daily for 2 weeks either 5000 IU oral vitamin D3 ( n = 36 , 21 males ; 15 females ) or 1000 IU oral vitamin D3 ( standard control ) ( n = 33 , 13 males ; 20 females ) . Anthropometrics were measured and blood samples were taken pre - and post - supplementation . Fasting blood glucose , lipids , serum 25 ( OH ) D , and inflammatory markers were measured . COVID - 19 symptoms were noted on admission and monitored until full recovery .
|
{
"P": [
"Patients with Mild to Moderate Covid - 19",
"A total of 69 reverse transcriptase polymerase chain reaction ( RT - PCR ) SARS - CoV - 2 positive adults who were hospitalized for mild to moderate COVID - 19 disease"
],
"I": [
"a 2 - Week 5000 IU",
"once daily for 2 weeks either 5000 IU oral vitamin D3"
],
"C": [
"1000 IU Vitamin D3 Supplementation",
"1000 IU oral vitamin D3"
],
"O": [
"Anthropometrics",
"Fasting blood glucose",
"lipids",
"serum 25 ( OH ) D",
"inflammatory markers",
"COVID - 19 symptoms"
]
}
|
Title : REGN - COV2 , a Neutralizing Antibody Cocktail , in Outpatients with Covid - 19 . METHODS : In this ongoing , double - blind , phase 1 - 3 trial involving nonhospitalized patients with Covid - 19 , we investigated two fully human , neutralizing monoclonal antibodies against severe acute respiratory syndrome coronavirus 2 ( SARS - CoV - 2 ) spike protein , used in a combined cocktail ( REGN - COV2 ) to reduce the risk of the emergence of treatment - resistant mutant virus . Patients were randomly assigned ( 1:1:1 ) to receive placebo , 2 . 4 g of REGN - COV2 , or 8 . 0 g of REGN - COV2 and were prospectively characterized at baseline for endogenous immune response against SARS - CoV - 2 ( serum antibody - positive or serum antibody - negative ) . Key end points included the time - weighted average change in viral load from baseline ( day 1 ) through day 7 and the percentage of patients with at least one Covid - 19 - related medically attended visit through day 29 . Safety was assessed in all patients .
|
{
"P": [
"Outpatients with Covid - 19",
"nonhospitalized patients with Covid - 19"
],
"I": [
"REGN - COV2",
"a Neutralizing Antibody Cocktail",
"a combined cocktail",
"2 . 4 g of REGN - COV2",
"8 . 0 g of REGN - COV2"
],
"C": [
"placebo"
],
"O": [
"viral load",
"the percentage of patients with at least one Covid - 19 - related medically attended visit"
]
}
|
Title : A Cluster - Randomized Trial of Hydroxychloroquine for Prevention of Covid - 19 . METHODS : We conducted an open - label , cluster - randomized trial involving asymptomatic contacts of patients with polymerase - chain - reaction ( PCR ) - confirmed Covid - 19 in Catalonia , Spain . We randomly assigned clusters of contacts to the hydroxychloroquine group ( which received the drug at a dose of 800 mg once , followed by 400 mg daily for 6 days ) or to the usual - care group ( which received no specific therapy ) . The primary outcome was PCR - confirmed , symptomatic Covid - 19 within 14 days . The secondary outcome was SARS - CoV - 2 infection , defined by symptoms compatible with Covid - 19 or a positive PCR test regardless of symptoms . Adverse events were assessed for up to 28 days .
|
{
"P": [
"asymptomatic contacts of patients with polymerase - chain - reaction ( PCR ) - confirmed Covid - 19 in Catalonia , Spain"
],
"I": [
"Hydroxychloroquine",
"the hydroxychloroquine"
],
"C": [
"the usual - care"
],
"O": [
"PCR - confirmed , symptomatic Covid - 19",
"SARS - CoV - 2 infection",
"symptoms compatible with Covid - 19",
"a positive PCR test regardless of symptoms",
"Adverse events"
]
}
|
Title : Baricitinib plus Remdesivir for Hospitalized Adults with Covid - 19 . METHODS : We conducted a double - blind , randomized , placebo - controlled trial evaluating baricitinib plus remdesivir in hospitalized adults with Covid - 19 . All the patients received remdesivir ( ?10 days ) and either baricitinib ( ?14 days ) or placebo ( control ) . The primary outcome was the time to recovery . The key secondary outcome was clinical status at day 15 .
|
{
"P": [
"Hospitalized Adults with Covid - 19",
"hospitalized adults with Covid - 19"
],
"I": [
"Baricitinib",
"Remdesivir",
"baricitinib",
"remdesivir"
],
"C": [
"placebo"
],
"O": [
"the time to recovery",
"clinical status"
]
}
|
Title : Feasibility and outcome of an online streamed yoga intervention on stress and wellbeing of people working from home during COVID - 19 . METHODS : A six - week pilot randomized controlled trial ( RCT ) yoga intervention was designed with yoga ( n = 26 ) and a wait - list control group ( n = 26 ) . A mixed two - way ANOVA was used to assess changes in standardised outcome measures at baseline and post - intervention . Likert and open - ended questions assessed enjoyment , acceptability and perceived benefits of the program , which were analysed thematically .
|
{
"P": [
"people working from home during COVID - 19"
],
"I": [
"an online streamed yoga intervention",
"yoga"
],
"C": [
"a wait - list control"
],
"O": [
"Likert",
"open - ended questions",
"enjoyment",
"acceptability",
"perceived benefits of the program"
]
}
|
Title : Progesterone in Addition to Standard of Care vs Standard of Care Alone in the Treatment of Men Hospitalized With Moderate to Severe COVID - 19 : A Randomized , Controlled Pilot Trial . METHODS : We conducted a pilot , randomized , open - label , controlled trial of subcutaneous progesterone in men hospitalized with confirmed moderate to severe COVID - 19 . Patients were randomly assigned to receive SOC plus progesterone ( 100 mg subcutaneously twice daily for up to 5 days ) or SOC alone . In addition to assessment of safety , the primary outcome was change in clinical status on day 7 . Length of hospital stay and number of days on supplemental oxygen were key secondary outcomes .
|
{
"P": [
"Men Hospitalized With Moderate to Severe COVID - 19",
"men hospitalized with confirmed moderate to severe COVID - 19"
],
"I": [
"Progesterone",
"Standard of Care",
"subcutaneous progesterone",
"SOC",
"progesterone"
],
"C": [
"Standard of Care Alone",
"SOC alone"
],
"O": [
"clinical status",
"Length of hospital stay",
"number of days on supplemental oxygen"
]
}
|
Title : Historically controlled comparison of glucocorticoids with or without tocilizumab versus supportive care only in patients with COVID - 19 - associated cytokine storm syndrome : results of the CHIC study . METHODS : From 1 April 2020 , patients with COVID - 19 - associated CSS , defined as rapid respiratory deterioration plus at least two out of three biomarkers with important elevations ( C - reactive protein > 100 mg / L ; ferritin > 900 g / L ; D - dimer > 1500 g / L ) , received high - dose intravenous methylprednisolone for 5 consecutive days ( 250 mg on day 1 followed by 80 mg on days 2 - 5 ) . If the respiratory condition had not improved sufficiently ( in 43 % ) , the interleukin - 6 receptor blocker tocilizumab ( 8 mg / kg body weight , single infusion ) was added on or after day 2 . Control patients with COVID - 19 - associated CSS ( same definition ) were retrospectively sampled from the pool of patients ( n=350 ) admitted between 7 March and 31 March , and matched one to one to treated patients on sex and age . The primary outcome was ?2 stages of improvement on a 7 - item WHO - endorsed scale for trials in patients with severe influenza pneumonia , or discharge from the hospital . Secondary outcomes were hospital mortality and mechanical ventilation .
|
{
"P": [
"patients with COVID - 19 - associated cytokine storm syndrome",
"patients with COVID - 19 - associated CSS , defined as rapid respiratory deterioration plus at least two out of three biomarkers with important elevations ( C - reactive protein > 100 mg / L ; ferritin > 900 g / L ; D - dimer > 1500 g / L )",
"patients with severe influenza pneumonia"
],
"I": [
"glucocorticoids",
"tocilizumab",
"high - dose intravenous methylprednisolone",
"the interleukin - 6 receptor blocker tocilizumab"
],
"C": [
"supportive care only"
],
"O": [
"a 7 - item WHO - endorsed scale",
"discharge from the hospital",
"hospital mortality",
"mechanical ventilation"
]
}
|
Title : The effect of online multimedia psychoeducational interventions on the resilience and perceived stress of hospitalized patients with COVID - 19 : a pilot cluster randomized parallel - controlled trial . METHODS : This was a pilot cluster randomized parallel - controlled trial with hospital wards as the units of randomization . Participants in this fully online trial were 50 consecutive patients who were hospitalized in 2 hospitals in Shiraz , after being diagnosed with COVID - 19 . Before the beginning of the intervention , four inpatient wards inside two of the hospitals were randomly assigned to either intervention or control conditions . All eligible participants in the wards allocated to the intervention condition received online multimedia psychoeducational interventions during the 2 weeks , whilst the patients in the wards allocated to the control condition were offered the opportunity to receive telephone - based psychological counseling if needed . Psychoeducational interventions mainly included cognitive - behavioural techniques , stress management techniques , mindfulness - based stress reduction and positive psychotherapy . The patients were assessed regarding resilience and perceived stress at baseline and after two weeks .
|
{
"P": [
"hospitalized patients with COVID - 19",
"50 consecutive patients who were hospitalized in 2 hospitals in Shiraz , after being diagnosed with COVID - 19"
],
"I": [
"online multimedia psychoeducational interventions",
"Psychoeducational interventions",
"cognitive - behavioural techniques",
"stress management techniques",
"mindfulness - based stress reduction",
"positive psychotherapy"
],
"C": [
"telephone - based psychological counseling"
],
"O": [
"resilience",
"perceived stress"
]
}
|
Title : Double - blind , Randomized , Placebo - controlled Trial With N - acetylcysteine for Treatment of Severe Acute Respiratory Syndrome Caused by Coronavirus Disease 2019 ( COVID - 19 ) . METHODS : This was a double - blind , randomized , placebo - controlled , single - center trial conducted at the Emergency Department of Hospital das Clnicas , So Paulo , Brazil , to determine whether NAC in high doses can avoid respiratory failure in patients with COVID - 19 . We enrolled 135 patients with severe COVID - 19 ( confirmed or suspected ) , with an oxyhemoglobin saturation < 94 % or respiratory rate > 24 breaths / minute . Patients were randomized to receive NAC 21 g ( ~ 300 mg / kg ) for 20 hours or dextrose 5 % . The primary endpoint was the need for mechanical ventilation . Secondary endpoints were time of mechanical ventilation , admission to the intensive care unit ( ICU ) , time in ICU , and mortality .
|
{
"P": [
"patients with COVID - 19",
"135 patients with severe COVID - 19 ( confirmed or suspected ) , with an oxyhemoglobin saturation < 94 % or respiratory rate > 24 breaths / minute"
],
"I": [
"N - acetylcysteine",
"NAC"
],
"C": [
"dextrose"
],
"O": [
"the need for mechanical ventilation",
"time of mechanical ventilation",
"admission to the intensive care unit ( ICU )",
"time in ICU",
"mortality"
]
}
|
Title : Early versus deferred anti - SARS - CoV - 2 convalescent plasma in patients admitted for COVID - 19 : A randomized phase II clinical trial .
