title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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References | PMC10258964 | |||
Background | CYTOTOXICITY, HER2+ BREAST CANCER | The phase II neo-adjuvant clinical trial ICORG10-05 (NCT01485926) compared chemotherapy in combination with trastuzumab, lapatinib or both in patients with HER2+ breast cancer. We studied circulating immune cells looking for alterations in phenotype, genotype and cytotoxic capacity (direct and antibody-dependent cell-m... | PMC10491671 | |
Methods | Peripheral blood mononuclear cells (PBMCs) were isolated from pre- ( | PMC10491671 | ||
Results | ER+ tumours | RESIDUAL DISEASE | Treatment attenuated the cytotoxicity/ADCC of PBMCs. CD3+/CD4+/CD8+ T cells increased following therapy, while CD56+ NK cells/CD14+ monocytes/CD19+ B cells decreased with significant post-treatment immune cell changes confined to patients with residual disease. Pembrolizumab-augmented ex vivo PBMC ADCC activity was ass... | PMC10491671 |
Conclusions | PBMCs display altered phenotype and function following completion of neo-adjuvant treatment. Anti-PD-1-responsive PBMCs in ex vivo ADCC assays may be a biomarker of treatment response. | PMC10491671 | ||
Subject terms | PMC10491671 | |||
Introduction | breast cancers, breast cancer | CYTOTOXICITY, HER2+ BREAST CANCER, BREAST CANCER | Human epidermal growth factor receptor 2-positive (HER2+) breast cancer accounts for approximately 20% of all breast cancers [Trastuzumab was the first HER2-targeted therapy approved for the treatment of HER2+ breast cancer. Trastuzumab targets a juxtamembrane epitope in subdomain IV of the extracellular portion of the... | PMC10491671 |
Materials and methods | PMC10491671 | |||
Cell lines and reagents | Cell lines were cultured at 37 °C/5% CO | PMC10491671 | ||
Patient population and sampling time points | HER2+ BREAST CANCER | HER2+ breast cancer patients ( | PMC10491671 | |
Sample processing | BLOOD | Blood was collected in EDTA blood tubes (BD Vacutainer #367525) and processed within 4 h of blood draw. PBMCs were isolated using Ficoll-Paque (ThermoFisher 11778538)-based density centrifugation. PBMCs were frozen in vials at 1 × 10 | PMC10491671 | |
Immune cytotoxicity assays | ALDRICH, CYTOTOXICITY | The immune cytotoxicity assays described are based on flow cytometry-based protocols utilised previously, involving carboxyfluorescein succinimidyl ester (CFSE) (Sigma Aldrich 21888) staining of target cells and the use of aminoactinomycin-D (7AAD) (Sigma Aldrich 9400) as the membrane permeable dead cell dye [ | PMC10491671 | |
Fc gamma receptor genotyping | Patient samples ( | PMC10491671 | ||
Peripheral blood immunophenotyping | Healthy volunteer and patient PBMCs were isolated, thawed and counted as previously described. PBMC samples were brought to a concentration of 3 × 10 | PMC10491671 | ||
Tumour infiltrating lymphocytes | tumour | TUMOUR, INFILTRATING | Pre-treatment and on-treatment (20 days post cycle 1) stromal, tumour and overall (stromal + tumour) infiltrating lymphocyte counts for ICORG 10-05 were determined previously [ | PMC10491671 |
Ethical approval | ONCOLOGY | The ICORG 10-05 clinical trial was conducted in accordance with the Declaration of Helsinki. The trial was approved by the relevant ethics committees/institutional review boards and health authorities at all participating sites in Ireland under the direction of the study sponsor, the All-Ireland Clinical Oncology Resea... | PMC10491671 | |
Statistical analysis | A pooled Student’s | PMC10491671 | ||
Results | PMC10491671 | |||
Patient characteristics | Eighty-eight patients were enrolled on the TCHL study, comprising of TCH ( | PMC10491671 | ||
Breakdown of available samples. | Consort diagram ( | PMC10491671 | ||