|
{
"P": [
"patients admitted for COVID - 19"
],
"I": [
"Early",
"deferred anti - SARS - CoV - 2 convalescent plasma"
],
"C": [],
"O": []
}
|
Title : Azithromycin for community treatment of suspected COVID - 19 in people at increased risk of an adverse clinical course in the UK ( PRINCIPLE ) : a randomised , controlled , open - label , adaptive platform trial . METHODS : In this UK - based , primary care , open - label , multi - arm , adaptive platform randomised trial of interventions against COVID - 19 in people at increased risk of an adverse clinical course ( PRINCIPLE ) , we randomly assigned people aged 65 years and older , or 50 years and older with at least one comorbidity , who had been unwell for 14 days or less with suspected COVID - 19 , to usual care plus azithromycin 500 mg daily for three days , usual care plus other interventions , or usual care alone . The trial had two coprimary endpoints measured within 28 days from randomisation : time to first self - reported recovery , analysed using a Bayesian piecewise exponential , and hospital admission or death related to COVID - 19 , analysed using a Bayesian logistic regression model . Eligible participants with outcome data were included in the primary analysis , and those who received the allocated treatment were included in the safety analysis . The trial is registered with ISRCTN , ISRCTN86534580 .
|
{
"P": [
"people at increased risk of an adverse clinical course in the UK",
"people at increased risk of an adverse clinical course",
"people aged 65 years and older , or 50 years and older with at least one comorbidity , who had been unwell for 14 days or less with suspected COVID - 19"
],
"I": [
"Azithromycin",
"usual care",
"azithromycin",
"other interventions"
],
"C": [
"usual care alone"
],
"O": [
"time to first self - reported recovery",
"hospital admission",
"death related to COVID - 19"
]
}
|
Title : The impact of sofosbuvir / daclatasvir or ribavirin in patients with severe COVID - 19 . METHODS : Patients with a positive nasopharyngeal swab for SARS - CoV - 2 on RT - PCR or bilateral multi - lobar ground - glass opacity on their chest CT and signs of severe COVID - 19 were included . Subjects were divided into two arms with one arm receiving ribavirin and the other receiving sofosbuvir / daclatasvir . All participants also received the recommended national standard treatment which , at that time , was lopinavir / ritonavir and single - dose hydroxychloroquine . The primary endpoint was time from starting the medication until discharge from hospital with secondary endpoints of duration of ICU stay and mortality .
|
{
"P": [
"patients with severe COVID - 19",
"Patients with a positive nasopharyngeal swab for SARS - CoV - 2 on RT - PCR or bilateral multi - lobar ground - glass opacity on their chest CT and signs of severe COVID - 19"
],
"I": [
"sofosbuvir",
"daclatasvir",
"ribavirin",
"the recommended national standard treatment",
"lopinavir",
"ritonavir",
"single - dose hydroxychloroquine"
],
"C": [],
"O": [
"time from starting the medication until discharge from hospital",
"duration of ICU stay",
"mortality"
]
}
|
Title : Efficacy of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in treatment of COVID - 19 : A randomized controlled trial . METHODS : A total of 283 patients participated in this clinical trial , and participants were randomly assigned to receive either 1 ) Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules or 2 ) Linahua granules , both combined with western medicine , or 3 ) western medicine alone for 14 days . At the end of the trial , the improvement and resolution rates of clinical symptoms and the rate of patients who progressed to severe disease status were evaluated .
|
{
"P": [
"A total of 283 patients"
],
"I": [
"Huoxiang Zhengqi dropping pills",
"Lianhua Qingwen granules",
"Linahua granules",
"western medicine"
],
"C": [
"western medicine alone"
],
"O": [
"the improvement",
"resolution rates of clinical symptoms",
"the rate of patients who progressed to severe disease status"
]
}
|
Title : Effect of anakinra versus usual care in adults in hospital with COVID - 19 and mild - to - moderate pneumonia ( CORIMUNO - ANA - 1 ) : a randomised controlled trial . METHODS : In this multicentre , open - label , Bayesian randomised clinical trial ( CORIMUNO - ANA - 1 ) , nested within the CORIMUNO - 19 cohort , we recruited patients from 16 University hospitals in France with mild - to - moderate COVID - 19 pneumonia , severe acute respiratory syndrome coronavirus 2 infection confirmed by real - time RT - PCR , requiring at least 3 L / min of oxygen by mask or nasal cannula but without ventilation assistance , a score of 5 on the WHO Clinical Progression Scale ( WHO - CPS ) , and a C - reactive protein serum concentration of more than 25 mg / L not requiring admission to the intensive care unit at admission to hospital . Eligible patients were randomly assigned ( 1 : 1 ) using a web - based secure centralised system , stratified by centre and blocked with varying block sizes ( randomly of size two or four ) , to either usual care plus anakinra ( 200 mg twice a day on days 1 - 3 , 100 mg twice on day 4 , 100 mg once on day 5 ) or usual care alone . Usual care was provided at the discretion of the site clinicians . The two coprimary outcomes were the proportion of patients who had died or needed non - invasive or mechanical ventilation by day 4 ( ie , a score of > 5 on the WHO - CPS ) and survival without need for mechanical or non - invasive ventilation ( including high - flow oxygen ) at day 14 . All analyses were done on an intention - to - treat basis . The trial is registered with ClinicalTrials . gov , NCT04341584 , and is now closed to accrual .
|
{
"P": [
"adults in hospital with COVID - 19 and mild - to - moderate pneumonia",
"patients from 16 University hospitals in France with mild - to - moderate COVID - 19 pneumonia , severe acute respiratory syndrome coronavirus 2 infection confirmed by real - time RT - PCR , requiring at least 3 L / min of oxygen by mask or nasal cannula but without ventilation assistance , a score of 5 on the WHO Clinical Progression Scale ( WHO - CPS ) , and a C - reactive protein serum concentration of more than 25 mg / L not requiring admission to the intensive care unit at admission to hospital"
],
"I": [
"anakinra",
"usual care"
],
"C": [
"usual care",
"usual care alone",
"Usual care"
],
"O": [
"the proportion of patients who had died",
"needed non - invasive",
"mechanical ventilation",
"survival without need for mechanical",
"non - invasive ventilation"
]
}
|
Title : Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019 : open label , randomised controlled trial . METHODS : Multicentre , open label , randomised controlled trial . 16 government designated covid - 19 treatment centres in China , 11 to 29 February 2020 . 150 patients admitted to hospital with laboratory confirmed covid - 19 were included in the intention to treat analysis ( 75 patients assigned to hydroxychloroquine plus standard of care , 75 to standard of care alone ) . Hydroxychloroquine administrated at a loading dose of 1200 mg daily for three days followed by a maintenance dose of 800 mg daily ( total treatment duration : two or three weeks for patients with mild to moderate or severe disease , respectively ) . Negative conversion of severe acute respiratory syndrome coronavirus 2 by 28 days , analysed according to the intention to treat principle . Adverse events were analysed in the safety population in which hydroxychloroquine recipients were participants who received at least one dose of hydroxychloroquine and hydroxychloroquine non - recipients were those managed with standard of care alone .
|
{
"P": [
"patients with mainly mild to moderate coronavirus disease 2019",
"150 patients admitted to hospital with laboratory confirmed covid - 19"
],
"I": [
"Hydroxychloroquine",
"hydroxychloroquine",
"standard of care",
"one dose of hydroxychloroquine"
],
"C": [
"standard of care alone"
],
"O": [
"Negative conversion of severe acute respiratory syndrome coronavirus 2",
"Adverse events"
]
}
|
Title : A two - arm , randomized , controlled , multi - centric , open - label phase - 2 study to evaluate the efficacy and safety of Itolizumab in moderate to severe ARDS patients due to COVID - 19 OBJECTTIVE : Efficacy and safety of Itolizumab , an immunomodulatory mAb , in treating moderate - to - severe acute respiratory distress syndrome ( ARDS ) due to cytokine release in COVID - 19 patients was evaluated in a multi - centric , open - label , two - arm , controlled , randomized , phase - 2 study . METHODS : Patients were randomized ( 2 : 1 ) to Arm - A ( best supportive care [ BSC ] + Itolizumab ) and Arm - B ( BSC ) . Primary outcome of interest was reduction in mortality 30 - days after enrollment .
|
{
"P": [
"moderate to severe ARDS patients due to COVID - 19"
],
"I": [
"Itolizumab",
"best supportive care [ BSC ]"
],
"C": [
"BSC"
],
"O": [
"mortality"
]
}
|
Title : Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID - 19 : The REMAP - CAP COVID - 19 Corticosteroid Domain Randomized Clinical Trial . METHODS : An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains , for example , antiviral agents , corticosteroids , or immunoglobulin . Between March 9 and June 17 , 2020 , 614 adult patients with suspected or confirmed COVID - 19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit ( ICU ) for respiratory or cardiovascular organ support at 121 sites in 8 countries . Of these , 403 were randomized to open - label interventions within the corticosteroid domain . The domain was halted after results from another trial were released . Follow - up ended August 12 , 2020 . The corticosteroid domain randomized participants to a fixed 7 - day course of intravenous hydrocortisone ( 50 mg or 100 mg every 6 hours ) ( n = 143 ) , a shock - dependent course ( 50 mg every 6 hours when shock was clinically evident ) ( n = 152 ) , or no hydrocortisone ( n = 108 ) . The primary end point was organ support - free days ( days alive and free of ICU - based respiratory or cardiovascular support ) within 21 days , where patients who died were assigned - 1 day . The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID - 19 , adjusting for age , sex , site , region , time , assignment to interventions within other domains , and domain and intervention eligibility . Superiority was defined as the posterior probability of an odds ratio greater than 1 ( threshold for trial conclusion of superiority > 99 % ) .
|
{
"P": [
"Patients With Severe COVID - 19",
"614 adult patients with suspected or confirmed COVID - 19"
],
"I": [
"Hydrocortisone",
"a fixed 7 - day course of intravenous hydrocortisone",
"a shock - dependent course"
],
"C": [
"no hydrocortisone"
],
"O": [
"organ support - free days",
"days alive",
"free of ICU - based respiratory",
"cardiovascular support"
]
}
|
Title : Effect of Helmet Noninvasive Ventilation vs High - Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID - 19 and Moderate to Severe Hypoxemic Respiratory Failure : The HENIVOT Randomized Clinical Trial . METHODS : Multicenter randomized clinical trial in 4 intensive care units ( ICUs ) in Italy between October and December 2020 , end of follow - up February 11 , 2021 , including 109 patients with COVID - 19 and moderate to severe hypoxemic respiratory failure ( ratio of partial pressure of arterial oxygen to fraction of inspired oxygen ?200 ) . Participants were randomly assigned to receive continuous treatment with helmet noninvasive ventilation ( positive end - expiratory pressure , 10 - 12 cm H2O ; pressure support , 10 - 12 cm H2O ) for at least 48 hours eventually followed by high - flow nasal oxygen ( n = 54 ) or high - flow oxygen alone ( 60 L / min ) ( n = 55 ) . The primary outcome was the number of days free of respiratory support within 28 days after enrollment . Secondary outcomes included the proportion of patients who required endotracheal intubation within 28 days from study enrollment , the number of days free of invasive mechanical ventilation at day 28 , the number of days free of invasive mechanical ventilation at day 60 , in - ICU mortality , in - hospital mortality , 28 - day mortality , 60 - day mortality , ICU length of stay , and hospital length of stay .
|
{
"P": [
"Patients With COVID - 19 and Moderate to Severe Hypoxemic Respiratory Failure",
"109 patients with COVID - 19 and moderate to severe hypoxemic respiratory failure ( ratio of partial pressure of arterial oxygen to fraction of inspired oxygen ?200 )"
],
"I": [
"Helmet Noninvasive Ventilation",
"High - Flow Nasal Oxygen",
"continuous treatment with helmet noninvasive ventilation",
"high - flow nasal oxygen",
"high - flow oxygen alone"
],
"C": [],
"O": [
"the number of days free of respiratory support",
"the proportion of patients who required endotracheal intubation",
"the number of days free of invasive mechanical ventilation",
"in - ICU mortality",
"in - hospital mortality",
"28 - day mortality",
"60 - day mortality",
"ICU length of stay",
"hospital length of stay"
]
}
|
Title : Randomized clinical trial " olfactory dysfunction after COVID - 19 : olfactory rehabilitation therapy vs . intervention treatment with Palmitoylethanolamide and Luteolin " : preliminary results . METHODS : We conducted a randomized - controlled pilot study in outpatients with history of confirmed COVID - 19 with post - infection olfactory impairment that persisted ? 90 days after SARS - CoV - 2 negative testing . Patients were randomized to two times a day olfactory rehabilitation alone or weekly olfactory rehabilitation plus daily oral supplement with PEA and Luteolin . Subjects with preexisting olfactory disorders were excluded . Sniffin ' Sticks assessments were performed at baseline and 30 days after treatment . Data on gender , age , and time since infection were collected . Kruskal - Wallis ( KW ) test was used to compare variances of Sniff scores between groups over time , and Spearman ' s correlation coefficients were calculated to assess for correlations between Sniff Score and gender or duration of infection .
|
{
"P": [
"outpatients with history of confirmed COVID - 19 with post - infection olfactory impairment that persisted ? 90 days after SARS - CoV - 2 negative testing"
],
"I": [
"Palmitoylethanolamide",
"Luteolin",
"weekly olfactory rehabilitation",
"daily oral supplement with PEA"
],
"C": [
"olfactory rehabilitation therapy",
"two times a day olfactory rehabilitation alone"
],
"O": [
"Sniffin ' Sticks assessments"
]
}
|
Title : Tocilizumab combined with favipiravir in the treatment of COVID - 19 : A multicenter trial in a small sample size . METHODS : This was a multicenter trial in adults with COVID - 19 . Patients were randomly assigned ( 3:1:1 ) to a 14 - day combination of favipiravir combined with tocilizumab ( combination group ) , favipiravir , and tocilizumab . The primary outcome was the cumulative lung lesion remission rate ( lung CT examination indicated absorption of lung inflammation ) .
|
{
"P": [
"adults with COVID - 19"
],
"I": [
"Tocilizumab",
"favipiravir",
"a 14 - day combination of favipiravir",
"tocilizumab"
],
"C": [],
"O": [
"the cumulative lung lesion remission rate",
"lung CT examination indicated absorption of lung inflammation"
]
}
|
Title : Discontinuation versus continuation of renin - angiotensin - system inhibitors in COVID - 19 ( ACEI - COVID ) : a prospective , parallel group , randomised , controlled , open - label trial . METHODS : ACEI - COVID was a parallel group , randomised , controlled , open - label trial done at 35 centres in Austria and Germany . Patients aged 18 years and older were enrolled if they presented with recent symptomatic SARS - CoV - 2 infection and were chronically treated with ACEIs or ARBs . Patients were randomly assigned 1 : 1 to discontinuation or continuation of RAS inhibition for 30 days . Primary outcome was the maximum sequential organ failure assessment ( SOFA ) score within 30 days , where death was scored with the maximum achievable SOFA score . Secondary endpoints were area under the death - adjusted SOFA score ( AUCSOFA ) , mean SOFA score , admission to the intensive care unit , mechanical ventilation , and death . Analyses were done on a modified intention - to - treat basis . This trial is registered with ClinicalTrials . gov , NCT04353596 .
|
{
"P": [
"Patients aged 18 years and older"
],
"I": [
"Discontinuation",
"continuation of renin - angiotensin - system inhibitors",
"discontinuation",
"continuation of RAS inhibition"
],
"C": [],
"O": [
"the maximum sequential organ failure assessment ( SOFA ) score",
"area under the death - adjusted SOFA score ( AUCSOFA )",
"mean SOFA score",
"admission to the intensive care unit",
"mechanical ventilation",
"death"
]
}
|
Title : [ Effect of Xuebijing injection on inflammatory markers and disease outcome of coronavirus disease 2019 ] . METHODS : Sixty severe COVID - 19 patients admitted to Changsha Public Health Treatment Center ( North Hospital of the First Hospital of Changsha City ) from January to March in 2020 were randomly divided into routine treatment group , Xuebijing 50 mL group and Xuebijing 100 mL group , with 20 cases in each group . The routine treatment group was treated according to the National Health Commission ' s guide for COVID - 19 . On the basis of conventional treatment , Xuebijing injection was injected by 50 mL twice a day for 7 days in Xuebijing 50 mL group , while by 100 mL twice a day for 7 days in Xuebijing 100 mL group . The blood routine test , C - reactive protein ( CRP ) , erythrocyte sedimentation rate ( ESR ) , acute physiology and chronic health evaluation II ( APACHE II ) score , 2019 novel coronavirus ( 2019 - nCoV ) nucleic acid test and disease classification of three groups before and 8 days after treatment were observed .
|
{
"P": [
"Sixty severe COVID - 19 patients admitted to Changsha Public Health Treatment Center ( North Hospital of the First Hospital of Changsha City ) from January to March in 2020"
],
"I": [
"Xuebijing injection",
"Xuebijing"
],
"C": [
"routine treatment"
],
"O": [
"The blood routine test",
"C - reactive protein ( CRP )",
"erythrocyte sedimentation rate ( ESR )",
"acute physiology",
"chronic health evaluation II ( APACHE II ) score",
"2019 novel coronavirus ( 2019 - nCoV ) nucleic acid test",
"disease classification"
]
}
|
Title : Ruxolitinib in treatment of severe coronavirus disease 2019 ( COVID - 19 ) : A multicenter , single - blind , randomized controlled trial . METHODS : We conducted a prospective , multicenter , single - blind , randomized controlled phase II trial involving patients with severe coronavirus disease 2019 .
|
{
"P": [
"patients with severe coronavirus disease 2019"
],
"I": [
"Ruxolitinib"
],
"C": [],
"O": []
}
|
Title : Dexamethasone vs methylprednisolone high dose for Covid - 19 pneumonia . METHODS : Ambispective cohort study with survival analysis of 216 patients diagnosed with severe Covid - 19 pneumonia confirmed by polymerase chain reaction for SARS - CoV2 by Berlin protocol , who were hospitalized in a high - complexity clinic in Medelln , Colombia . The patients should also have supplementary oxygen and radiological confirmation of Pneumonia by chest tomography . Sample size was not calculated since the total population that met the inclusion criteria was evaluated . 111 patients were treated with the institutional protocol with intravenous dexamethasone 6 mg QD for seven to 10 days if they required oxygen . Since September 15 , 2020 , the hospitalization protocol of the clinic was modified by the Infectious Diseases and Pulmonology service , recommending a high dose of methylprednisolone of 250 to 500 mg every day for three days with a subsequent change to oral prednisone 50 mg every day for 14 days . The protocol was not applied in the intensive care unit , where dexamethasone continued to be administered . The clinical outcome and differences in laboratory results of the patients who received dexamethasone vs . the prospective cohort that received methylprednisolone from September 15 to October 31 , 2020 , were evaluated . Follow - up was carried out by outpatient consultation one month after discharge or by telephone , inquiring about readmission or living - dead status .
|
{
"P": [
"216 patients diagnosed with severe Covid - 19 pneumonia confirmed by polymerase chain reaction for SARS - CoV2 by Berlin protocol , who were hospitalized in a high - complexity clinic in Medelln , Colombia"
],
"I": [
"Dexamethasone",
"methylprednisolone",
"intravenous dexamethasone",
"a high dose of methylprednisolone",
"dexamethasone"
],
"C": [],
"O": [
"The clinical outcome",
"laboratory results",
"readmission",
"living - dead status"
]
}
|
Title : Triple combination of interferon beta - 1 b , lopinavir - ritonavir , and ribavirin in the treatment of patients admitted to hospital with COVID - 19 : an open - label , randomised , phase 2 trial . METHODS : This was a multicentre , prospective , open - label , randomised , phase 2 trial in adults with COVID - 19 who were admitted to six hospitals in Hong Kong . Patients were randomly assigned ( 2 : 1 ) to a 14 - day combination of lopinavir 400 mg and ritonavir 100 mg every 12 h , ribavirin 400 mg every 12 h , and three doses of 8 million international units of interferon beta - 1 b on alternate days ( combination group ) or to 14 days of lopinavir 400 mg and ritonavir 100 mg every 12 h ( control group ) . The primary endpoint was the time to providing a nasopharyngeal swab negative for severe acute respiratory syndrome coronavirus 2 RT - PCR , and was done in the intention - to - treat population . The study is registered with ClinicalTrials . gov , NCT04276688 .
|
{
"P": [
"patients admitted to hospital with COVID - 19",
"adults with COVID - 19 who were admitted to six hospitals in Hong Kong"
],
"I": [
"interferon beta - 1 b",
"lopinavir",
"ritonavir",
"ribavirin",
"a 14 - day combination of lopinavir",
"three doses of 8 million international units of interferon beta - 1 b"
],
"C": [
"14 days of lopinavir",
"ritonavir"
],
"O": [
"the time to providing a nasopharyngeal swab negative for severe acute respiratory syndrome coronavirus 2 RT - PCR"
]
}
|
Title : Effect of Intermediate - Dose vs Standard - Dose Prophylactic Anticoagulation on Thrombotic Events , Extracorporeal Membrane Oxygenation Treatment , or Mortality Among Patients With COVID - 19 Admitted to the Intensive Care Unit : The INSPIRATION Randomized Clinical Trial . METHODS : Multicenter randomized trial with a 2 O 2 factorial design performed in 10 academic centers in Iran comparing intermediate - dose vs standard - dose prophylactic anticoagulation ( first hypothesis ) and statin therapy vs matching placebo ( second hypothesis ; not reported in this article ) among adult patients admitted to the ICU with COVID - 19 . Patients were recruited between July 29 , 2020 , and November 19 , 2020 . The final follow - up date for the 30 - day primary outcome was December 19 , 2020 . Intermediate - dose ( enoxaparin , 1 mg / kg daily ) ( n = 276 ) vs standard prophylactic anticoagulation ( enoxaparin , 40 mg daily ) ( n = 286 ) , with modification according to body weight and creatinine clearance . The assigned treatments were planned to be continued until completion of 30 - day follow - up . The primary efficacy outcome was a composite of venous or arterial thrombosis , treatment with extracorporeal membrane oxygenation , or mortality within 30 days , assessed in randomized patients who met the eligibility criteria and received at least 1 dose of the assigned treatment . Prespecified safety outcomes included major bleeding according to the Bleeding Academic Research Consortium ( type 3 or 5 definition ) , powered for noninferiority ( a noninferiority margin of 1 . 8 based on odds ratio ) , and severe thrombocytopenia ( platelet count < 20 103 / L ) . All outcomes were blindly adjudicated .