Downregulation of peripheral cytotoxic immune response following completion of neo-adjuvant chemotherapy | CYTOTOXICITY | The cytotoxicity levels of PBMCs pre- and post-treatment were examined in all available samples. An optimal pooled | PMC10491671 | |
Changes to immune cell subsets following neo-adjuvant therapy | CD45+ PBMCs from patients that have completed neo-adjuvant chemotherapy regimens displayed alterations in immunophenotype. The immunophenotype data, and all following data presented in Figs. | PMC10491671 | ||
Pre- and post-treatment immune cell subsets. | Proportion of CD45+ cells staining positive for | PMC10491671 | ||
Direct cytotoxicity and ADCC by pCR status. | CYTOTOXICITY | Paired pre- and post-treatment direct cytotoxicity levels of patient PBMCs against | PMC10491671 | |
Immune cell subsets by pCR status. | tumour | CYTOTOXICITY, TUMOUR | Proportion of CD45+ cells which stained positive for The proportion of CD3+ T cells significantly increased following neo-adjuvant treatment (Fig. Diametric changes were observed in other circulating immune cell populations. There was a significant decrease in the proportion of CD56+ NK cells (Fig. Peripheral T cells a... | PMC10491671 |
Post-treatment cytotoxic immune response did not vary based on pCR and no pCR | CYTOTOXICITY | To ascertain if variances in in vitro PBMC cytotoxicity due to neo-adjuvant treatment could be associated with patient response to therapy, the in vitro cytotoxicity data was broken down by pCR. There was no change in direct cytotoxicity against the K562 or SKBR3 cell lines based on clinical response between pre- and p... | PMC10491671 | |
Post-treatment changes in immune cell subsets are driven by the No pCR cohort | Immunophenotype data was also assessed in the context of pCR. There were no significant differences in the immune cell populations pre- and post-treatment within the pCR cohort (Fig. | PMC10491671 | ||
Baseline circulating immune cells from patients with no pCR have augmented cytotoxic response after treatment with pembrolizumab | Examining PD-1 expression on CD56+, CD8+, and CD14+ subsets reveals that PD-1 expression was present but there was no difference between pre- and post-treatment when divided based on treatment response (Supplementary Fig. | PMC10491671 | ||
Pembrolizumab-responsive PBMCs in the No pCR cohort. | Trastuzumab ADCC levels with and without pembrolizumab against SKBR3 cells using pre-treatment patient PBMCs from In addition, the pre-treatment PD-1 inhibited ADCC response (Fig. | PMC10491671 | ||
TIL levels are lower in patients with in vitro PBMC response to pembrolizumab | Matched pre-treatment TIL data were available for 13/21 pre-treatment PBMC samples utilised in the pembrolizumab ADCC assays [ | PMC10491671 | ||
Treatment arm did not affect immune cytotoxicity or PBMC immunophenotype | CYTOTOXICITY | No significant difference was found when post-treatment direct cytotoxicity (K562/SKBR3) or ADCC (SKBR3) were compared to pre-treatment levels within arms (Supplementary Fig. | PMC10491671 | |
Discussion | non-small cell lung cancer, ER+ tumours, melanoma, breast cancer, tumours, TNBC, immune-suppressed tumour | NON-SMALL CELL LUNG CANCER, MELANOMA, BREAST CANCER, TUMOURS, CYTOTOXICITY, HER2+ BREAST CANCER | We report that neo-adjuvant treatment reduced the direct cytotoxic and ADCC capacity of circulating immune cells for all patients on the ICORG 10-05 trial, irrespective of FCGR SNP status. This corresponded with post-treatment increases in circulating CD8+ and CD4+ T cells, and decreased levels of NK cells, monocytes a... | PMC10491671 |
Supplementary information | The online version contains supplementary material available at 10.1038/s41416-023-02375-y. | PMC10491671 | ||