|
{
"P": [
"Patients With COVID - 19 Admitted to the Intensive Care Unit",
"adult patients admitted to the ICU with COVID - 19"
],
"I": [
"Intermediate - Dose",
"intermediate - dose",
"statin therapy",
"Intermediate - dose ( enoxaparin"
],
"C": [
"Standard - Dose Prophylactic Anticoagulation",
"standard - dose prophylactic anticoagulation",
"matching placebo",
"standard prophylactic anticoagulation ( enoxaparin"
],
"O": [
"a composite of venous",
"arterial thrombosis",
"treatment with extracorporeal membrane oxygenation",
"mortality",
"major bleeding",
"the Bleeding Academic Research Consortium ( type 3 or 5 definition )",
"powered for noninferiority",
"severe thrombocytopenia"
]
}
|
Title : Early Use of Corticosteroid May Prolong SARS - CoV - 2 Shedding in Non - Intensive Care Unit Patients with COVID - 19 Pneumonia : A Multicenter , Single - Blind , Randomized Control Trial . METHODS : This was a prospective , multicenter , single - blind , randomized control trial . Adult patients with COVID - 19 pneumonia who were admitted to the general ward were randomly assigned to either receive methylprednisolone or not for 7 days . The primary end point was the incidence of clinical deterioration 14 days after randomization .
|
{
"P": [
"Non - Intensive Care Unit Patients with COVID - 19 Pneumonia",
"Adult patients with COVID - 19 pneumonia who were admitted to the general ward"
],
"I": [
"Corticosteroid",
"methylprednisolone"
],
"C": [
"not"
],
"O": [
"the incidence of clinical deterioration"
]
}
|
Title : [ Observation of therapeutic effect on coronavirus disease 2019 with insomnia in treatment with baduanjin and auricular point sticking therapy ] . METHODS : A total of 90 patients with COVID - 19 accompanied with insomnia were randomly divided into an observation group ( 45 cases , 3 cases dropped off ) and a control group ( 45 cases ) . In the observation group , baduanjin , a traditional Chinese fitness activity , was practiced everyday . Besides , auricular point sticking therapy was exerted at ear - shenmen ( TF 4 ) , subcortex ( AT 4 ) , heart ( CO 15 ) , occiput ( AT 3 ) , etc . These auricular points were pressed and kneaded three times a day , 30 s at each point each time , consecutively for 12 days . In the control group , estazolam tablets were prescribed for oral administration , 1 mg , once daily , consecutively for 12 days . Before and after treatment , the score of Pittsburgh sleep quality index ( PSQI ) , the score of self - rating anxiety scale ( SAS ) , the score of self - rating depression scale ( SDS ) and the score of symptoms in traditional Chinese medicine ( TCM ) were observed in the two groups and the clinical therapeutic effect was evaluated .
|
{
"P": [
"A total of 90 patients with COVID - 19 accompanied with insomnia"
],
"I": [
"baduanjin",
"auricular point sticking therapy",
"a traditional Chinese fitness activity"
],
"C": [
"estazolam"
],
"O": [
"the score of Pittsburgh sleep quality index ( PSQI )",
"the score of self - rating anxiety scale ( SAS )",
"the score of self - rating depression scale ( SDS )",
"the score of symptoms in traditional Chinese medicine ( TCM )"
]
}
|
Title : Sarilumab in patients admitted to hospital with severe or critical COVID - 19 : a randomised , double - blind , placebo - controlled , phase 3 trial . METHODS : We did a 60 - day , randomised , double - blind , placebo - controlled , multinational phase 3 trial at 45 hospitals in Argentina , Brazil , Canada , Chile , France , Germany , Israel , Italy , Japan , Russia , and Spain . We included adults ( ?18 years ) admitted to hospital with laboratory - confirmed SARS - CoV - 2 infection and pneumonia , who required oxygen supplementation or intensive care . Patients were randomly assigned ( 2:2:1 with permuted blocks of five ) to receive intravenous sarilumab 400 mg , sarilumab 200 mg , or placebo . Patients , care providers , outcome assessors , and investigators remained masked to assigned intervention throughout the course of the study . The primary endpoint was time to clinical improvement of two or more points ( seven point scale ranging from 1 [ death ] to 7 [ discharged from hospital ] ) in the modified intention - to - treat population . The key secondary endpoint was proportion of patients alive at day 29 . Safety outcomes included adverse events and laboratory assessments . This study is registered with ClinicalTrials . gov , NCT04327388 ; EudraCT , 2020-001162-12 ; and WHO , U1111 - 1249 - 6021 .
|
{
"P": [
"patients admitted to hospital with severe or critical COVID - 19",
"adults ( ?18 years ) admitted to hospital with laboratory - confirmed SARS - CoV - 2 infection and pneumonia , who required oxygen supplementation or intensive care"
],
"I": [
"Sarilumab",
"intravenous sarilumab",
"sarilumab"
],
"C": [
"placebo"
],
"O": [
"time to clinical improvement of two",
"more points",
"proportion of patients alive",
"adverse events",
"laboratory assessments"
]
}
|
Title : The CABI Trial : an Unblinded Parallel Group Randomised Controlled Feasibility Trial of Long - Course Antibiotic Therapy ( 28 Days ) Compared with Short Course ( ? 10 Days ) in the Prevention of Relapse in Adults Treated for Complicated Intra - Abdominal Infection . METHODS : A randomised controlled unblinded feasibility trial was conducted . Eligible participants were adult patients with a cIAI that were diagnosed ? 6 days prior to screening . Randomisation was to long - course ( 28 days ) or short - course ( ?10 days ) antibiotic therapy . Choice of antibiotics was determined by the clinical team . Participants were followed up for 90 days . Primary outcomes were willingness of participants to be randomised and feasibility of trial procedures .
|
{
"P": [
"Adults Treated for Complicated Intra - Abdominal Infection",
"adult patients with a cIAI that were diagnosed ? 6 days prior to screening"
],
"I": [
"Long - Course Antibiotic Therapy",
"Short Course",
"long - course",
"short - course ( ?10 days ) antibiotic therapy"
],
"C": [],
"O": [
"willingness of participants to be randomised",
"feasibility of trial procedures"
]
}
|
Title : Inhaled budesonide for COVID - 19 in people at high risk of complications in the community in the UK ( PRINCIPLE ) : a randomised , controlled , open - label , adaptive platform trial . METHODS : PRINCIPLE is a multicentre , open - label , multi - arm , randomised , controlled , adaptive platform trial done remotely from a central trial site and at primary care centres in the UK . Eligible participants were aged 65 years or older or 50 years or older with comorbidities , and unwell for up to 14 days with suspected COVID - 19 but not admitted to hospital . Participants were randomly assigned to usual care , usual care plus inhaled budesonide ( 800 ?g twice daily for 14 days ) , or usual care plus other interventions , and followed up for 28 days . Participants were aware of group assignment . The coprimary endpoints are time to first self - reported recovery and hospital admission or death related to COVID - 19 , within 28 days , analysed using Bayesian models . The primary analysis population included all eligible SARS - CoV - 2 - positive participants randomly assigned to budesonide , usual care , and other interventions , from the start of the platform trial until the budesonide group was closed . This trial is registered at the ISRCTN registry ( ISRCTN86534580 ) and is ongoing .
|
{
"P": [
"COVID - 19 in people at high risk of complications in the community in the UK",
"aged 65 years or older or 50 years or older with comorbidities , and unwell for up to 14 days with suspected COVID - 19 but not admitted to hospital"
],
"I": [
"Inhaled budesonide",
"usual care",
"inhaled budesonide",
"other interventions",
"budesonide",
"the budesonide"
],
"C": [
"usual care"
],
"O": [
"time to first self - reported recovery",
"hospital admission",
"death related to COVID - 19"
]
}
|
Title : Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection ( COVID - 19 ) : a randomized controlled trial . METHODS : This was an open - label , multicentre , randomized controlled clinical trial in adults with moderate or severe COVID - 19 admitted to four university hospitals in Iran . Patients were randomized into a treatment arm receiving sofosbuvir and daclatasvir plus standard care , or a control arm receiving standard care alone . The primary endpoint was clinical recovery within 14 days of treatment . The study is registered with IRCT . ir under registration number IRCT20200128046294N2 .
|
{
"P": [
"patients admitted to hospital with moderate or severe coronavirus infection ( COVID - 19 )",
"adults with moderate or severe COVID - 19 admitted to four university hospitals in Iran"
],
"I": [
"Sofosbuvir",
"daclatasvir",
"sofosbuvir",
"standard care"
],
"C": [
"standard of care",
"standard care alone"
],
"O": [
"clinical recovery"
]
}
|
Title : [ Effect of moxibustion on clinical symptoms , peripheral inflammatory indexes and T lymphocyte subsets in COVID - 19 patients ] . METHODS : A total of 95 patients with COVID - 19 were randomly divided into a moxibustion group ( 45 cases ) and a basic treatment group ( 50 cases ) . The routine treatment of western medicine was applied in the patients of both groups . In the moxibustion group , on the base of the treatment of western medicine , moxibustion was applied to Dazhui ( GV 14 ) , Feishu ( BL 13 ) , Qihai ( CV 6 ) and Zusanli ( ST 36 ) , once daily and consecutively for 14 days . At the end of treatment courses , clinical symptom scores for cough , asthmatic breathing , chest oppression and short breath , as well as their remission rates were compared between the two groups before and after treatment . Before and after treatment , the white blood cell ( WBC ) count , the levels of c - reactive protein ( CRP ) and interleukin - 6 ( IL - 6 ) and the absolute number of T lymphocyte subsets , i . e . , and of the peripheral blood were compared in the patients between the two groups . The principal component analysis was adopted to analyze the common data extracted from the above 10 clinical indexes variables and comprehensively evaluate the differences in the therapeutic effect of two regimens .
|
{
"P": [
"COVID - 19 patients",
"A total of 95 patients with COVID - 19"
],
"I": [
"moxibustion",
"a moxibustion",
"the moxibustion"
],
"C": [],
"O": [
"clinical symptom scores for cough",
"asthmatic breathing",
"chest oppression",
"short breath",
"their remission rates",
"the white blood cell ( WBC ) count",
"the levels of c - reactive protein ( CRP )",
"interleukin - 6 ( IL - 6 )",
"the absolute number of T lymphocyte subsets",
"the peripheral blood"
]
}
|
Title : Peginterferon lambda for the treatment of outpatients with COVID - 19 : a phase 2 , placebo - controlled randomised trial . METHODS : In this double - blind , placebo - controlled trial , outpatients with laboratory - confirmed COVID - 19 were randomly assigned to a single subcutaneous injection of peginterferon lambda 180 ?g or placebo within 7 days of symptom onset or first positive swab if asymptomatic . Participants were randomly assigned ( 1 : 1 ) using a computer - generated randomisation list created with a randomisation schedule in blocks of four . At the time of administration , study nurses received a sealed opaque envelope with the treatment allocation number . The primary endpoint was the proportion of patients who were negative for severe acute respiratory syndrome coronavirus 2 ( SARS - CoV - 2 ) RNA on day 7 after the injection , analysed by a ?2 test following an intention - to - treat principle . Prespecified analysis of the primary endpoint , adjusted for baseline viral load , using bivariate logistic regression was done . The trial is now complete . This trial is registered with ClinicalTrials . gov , NCT04354259 .
|
{
"P": [
"outpatients with COVID - 19",
"outpatients with laboratory - confirmed COVID - 19"
],
"I": [
"Peginterferon lambda",
"peginterferon lambda"
],
"C": [
"placebo"
],
"O": [
"the proportion of patients who were negative for severe acute respiratory syndrome coronavirus 2 ( SARS - CoV - 2 ) RNA",
"viral load"
]
}
|
Title : Randomised , controlled , open label , multicentre clinical trial to explore safety and efficacy of hyperbaric oxygen for preventing ICU admission , morbidity and mortality in adult patients with COVID - 19 . METHODS : A randomised , controlled , phase II , open label , multicentre trial . 200 subjects with severe COVID - 19 and at least two risk factors for mortality will be included . Baseline clinical data and blood samples will be collected before randomisation and repeated daily for 7 days , at days 14 and 30 . Subjects will be randomised with a computer - based system to HBO , maximum five times during the first 7 days plus best practice treatment or only best practice treatment . The primary endpoint , ICU admission , is defined by criteria for selection for ICU . We will evaluate if HBO mitigates the inflammatory reaction in COVID - 19 using molecular analyses . All parameters are recorded in an electronic case report form . An independent Data Safety Monitoring Board will review the safety parameters .
|
{
"P": [
"adult patients with COVID - 19",
"200 subjects with severe COVID - 19 and at least two risk factors for mortality"
],
"I": [
"hyperbaric oxygen",
"HBO",
"best practice treatment"
],
"C": [
"only best practice treatment"
],
"O": [
"ICU admission",
"criteria for selection for ICU",
"the inflammatory reaction in COVID - 19",
"the safety parameters"
]
}
|
Title : A randomized , open - label , adaptive , proof - of - concept clinical trial of modulation of host thromboinflammatory response in patients with COVID - 19 : the DAWn - Antico study . METHODS : In this adaptive , open - label multicenter randomized clinical trial , we compare low molecular weight heparins at 50 IU anti - Xa / kg twice daily - or 75 IU anti - Xa twice daily for intensive care ( ICU ) patients - in combination with aprotinin to standard thromboprophylaxis in hospitalized COVID - 19 patients . In the case of hyperinflammation , the interleukin - 1 receptor antagonist anakinra will be added on top of the drugs in the interventional arm . In a pilot phase , the effect of the intervention on thrombotic markers ( D - dimer ) will be assessed . In the full trial , the primary outcome is defined as the effect of the interventional drugs on clinical status as defined by the WHO ordinal scale for clinical improvement .
|
{
"P": [
"patients with COVID - 19",
"intensive care ( ICU ) patients",
"hospitalized COVID - 19 patients"
],
"I": [
"low molecular weight heparins",
"aprotinin",
"standard thromboprophylaxis"
],
"C": [],
"O": [
"thrombotic markers ( D - dimer )",
"clinical status",
"the WHO ordinal scale for clinical improvement"
]
}
|
Title : Nano - curcumin therapy , a promising method in modulating inflammatory cytokines in COVID - 19 patients . METHODS : Forty COVID - 19 patients and 40 healthy controls were recruited and evaluated for inflammatory cytokine expression and secretion . Subsequently , COVID - 19 patients were divided into two groups : 20 patients receiving Nano - curcumin and 20 patients as the placebo group . The mRNA expression and cytokine secretion levels of IL - 1? , IL - 6 , TNF - ? and IL - 18 were assessed by Real - time PCR and ELISA , respectively .
|
{
"P": [
"COVID - 19 patients",
"Forty COVID - 19 patients and 40 healthy controls"
],
"I": [
"Nano - curcumin therapy",
"Nano - curcumin"
],
"C": [
"the placebo"
],
"O": [
"The mRNA expression",
"cytokine secretion levels of IL - 1?",
"IL - 6",
"TNF - ?",
"IL - 18",
"Real - time PCR",
"ELISA"
]
}
|
Title : Efficacy of Brazilian green propolis ( EPP - AF ) as an adjunct treatment for hospitalized COVID - 19 patients : A randomized , controlled clinical trial . METHODS : In a randomized , controlled , open - label , single - center trial , hospitalized adult COVID - 19 patients were treated with a standardized green propolis extract ( EPP - AF? ) as an adjunct therapy . Patients were allocated to receive standard care plus an oral dose of 400 mg or 800 mg / day of green propolis for seven days , or standard care alone . Standard care included all necessary interventions , as determined by the attending physician . The primary end point was the time to clinical improvement , defined as the length of hospital stay or oxygen therapy dependency duration . Secondary outcomes included acute kidney injury and need for intensive care or vasoactive drugs . Patients were followed for 28 days after admission .
|
{
"P": [
"hospitalized COVID - 19 patients",
"hospitalized adult COVID - 19 patients"
],
"I": [
"Brazilian green propolis",
"EPP - AF",
"a standardized green propolis extract",
"EPP - AF?",
"standard care",
"an oral dose of 400 mg",
"800 mg / day of green propolis",
"Standard care"
],
"C": [
"standard care alone"
],
"O": [
"the time to clinical improvement",
"the length of hospital stay",
"oxygen therapy dependency duration",
"acute kidney injury",
"need for intensive care",
"vasoactive drugs"
]
}
|
Title : Remdesivir in adults with severe COVID - 19 : a randomised , double - blind , placebo - controlled , multicentre trial . METHODS : We did a randomised , double - blind , placebo - controlled , multicentre trial at ten hospitals in Hubei , China . Eligible patients were adults ( aged ?18 years ) admitted to hospital with laboratory - confirmed SARS - CoV - 2 infection , with an interval from symptom onset to enrolment of 12 days or less , oxygen saturation of 94 % or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less , and radiologically confirmed pneumonia . Patients were randomly assigned in a 2 : 1 ratio to intravenous remdesivir ( 200 mg on day 1 followed by 100 mg on days 2 - 10 in single daily infusions ) or the same volume of placebo infusions for 10 days . Patients were permitted concomitant use of lopinavir - ritonavir , interferons , and corticosteroids . The primary endpoint was time to clinical improvement up to day 28 , defined as the time ( in days ) from randomisation to the point of a decline of two levels on a six - point ordinal scale of clinical status ( from 1 = discharged to 6 = death ) or discharged alive from hospital , whichever came first . Primary analysis was done in the intention - to - treat ( ITT ) population and safety analysis was done in all patients who started their assigned treatment . This trial is registered with ClinicalTrials . gov , NCT04257656 .
|
{
"P": [
"adults with severe COVID - 19",
"adults ( aged ?18 years ) admitted to hospital with laboratory - confirmed SARS - CoV - 2 infection , with an interval from symptom onset to enrolment of 12 days or less , oxygen saturation of 94 % or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less , and radiologically confirmed pneumonia"
],
"I": [
"Remdesivir",
"intravenous remdesivir"
],
"C": [
"the same volume of placebo"
],
"O": [
"time to clinical improvement",
"the time ( in days ) from randomisation to the point of a decline of two levels",
"a six - point ordinal scale of clinical status",
"discharged alive from hospital"
]
}
|
Title : The use of oxygen hoods in patients failing on conventional high - flow oxygen delivery systems , the effects on oxygenation , mechanical ventilation and mortality rates in hypoxic patients with COVID - 19 . A Prospective Controlled Cohort Study . METHODS : DesignProspective Controlled Cohort Study . SettingSingle Center . ParticipantsAll patients admitted with a diagnosis of COVID - 19 were reviewed and 136 / 347 patients met inclusion criteria . Study period3 / 6 / 2020 to 5/1/2020 . 136 participants completed the study with known status for all outcome measures . Intervention or exposureOxygen hoods / helmets as compared to conventional high - flow oxygen delivery systems . 1 ) Pre and post change in oxygen saturation ( SaO2 ) . 2 ) In - hospital Mechanical Ventilation ( MV ) . 3 ) In - hospital Mortality . 4 ) Length of hospitalization .
|
{
"P": [
"patients failing on conventional high - flow oxygen delivery systems",
"hypoxic patients with COVID - 19",
"ParticipantsAll patients admitted with a diagnosis of COVID - 19"
],
"I": [
"oxygen hoods",
"exposureOxygen hoods",
"helmets"
],
"C": [
"conventional high - flow oxygen delivery systems"
],
"O": [
"oxygen saturation ( SaO2 )",
"In - hospital Mechanical Ventilation ( MV )",
"In - hospital Mortality",
"Length of hospitalization"
]
}
|
Title : Febuxostat therapy in outpatients with suspected COVID - 19 : A clinical trial . METHODS : We conducted a clinical trial involving adult outpatients with the moderate respiratory illness following COVID - 19 infection . Patients were randomly assigned to receive either FBX or HCQ for 5 days . The measured variables were needs to hospitalisation , clinical and laboratory data including fever , cough , breathing rate , C - Reactive Protein level , lymphocytes count at onset of admission and was well as at 5 days of treatments . In addition , CT findings were evaluated on admission and 14 days after initiation of treatment .
|
{
"P": [
"outpatients with suspected COVID - 19",
"adult outpatients with the moderate respiratory illness following COVID - 19 infection"
],
"I": [
"Febuxostat therapy",
"FBX",
"HCQ"
],
"C": [],
"O": [
"needs to hospitalisation",
"clinical",
"laboratory data",
"fever",
"cough",
"breathing rate",
"C - Reactive Protein level",
"lymphocytes count",
"CT findings"
]
}
|
Title : Methylprednisolone or dexamethasone , which one is superior corticosteroid in the treatment of hospitalized COVID - 19 patients : a triple - blinded randomized controlled trial . METHODS : In this prospective triple - blinded randomized controlled trial , we enrolled 86 hospitalized COVID - 19 patients from August to November 2020 , in Shiraz , Iran . The patients were randomly allocated into two groups to receive either methylprednisolone ( 2 mg / kg / day ; intervention group ) or dexamethasone ( 6 mg / day ; control group ) . Data were assessed based on a 9 - point WHO ordinal scale extending from uninfected ( point 0 ) to death ( point 8 ) .
|
{
"P": [
"hospitalized COVID - 19 patients",
"86 hospitalized COVID - 19 patients from August to November 2020 , in Shiraz , Iran"
],
"I": [
"Methylprednisolone",
"methylprednisolone"
],
"C": [
"dexamethasone"
],
"O": [
"a 9 - point WHO ordinal scale"
]
}
|
Title : [ Post - COVID - 19 asthenic syndrome ] . METHODS : The study included 129 patients with an average age of 49 . 88 . 9 years who had undergone COVID - 19 using a continuous sample method . Patients for the study were selected at the clinical bases of outpatient clinics in Samara ( Russia ) in July - August 2020 . All patients signed an informed consent form prior to enrollment . Patients were randomized into two groups : in the main group ( n=64 ) , ethylmethylhydroxypyridine succinate ( Neurox ) was prescribed 1 tablet ( 125 mg ) 3 times a day for 4 weeks ; in the comparison group ( n=65 ) , medical drugs ( MD ) did not contain substances from the pharmacological group related to antihypoxants / antioxidants / nootropics . Three visits ( V ) were conducted : the first ( V1 ) - the period of inclusion , the second ( V2 ) - after 14 days , the third ( V3 ) - on the 28 th day from the start of therapy . The dynamics of the general state ( weakness , fatigue , concentration , dizziness , headache , sleep disorders ) were evaluated on a visual - analog scale ( VAS ) , the assessment of the subjective feeling of severity of asthenia ( fatigue , physical and mental fatigue , decreased motivation and activity ) - on Multidimensional Fatigue Inventory ( MFI - 20 ) , cognitive functions - on Mini - Mental State Examination ( MMSE ) , vegetative tone - according to the Kerdo index .