Acknowledgements | Cancer | ONCOLOGY, CANCER | We wish to thank the patients who participated in the ICORG 10-05 clinical trial and the healthy volunteers who provided blood samples. The clinical trial was sponsored by the All-Ireland Clinical Oncology Research Group (ICORG), now known as Cancer Trials Ireland – CTRIAL-IE, which received funding from GlaxoSmith-Kli... | PMC10491671 |
Author contributions | NG, AB, SFM, ST, and DMC conceived/designed experiments and acquired and interpreted data. DK, AJE, MSJM, and AC acquired and interpreted data. BM, JMF, NOD, and JC conceived/designed experiments and interpreted data. JSR, AT, and BTH interpreted data. All authors partook in manuscript drafting/revision, approved the f... | PMC10491671 | ||
Funding | Cancer | CANCER | This translational study was funded by The Caroline Foundation and the Cancer Clinical Research Trust (CHY12210). Open Access funding provided by the IReL Consortium. | PMC10491671 |
Data availability | The datasets generated during and/or analysed during the current study are not publicly available due to the terms of ethics approval/consent for the study and data privacy regulations but are available from the corresponding author on reasonable request. | PMC10491671 | ||
Competing interests | CMO, cancer | ONCOLOGY, CANCER | JC has received honoraria from Pfizer, MSD Oncology, Pierre Fabre, and AstraZeneca; has acted in a Consulting or Advisory Role for AstraZeneca, Novartis, MSD, Cepheid and received Speakers' Bureau from Pfizer; has received research funding from Boehringer Ingelheim, Roche, Puma Biotechnology Regeneron, Novartis, MSD On... | PMC10491671 |
References | PMC10491671 | |||
Background | Leprosy, leprosy, infectious disease | LEPROSY, LEPROSY, INFECTIOUS DISEASE | Leprosy is an ancient infectious disease with an annual global incidence of around 200,000 over the past decade. Since 2018, the World Health Organization (WHO) recommends single-dose rifampicin as post-exposure prophylaxis (SDR-PEP) for contacts of leprosy patients. The Post ExpOsure Prophylaxis for Leprosy (PEOPLE) t... | PMC10169125 |
Methods | leprosy, tuberculosis | LEPROSY, TUBERCULOSIS | BE-PEOPLE is a cluster-randomized trial in which 44 clusters in Comoros will be randomized to two study arms. Door-to-door screening will be conducted annually during four years, leprosy patients identified will be offered standard of care treatment. Based on study arm, contacts aged five years and above and living wit... | PMC10169125 |
Discussion | leprosy | LEPROSY | The COLEP trial on PEP in Bangladesh documented a reduction of 57% in incidence of leprosy among contacts treated with SDR-PEP after two years, which led to the WHO recommendation of SDR-PEP. Preliminary results of the PEOPLE trial show a lesser reduction in incidence. The BE-PEOPLE trial will explore whether reinforci... | PMC10169125 |
Trial registration | NCT05597280. Protocol version 5.0 on 28 October 2022. | PMC10169125 | ||
Keywords | PMC10169125 | |||
Background | Leprosy, leprosy, infection, chronic infectious disease | LEPROSY, MAY, LEPROSY, INFECTION, CHRONIC INFECTIOUS DISEASE | BE-PEOPLE is a randomized controlled trial assessing the effectiveness of bedaquiline and rifampicin as post-exposure prophylaxis (PEP) for leprosy in Comoros. Leprosy is an ancient chronic infectious disease caused by In 2000, the World Health Organization (WHO) declared leprosy eliminated as public health problem bas... | PMC10169125 |
Methods/design | PMC10169125 | |||
Objectives and hypothesis | leprosy | ADVERSE EVENT, SECONDARY, LEPROSY | The primary objective of BE-PEOPLE will be to compare effectiveness of BE-PEP to that of SDR-PEP at individual level. As a secondary objective, we will compare overall leprosy incidence between villages randomized to BE-PEP and villages randomized to SDR-PEP. Adverse events will be closely monitored and quantified per ... | PMC10169125 |