|
{
"P": [
"129 patients with an average age of 49 . 88 . 9 years who had undergone COVID - 19 using a continuous sample method"
],
"I": [
"ethylmethylhydroxypyridine succinate",
"Neurox"
],
"C": [
"medical drugs ( MD )"
],
"O": [
"The dynamics of the general state",
"weakness",
"fatigue",
"concentration",
"dizziness",
"headache",
"sleep disorders",
"a visual - analog scale ( VAS )",
"the assessment of the subjective feeling of severity of asthenia",
"physical",
"mental fatigue",
"decreased motivation",
"activity",
"Multidimensional Fatigue Inventory ( MFI - 20 )",
"cognitive functions",
"Mini - Mental State Examination ( MMSE )",
"vegetative tone",
"the Kerdo index"
]
}
|
Title : Repurposed Antiviral Drugs for Covid - 19 - Interim WHO Solidarity Trial Results . METHODS : We randomly assigned inpatients with Covid - 19 equally between one of the trial drug regimens that was locally available and open control ( up to five options , four active and the local standard of care ) . The intention - to - treat primary analyses examined in - hospital mortality in the four pairwise comparisons of each trial drug and its control ( drug available but patient assigned to the same care without that drug ) . Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry .
|
{
"P": [
"inpatients with Covid - 19"
],
"I": [
"four active"
],
"C": [
"the local standard of care"
],
"O": [
"in - hospital mortality",
"Rate ratios for death"
]
}
|
Title : Effect of Oral Azithromycin vs Placebo on COVID - 19 Symptoms in Outpatients With SARS - CoV - 2 Infection : A Randomized Clinical Trial . METHODS : Randomized clinical trial of azithromycin vs matching placebo conducted from May 2020 through March 2021 . Outpatients from the US were enrolled remotely via internet - based surveys and followed up for 21 days . Eligible participants had a positive SARS - CoV - 2 diagnostic test result ( nucleic acid amplification or antigen ) within 7 days prior to enrollment , were aged 18 years or older , and were not hospitalized at the time of enrollment . Among 604 individuals screened , 297 were ineligible , 44 refused participation , and 263 were enrolled . Participants , investigators , and study staff were masked to treatment randomization . Participants were randomized in a 2 : 1 fashion to a single oral 1 . 2 - g dose of azithromycin ( n = 171 ) or matching placebo ( n = 92 ) . The primary outcome was absence of self - reported COVID - 19 symptoms at day 14 . There were 23 secondary clinical end points , including all - cause hospitalization at day 21 .
|
{
"P": [
"Outpatients With SARS - CoV - 2 Infection",
"Outpatients from the US"
],
"I": [
"Oral Azithromycin",
"azithromycin",
"a single oral 1 . 2 - g dose of azithromycin"
],
"C": [
"Placebo",
"matching placebo"
],
"O": [
"absence of self - reported COVID - 19 symptoms",
"all - cause hospitalization"
]
}
|
Title : Exploring an Integrative Therapy for Treating COVID - 19 : A Randomized Controlled Trial . METHODS : A putative ARDS - suppressing drug Keguan - 1 was first developed and then evaluated by a randomized , controlled two - arm trial . The two arms of the trial consist of a control therapy ( alpha interferon inhalation , 50 g twice daily ; and lopinavir / ritonavir , 400 and 100 mg twice daily , respectively ) and a testing therapy ( control therapy plus Keguan - 1 19 . 4 g twice daily ) by random number table at 1 : 1 ratio with 24 cases each group . After 2 - week treatment , adverse events , time to fever resolution , ARDS development , and lung injury on newly diagnosed COVID - 19 patients were assessed .
|
{
"P": [
"newly diagnosed COVID - 19 patients"
],
"I": [
"A putative ARDS - suppressing drug Keguan - 1",
"Keguan - 1"
],
"C": [
"alpha interferon inhalation",
"lopinavir",
"ritonavir"
],
"O": [
"adverse events",
"time to fever resolution",
"ARDS development",
"lung injury"
]
}
|
Title : Intravenous high - dose vitamin C for the treatment of severe COVID - 19 : study protocol for a multicentre randomised controlled trial . METHODS : The investigators designed a multicentre prospective randomised placebo - controlled trial that is planned to recruit 308 adults diagnosed with COVID - 19 and transferred into the intensive care unit . Participants will randomly receive HIVC diluted in sterile water or placebo for 7 days once enrolled . Patients with a history of VC allergy , end - stage pulmonary disease , advanced malignancy or glucose - 6 - phosphate dehydrogenase deficiency will be excluded . The primary outcome is ventilation - free days within 28 observational days . This is one of the first clinical trials applying HIVC to treat COVID - 19 , and it will provide credible efficacy and safety data . We predict that HIVC could suppress cytokine storms caused by COVID - 19 , help improve pulmonary function and reduce the risk of ARDS of COVID - 19 .
|
{
"P": [
"308 adults diagnosed with COVID - 19 and transferred into the intensive care unit"
],
"I": [
"Intravenous high - dose vitamin C",
"HIVC"
],
"C": [
"placebo"
],
"O": [
"ventilation - free days"
]
}
|
Title : Lopinavir - ritonavir in patients admitted to hospital with COVID - 19 ( RECOVERY ) : a randomised , controlled , open - label , platform trial . METHODS : In this randomised , controlled , open - label , platform trial , a range of possible treatments was compared with usual care in patients admitted to hospital with COVID - 19 . The trial is underway at 176 hospitals in the UK . Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus lopinavir - ritonavir ( 400 mg and 100 mg , respectively ) by mouth for 10 days or until discharge ( or one of the other RECOVERY treatment groups : hydroxychloroquine , dexamethasone , or azithromycin ) using web - based simple ( unstratified ) randomisation with allocation concealment . Randomisation to usual care was twice that of any of the active treatment groups ( eg , 2 : 1 in favour of usual care if the patient was eligible for only one active group , 2:1:1 if the patient was eligible for two active groups ) . The primary outcome was 28 - day all - cause mortality . Analyses were done on an intention - to - treat basis in all randomly assigned participants . The trial is registered with ISRCTN , 50189673 , and ClinicalTrials . gov , NCT04381936 .
|
{
"P": [
"patients admitted to hospital with COVID - 19"
],
"I": [
"Lopinavir",
"ritonavir",
"usual standard of care",
"lopinavir",
"hydroxychloroquine",
"dexamethasone",
"azithromycin"
],
"C": [
"usual care",
"usual standard of care alone"
],
"O": [
"28 - day all - cause mortality"
]
}
|
Title : Evaluating the effects of Intravenous Immunoglobulin ( IVIg ) on the management of severe COVID - 19 cases : A randomized controlled trial . METHODS : In this randomized controlled trial , 84 patients were included : 52 in the IVIg group and 32 in the control group . The intervention group received IVIg at a dose of 400 mg / kg , IV , daily for three days . Both groups received hydroxychloroquine , lopinavir / ritonavir and supportive care . The demographic data , mortality rate , the need for mechanical ventilation , length of stay in hospital and in Intensive Care Unit ( ICU ) , and imaging findings were recorded and compared in terms of the mentioned factors .
|
{
"P": [
"84 patients"
],
"I": [
"Intravenous Immunoglobulin ( IVIg )",
"the IVIg",
"IVIg",
"hydroxychloroquine",
"lopinavir",
"ritonavir",
"supportive care"
],
"C": [],
"O": [
"The demographic data",
"mortality rate",
"the need for mechanical ventilation",
"length of stay in hospital",
"in Intensive Care Unit ( ICU )",
"imaging findings"
]
}
|
Title : Effect of Ammonium Chloride in addition to standard of care in outpatients and hospitalized COVID - 19 patients : A randomized clinical trial . METHODS : In this double - blind , single - center study , we enrolled patients with positive PCR test and / or CT findings for COVID - 19 . The participants of each group were randomly assigned to Diphenhydramine Compound ( Diphenhydramine + Ammonium Chloride ) plus standard of care or to Diphenhydramine alone and standard of care groups . The primary outcome was all - cause mortality within 30 days of randomization . Secondary outcomes include viral burden , clinical status , assessed by a 5 - point ordinal scale , and length of stay in hospitalized patients .
|
{
"P": [
"outpatients and hospitalized COVID - 19 patients",
"patients with positive PCR test and / or CT findings for COVID - 19"
],
"I": [
"Ammonium Chloride",
"standard of care",
"Diphenhydramine Compound",
"Diphenhydramine"
],
"C": [
"Diphenhydramine alone",
"standard of care"
],
"O": [
"all - cause mortality",
"viral burden",
"clinical status",
"a 5 - point ordinal scale",
"length of stay"
]
}
|
Title : [ A pilot study of hydroxychloroquine in treatment of patients with moderate COVID - 19 ] . METHODS : We prospectively enrolled 30 treatment - nave patients with confirmed COVID - 19 after informed consent at Shanghai Public Health Clinical Center . The patients were randomized 1?1 to HCQ group and the control group . Patients in HCQ group were given HCQ 400 mg per day for 5 days plus conventional treatments , while those in the control group were given conventional treatment only . The primary endpoint was negative conversion rate of SARS - CoV - 2 nucleic acid in respiratory pharyngeal swab on days 7 after randomization . This study has been approved by the Ethics Committee of Shanghai Public Health Clinical Center and registered online ( NCT04261517 ) .
|
{
"P": [
"patients with moderate COVID - 19",
"30 treatment - nave patients with confirmed COVID - 19 after informed consent at Shanghai Public Health Clinical Center"
],
"I": [
"hydroxychloroquine",
"HCQ",
"conventional treatments"
],
"C": [
"conventional treatment only"
],
"O": [
"negative conversion rate of SARS - CoV - 2 nucleic acid in respiratory pharyngeal swab"
]
}
|
Title : Tofacitinib in Patients Hospitalized with Covid - 19 Pneumonia . METHODS : We randomly assigned , in a 1 : 1 ratio , hospitalized adults with Covid - 19 pneumonia to receive either tofacitinib at a dose of 10 mg or placebo twice daily for up to 14 days or until hospital discharge . The primary outcome was the occurrence of death or respiratory failure through day 28 as assessed with the use of an eight - level ordinal scale ( with scores ranging from 1 to 8 and higher scores indicating a worse condition ) . All - cause mortality and safety were also assessed .
|
{
"P": [
"Patients Hospitalized with Covid - 19 Pneumonia",
"hospitalized adults with Covid - 19 pneumonia"
],
"I": [
"Tofacitinib",
"tofacitinib"
],
"C": [
"placebo"
],
"O": [
"the occurrence of death",
"respiratory failure",
"the use of an eight - level ordinal scale",
"All - cause mortality",
"safety"
]
}
|
Title : The Efficacy of Computerized Cognitive Behavioral Therapy for Depressive and Anxiety Symptoms in Patients With COVID - 19 : Randomized Controlled Trial . METHODS : We customized a cCBT program focused on improving depressive and anxiety symptoms among patients with COVID - 19 , and then , we assessed its effectiveness . Screening was based on symptoms of depression or anxiety for patients who scored ?7 on the Hamilton Depression Rating Scale ( HAMD17 ) or the Hamilton Anxiety Scale ( HAMA ) . A total of 252 patients with COVID - 19 at five sites were randomized into two groups : cCBT + treatment as usual ( TAU ; n=126 ) and TAU without cCBT ( n=126 ) . The cCBT + TAU group received the cCBT intervention program for 1 week . The primary efficacy measures were the HAMD17 and HAMA scores . The secondary outcome measures were the Self - Rating Depression Scale ( SDS ) , Self - Rating Anxiety Scale ( SAS ) , and Athens Insomnia Scale ( AIS ) . Assessments were carried out pre - and postintervention . The patients ' symptoms of anxiety and depression in one of the centers were assessed again within 1 month after the postintervention assessment .
|
{
"P": [
"Patients With COVID - 19",
"patients with COVID - 19",
"A total of 252 patients with COVID - 19 at five sites"
],
"I": [
"Computerized Cognitive Behavioral Therapy",
"a cCBT program",
"cCBT",
"treatment as usual ( TAU",
"The cCBT",
"TAU",
"the cCBT intervention program"
],
"C": [
"TAU",
"cCBT"
],
"O": [
"the HAMD17",
"HAMA scores",
"the Self - Rating Depression Scale ( SDS )",
"Self - Rating Anxiety Scale ( SAS )",
"Athens Insomnia Scale ( AIS )",
"The patients ' symptoms of anxiety",
"depression"
]
}
|
Title : A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid - 19 . METHODS : In this platform trial of therapeutic agents , we randomly assigned hospitalized patients who had Covid - 19 without end - organ failure in a 1 : 1 ratio to receive either LY - CoV555 or matching placebo . In addition , all the patients received high - quality supportive care as background therapy , including the antiviral drug remdesivir and , when indicated , supplemental oxygen and glucocorticoids . LY - CoV555 ( at a dose of 7000 mg ) or placebo was administered as a single intravenous infusion over a 1 - hour period . The primary outcome was a sustained recovery during a 90 - day period , as assessed in a time - to - event analysis . An interim futility assessment was performed on the basis of a seven - category ordinal scale for pulmonary function on day 5 .
|
{
"P": [
"Hospitalized Patients with Covid - 19",
"hospitalized patients who had Covid - 19 without end - organ failure"
],
"I": [
"LY - CoV555",
"the antiviral drug remdesivir",
"supplemental oxygen",
"glucocorticoids"
],
"C": [
"matching placebo",
"placebo"
],
"O": [
"a sustained recovery",
"seven - category ordinal scale for pulmonary function"
]
}
|
Title : The effects of narrative exposure therapy on COVID - 19 patients with post - traumatic stress symptoms : A randomized controlled trial . METHODS : A total of 111 COVID - 19 patients near the discharge stage with positive screening results for posttraumatic stress symptoms ( PTSS ) were randomly assigned ( 1 : 1 ) to either the study group or the control group . The study group received NET and personalized psychological intervention , while the control group only received personalized psychological intervention . PTSS , depression , anxiety and sleep quality were measured pre - and post - intervention to evaluate the effect of NET . This trial was registered with the International Standard Randomized Clinical Trial Registry ( No . ChiCTR2000039369 ) .
|
{
"P": [
"COVID - 19 patients with post - traumatic stress symptoms",
"A total of 111 COVID - 19 patients near the discharge stage with positive screening results for posttraumatic stress symptoms ( PTSS )"
],
"I": [
"narrative exposure therapy",
"NET",
"personalized psychological intervention"
],
"C": [
"personalized psychological intervention"
],
"O": [
"PTSS",
"depression",
"anxiety",
"sleep quality"
]
}
|
Title : Effect of Intermediate - Dose vs Standard - Dose Prophylactic Anticoagulation on Thrombotic Events , Extracorporeal Membrane Oxygenation Treatment , or Mortality Among Patients With COVID - 19 Admitted to the Intensive Care Unit : The INSPIRATION Randomized Clinical Trial . METHODS : Multicenter randomized trial with a 2 2 factorial design performed in 10 academic centers in Iran comparing intermediate - dose vs standard - dose prophylactic anticoagulation ( first hypothesis ) and statin therapy vs matching placebo ( second hypothesis ; not reported in this article ) among adult patients admitted to the ICU with COVID - 19 . Patients were recruited between July 29 , 2020 , and November 19 , 2020 . The final follow - up date for the 30 - day primary outcome was December 19 , 2020 . Intermediate - dose ( enoxaparin , 1 mg / kg daily ) ( n = 276 ) vs standard prophylactic anticoagulation ( enoxaparin , 40 mg daily ) ( n = 286 ) , with modification according to body weight and creatinine clearance . The assigned treatments were planned to be continued until completion of 30 - day follow - up . The primary efficacy outcome was a composite of venous or arterial thrombosis , treatment with extracorporeal membrane oxygenation , or mortality within 30 days , assessed in randomized patients who met the eligibility criteria and received at least 1 dose of the assigned treatment . Prespecified safety outcomes included major bleeding according to the Bleeding Academic Research Consortium ( type 3 or 5 definition ) , powered for noninferiority ( a noninferiority margin of 1 . 8 based on odds ratio ) , and severe thrombocytopenia ( platelet count < 20 103 / L ) . All outcomes were blindly adjudicated .
|
{
"P": [
"Patients With COVID - 19 Admitted to the Intensive Care Unit",
"adult patients admitted to the ICU with COVID - 19"
],
"I": [
"Intermediate - Dose",
"intermediate - dose",
"statin therapy",
"Intermediate - dose ( enoxaparin"
],
"C": [
"Standard - Dose Prophylactic Anticoagulation",
"standard - dose prophylactic anticoagulation",
"matching placebo",
"standard prophylactic anticoagulation ( enoxaparin"
],
"O": [
"a composite of venous",
"arterial thrombosis",
"treatment with extracorporeal membrane oxygenation",
"mortality",
"major bleeding",
"the Bleeding Academic Research Consortium ( type 3 or 5 definition )",
"powered for noninferiority",
"severe thrombocytopenia"
]
}
|
Title : Remdesivir for the Treatment of Covid - 19 - Final Report . METHODS : We conducted a double - blind , randomized , placebo - controlled trial of intravenous remdesivir in adults who were hospitalized with Covid - 19 and had evidence of lower respiratory tract infection . Patients were randomly assigned to receive either remdesivir ( 200 mg loading dose on day 1 , followed by 100 mg daily for up to 9 additional days ) or placebo for up to 10 days . The primary outcome was the time to recovery , defined by either discharge from the hospital or hospitalization for infection - control purposes only .
|
{
"P": [
"adults who were hospitalized with Covid - 19 and had evidence of lower respiratory tract infection"
],
"I": [
"Remdesivir",
"intravenous remdesivir",
"remdesivir"
],
"C": [
"placebo"
],
"O": [
"the time to recovery",
"discharge from the hospital",
"hospitalization for infection - control purposes only"
]
}
|
Title : Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment ( PROTECT ) of Hydroxychloroquine , Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID - 19 infection who have no comorbidities like diabetes mellitus : A structured summary of a study protocol for a randomized controlled trial . METHODS : An adaptive design , set within a comprehensive cohort study , to permit flexibility in this fast - changing clinical and public health scenario . The randomized study will be a multicenter , multiarm , multistage , randomized controlled trial with a parallel design . An observation only cohort will emerge from those not consenting to randomization . Eligible will be newly diagnosed patients , either hospitalized or in self - isolation , without any comorbidities or with controlled chronic medical conditions like diabetes mellitus and hypertension . Participants of any gender or age group having tested positive for COVID - 19 on Real - Time qRT - PCR ( Quantitative Reverse Transcription PCR ) will be invited to take part in study at twelve centers across eight cities in Pakistan . Those pregnant or lactating , severely dyspneic or with respiratory distress , already undergoing treatment , and with serious comorbidities like liver or kidney failure will be excluded . METHODS : Participants will be randomized , maintaining concealment of allocation sequence , using a computer - generated random number list of variable block size into multiple intervention groups in the allocation ratio of 1 : 1 for all groups . This is an open label study , neither physician nor participants will be blinded . This is an adaptive design and parameters for formal sample size calculation in a new disease of a previously unknown virus are not available . Thus , the final sample size will be subjected to periodic reviews at each stage of adaptive design and subsequent advice of National Data Safety & Management Board ( NDSMB ) notified by Drug Regulatory Authority of Pakistan . Protocol Version 1 . 7 dated July 5 , 2020 . By July 03 , 2020 , the trial had recruited a total of about 470 participants across 12 centers after approval from the National Bioethics Committee and Drug Regulatory Authority of Pakistan . Recruitment started on April 20 , 2020 . The recruitment is expected to continue for at least three months subject to review by the National Data Safety and Management Board ( NDSMB ) notified by Drug Regulatory Authority of Pakistan .
|
{
"P": [
"newly diagnosed patients with COVID - 19 infection who have no comorbidities like diabetes mellitus",
"newly diagnosed patients , either hospitalized or in self - isolation , without any comorbidities or with controlled chronic medical conditions like diabetes mellitus and hypertension"
],
"I": [
"Hydroxychloroquine",
"Oseltamivir",
"Azithromycin"
],
"C": [],
"O": []
}
|
Title : Clinical , Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID - 19 . METHODS : This clinical trial included 114 patients diagnosed as mild COVID - 19 . Patients were divided randomly into two age and sex - matched groups ; group A comprising 57 patients received ivermectin nanosuspension nasal spray twice daily plus the Egyptian protocol of treatment for mild COVID - 19 and group B comprising 57 patients received the Egyptian protocol for mild COVID - 19 only . Evaluation of the patients was performed depending on improvement of presenting manifestations , negativity of two consecutive pharyngeal swabs for the COVID - 19 nucleic acid via rRT - PCR and assessments of hematological and biochemical parameters in the form of complete blood counts , C - reactive protein , serum ferritin and d - dimer which were performed at presentation and 7 days later .
|
{
"P": [
"114 patients diagnosed as mild COVID - 19"
],
"I": [
"Ivermectin Mucoadhesive Nanosuspension Nasal Spray",
"ivermectin nanosuspension nasal spray",
"the Egyptian protocol of treatment for mild COVID - 19"
],
"C": [
"the Egyptian protocol for mild COVID - 19 only"
],
"O": [
"improvement of presenting manifestations",
"negativity of two consecutive pharyngeal swabs for the COVID - 19 nucleic acid",
"rRT - PCR",
"hematological",
"biochemical parameters in the form of complete blood counts",
"C - reactive protein",
"serum ferritin",
"d - dimer"
]
}
|
Title : Efficacy of two siddha polyherbal decoctions , Nilavembu Kudineer and Kaba Sura Kudineer , along with standard allopathy treatment in the management of mild to moderate symptomatic COVID - 19 patients - a double - blind , placebo - controlled , clinical trial . METHODS : The study was a double - blind , placebo - controlled comparative clinical trial , with the primary objective of determining the efficacy of KSK and NVK . Patients ( n=125 ) diagnosed with mild to moderate COVID - 19 symptoms were enrolled in the study over a period of 4 months ( Aug 2020 - Dec 2020 ) . Participants were randomized into 3 arms ; placebo - decaffeinated tea in Arm I , NVK in Arm II , and KSK in Arm III . Each arm received 60 ml of the respective treatment twice a day , post morning and evening meals , along with standard allopathy treatment for a maximum of 10 days . The main outcome measures of the study were the reduction in SARS - CoV - 2 viral load , hospital stay , and time taken by the patients to become asymptomatic from symptomatic . Efficacy assessments included clinical symptoms ( fever , cough , and breathlessness ) each day and real - time reverse transcription - polymerase chain reaction ( RT - PCR ) , liver function test ( LFT ) , renal function test ( RFT ) , and electrolytes and electrocardiogram ( ECG ) at baseline ( day 0 ) and days 3 , 6 , and 10 . Post - treatment , participants were followed up for 30 days via phone for adverse effects if any . Effects of drugs on inflammatory markers ( IL6 ) at the end of treatment were also recorded . Adverse events ( AE ) were monitored throughout the study .
|
{
"P": [
"mild to moderate symptomatic COVID - 19 patients",
"Patients ( n=125 ) diagnosed with mild to moderate COVID - 19 symptoms"
],
"I": [
"two siddha polyherbal decoctions",
"Nilavembu Kudineer",
"Kaba Sura Kudineer",
"standard allopathy treatment",
"KSK",
"NVK"
],
"C": [
"placebo",
"decaffeinated tea"
],
"O": [
"SARS - CoV - 2 viral load",
"hospital stay",
"time taken by the patients to become asymptomatic from symptomatic",
"clinical symptoms",
"fever",
"cough",
"breathlessness",
"real - time reverse transcription - polymerase chain reaction ( RT - PCR )",
"liver function test ( LFT )",
"renal function test ( RFT )",
"electrolytes and electrocardiogram ( ECG )",
"inflammatory markers",
"IL6",
"Adverse events ( AE )"
]
}
|
Title : Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID - 19 : A Randomized Clinical Trial . METHODS : Randomized , open - label trial of hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 ( SARS - CoV - 2 ) infection and moderate COVID - 19 pneumonia ( pulmonary infiltrates and room - air oxygen saturation > 94 % ) enrolled from March 15 through April 18 , 2020 , at 105 hospitals in the United States , Europe , and Asia . The date of final follow - up was May 20 , 2020 . Patients were randomized in a 1:1:1 ratio to receive a 10 - day course of remdesivir ( n = 197 ) , a 5 - day course of remdesivir ( n = 199 ) , or standard care ( n = 200 ) . Remdesivir was dosed intravenously at 200 mg on day 1 followed by 100 mg / d . The primary end point was clinical status on day 11 on a 7 - point ordinal scale ranging from death ( category 1 ) to discharged ( category 7 ) . Differences between remdesivir treatment groups and standard care were calculated using proportional odds models and expressed as odds ratios . An odds ratio greater than 1 indicates difference in clinical status distribution toward category 7 for the remdesivir group vs the standard care group .
|
{
"P": [
"Patients With Moderate COVID - 19",
"hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 ( SARS - CoV - 2 ) infection and moderate COVID - 19 pneumonia ( pulmonary infiltrates and room - air oxygen saturation > 94 % ) enrolled from March 15 through April 18 , 2020 , at 105 hospitals in the United States , Europe , and Asia"
],
"I": [
"Remdesivir",
"a 10 - day course of remdesivir",
"a 5 - day course of remdesivir",
"remdesivir treatment",
"the remdesivir"
],
"C": [
"Standard Care",
"standard care",
"the standard care"
],
"O": [
"clinical status",
"a 7 - point ordinal scale"
]
}
|
Title : Azithromycin in patients admitted to hospital with COVID - 19 ( RECOVERY ) : a randomised , controlled , open - label , platform trial . METHODS : In this randomised , controlled , open - label , adaptive platform trial ( Randomised Evaluation of COVID - 19 Therapy [ RECOVERY ] ) , several possible treatments were compared with usual care in patients admitted to hospital with COVID - 19 in the UK . The trial is underway at 176 hospitals in the UK . Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once per day by mouth or intravenously for 10 days or until discharge ( or allocation to one of the other RECOVERY treatment groups ) . Patients were assigned via web - based simple ( unstratified ) randomisation with allocation concealment and were twice as likely to be randomly assigned to usual care than to any of the active treatment groups . Participants and local study staff were not masked to the allocated treatment , but all others involved in the trial were masked to the outcome data during the trial . The primary outcome was 28 - day all - cause mortality , assessed in the intention - to - treat population . The trial is registered with ISRCTN , 50189673 , and ClinicalTrials . gov , NCT04381936 .
|
{
"P": [
"patients admitted to hospital with COVID - 19",
"patients admitted to hospital with COVID - 19 in the UK"
],
"I": [
"Azithromycin",
"usual standard of care",
"azithromycin"
],
"C": [
"usual standard of care alone"
],
"O": [
"28 - day all - cause mortality"
]
}
|
Title : Dexamethasone in Hospitalized Patients with Covid - 19 . METHODS : In this controlled , open - label trial comparing a range of possible treatments in patients who were hospitalized with Covid - 19 , we randomly assigned patients to receive oral or intravenous dexamethasone ( at a dose of 6 mg once daily ) for up to 10 days or to receive usual care alone . The primary outcome was 28 - day mortality . Here , we report the final results of this assessment .
|
{
"P": [
"Hospitalized Patients with Covid - 19",
"patients who were hospitalized with Covid - 19"
],
"I": [
"Dexamethasone",
"oral",
"intravenous dexamethasone"
],
"C": [
"usual care alone"
],
"O": [
"28 - day mortality"
]
}
|
Title : Telemanagement of Home - Isolated COVID - 19 Patients Using Oxygen Therapy With Noninvasive Positive Pressure Ventilation and Physical Therapy Techniques : Randomized Clinical Trial . METHODS : In this single - blinded randomized clinical trial , 60 patients with stage 1 pneumonia caused by SARS - CoV - 2 infection were treated . Group A ( n=30 ) received oxygen therapy with bilevel positive airway pressure ( BiPAP ) ventilation , and Group B ( n=30 ) received osteopathic manipulative respiratory and physical therapy techniques . Arterial blood gases of PaO2 and PaCO2 , pH , vital signs ( ie , temperature , respiratory rate , oxygen saturation , heart rate , and blood pressure ) , and chest computed tomography scans were used for follow - up and for assessment of the course and duration of recovery .
|
{
"P": [
"Home - Isolated COVID - 19 Patients",
"60 patients with stage 1 pneumonia caused by SARS - CoV - 2 infection"
],
"I": [
"Oxygen Therapy",
"Noninvasive Positive Pressure Ventilation",
"Physical Therapy Techniques",
"oxygen therapy",
"bilevel positive airway pressure ( BiPAP ) ventilation",
"osteopathic manipulative respiratory",
"physical therapy techniques"
],
"C": [],
"O": [
"Arterial blood gases of PaO2",
"PaCO2",
"pH",
"vital signs",
"temperature",
"respiratory rate",
"oxygen saturation",
"heart rate",
"blood pressure",
"chest computed tomography scans",
"the course",
"duration of recovery"
]
}
|
Title : Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID - 19 : A Randomized Clinical Trial . METHODS : Double - blind , randomized trial conducted at a single site in Cali , Colombia . Potential study participants were identified by simple random sampling from the state ' s health department electronic database of patients with symptomatic , laboratory - confirmed COVID - 19 during the study period . A total of 476 adult patients with mild disease and symptoms for 7 days or fewer ( at home or hospitalized ) were enrolled between July 15 and November 30 , 2020 , and followed up through December 21 , 2020 . Patients were randomized to receive ivermectin , 300 ?g / kg of body weight per day for 5 days ( n = 200 ) or placebo ( n = 200 ) . Primary outcome was time to resolution of symptoms within a 21 - day follow - up period . Solicited adverse events and serious adverse events were also collected .
|
{
"P": [
"Adults With Mild COVID - 19",
"A total of 476 adult patients with mild disease and symptoms for 7 days or fewer ( at home or hospitalized )"
],
"I": [
"Ivermectin",
"ivermectin"
],
"C": [
"placebo"
],
"O": [
"time to resolution of symptoms",
"Solicited adverse events",
"serious adverse events"
]
}
|
Title : The value of high - flow nasal cannula oxygen therapy in treating novel coronavirus pneumonia . METHODS : The clinical data of 22 patients with severe COVID - 19 were collected . The heart rate ( HR ) , respiratory rate ( RR ) and oxygenation index ( PO2 / FiO2 ) at 0 , 6 , 24 and 72 hours after treatment were compared between the HFNC oxygen therapy group and the conventional oxygen therapy ( COT ) group . In addition , the white blood cell ( WBC ) count , lymphocyte ( L ) count , C - reactive protein ( CRP ) and procalcitonin ( PCT ) were compared before and at 72 hours after oxygen therapy treatment .
|
{
"P": [
"22 patients with severe COVID - 19"
],
"I": [
"high - flow nasal cannula oxygen therapy",
"the HFNC oxygen therapy"
],
"C": [
"the conventional oxygen therapy ( COT )"
],
"O": [
"The heart rate ( HR )",
"respiratory rate ( RR )",
"oxygenation index",
"PO2",
"FiO2",
"the white blood cell ( WBC ) count",
"lymphocyte ( L ) count",
"C - reactive protein ( CRP )",
"procalcitonin ( PCT )"
]
}
|
Title : Convalescent plasma in the management of moderate covid - 19 in adults in India : open label phase II multicentre randomised controlled trial ( PLACID Trial ) . METHODS : Open label , parallel arm , phase II , multicentre , randomised controlled trial . 39 public and private hospitals across India . 464 adults ( ?18 years ) admitted to hospital ( screened 22 April to 14 July 2020 ) with confirmed moderate covid - 19 ( partial pressure of oxygen in arterial blood / fraction of inspired oxygen ( PaO2 / FiO2 ) ratio between 200 mm Hg and 300 mm Hg or a respiratory rate of more than 24 / min with oxygen saturation 93 % or less on room air ) : 235 were assigned to convalescent plasma with best standard of care ( intervention arm ) and 229 to best standard of care only ( control arm ) . Participants in the intervention arm received two doses of 200 mL convalescent plasma , transfused 24 hours apart . The presence and levels of neutralising antibodies were not measured a priori ; stored samples were assayed at the end of the study . Composite of progression to severe disease ( PaO2 / FiO2 < 100 mm Hg ) or all cause mortality at 28 days post - enrolment .
|
{
"P": [
"adults in India",
"464 adults ( ?18 years ) admitted to hospital ( screened 22 April to 14 July 2020 ) with confirmed moderate covid - 19 ( partial pressure of oxygen in arterial blood / fraction of inspired oxygen ( PaO2 / FiO2 ) ratio between 200 mm Hg and 300 mm Hg or a respiratory rate of more than 24 / min with oxygen saturation 93 % or less on room air )"
],
"I": [
"Convalescent plasma",
"convalescent plasma with best standard of care",
"with best standard of care",
"two doses of 200 mL convalescent plasma"
],
"C": [
"best standard of care only"
],
"O": [
"Composite of progression to severe disease",
"PaO2",
"FiO2",
"all cause mortality"
]
}
|
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