Study design | TB, Leprosy, leprosy, Mohéli | ADVERSE EVENTS, LEPROSY, LEPROSY | The BE-PEOPLE trial is a cluster randomized trial in which 44 clusters from the islands of Anjouan and Mohéli (Comoros) will be randomized to two study arms. These include 34 out of 48 villages that were also part of the PEOPLE trial as well as nine new villages of which one has been divided into two. For randomization... | PMC10169125 |
Setting | TB, Mohéli, deformities, Leprosy, Tuberculosis, leprosy | TUBERCULOSIS (TB), LEPROSY, LEPROSY, TUBERCULOSIS | The Union of Comoros is an archipelago in the Indian Ocean, north of Madagascar, and includes the islands Grand Comore (with the capital Moroni), Anjouan, and Mohéli. Since 2011, around 400 new leprosy cases are notified annually. The vast majority of these cases come from Anjouan and Mohéli with an estimated populatio... | PMC10169125 |
Participants | cough, liver or kidney disease, leprosy, allergy | LEPROSY, ALLERGY | Participants will be enrolled from 44 clusters: 34 in Anjouan and 10 in Mohéli. We will screen for leprosy including all residents and all ages, whenever leprosy is diagnosed treatment will be provided according to national guidelines. At baseline, all permanent residents aged two years or above, living within 100 m of... | PMC10169125 |
Randomization | The 44 study clusters will be grouped into 10 categories, by island (Anjouan and Mohéli) and in relation to the PEOPLE trial (former arm 1,2,3, or 4, or new). Within each group, they will be ordered by decreasing baseline prevalence and pairs will be constituted of successive clusters. Within each pair, one will be ran... | PMC10169125 | ||
Outcome measures | TB, leprosy | ADVERSE EVENTS, LEPROSY, SECONDARY | The primary outcome will be the leprosy incidence rate ratio between contacts who received SDR-PEP and contacts who received BE-PEP, excluding those in arm 1 who received SDR-PEP because of not being eligible for BE-PEP due to age and/or weight restrictions. In a secondary analysis, we will calculate the incidence rate... | PMC10169125 |
Intervention implementation and data collection | TB, scabies, Mohéli, vomiting, leprosy, loss of sensation, eczema, Vomiting | SCABIES, ADVERSE EVENTS, EVENT, MYCOSES, LEPROSY, SKIN DISEASES, ECZEMA | Before the study begins, village elders will be informed about study objectives and procedures, followed by community sensitization. Annual door-to-door screening for leprosy will be conducted from 2023 to 2026, by teams that consist of experienced health services staff and community volunteers. Data to be collected in... | PMC10169125 |
Post-exposure prophylaxis | PMC10169125 | |||
Single dose rifampicin | leprosy | LEPROSY | A single dose of rifampicin at 10 mg/kg is the current standard for PEP in leprosy for contacts aged two years and above, as per the 2018 WHO guidelines [ | PMC10169125 |
Rationale for using serology | Although detection of | PMC10169125 | ||
Rationale bedaquiline and rifampicin combination | Bedaquiline, the first new drug to be developed against The bioavailability of bedaquiline increases with food (a 2-fold increase in AUC, see label). The exposure of rifampicin, when administered with food, decreases slightly but this is not considered clinically relevant. Therefore, we will offer a snack when PEP is a... | PMC10169125 | ||
Data analysis | TB, leprosy | LEPROSY | To assess the effectiveness of PEP at the individual level, we will fit a Poisson model adjusted for follow-up time as an offset term with the villages nested in islands as a random effect and type of PEP (BE-PEP or SDR-PEP) as an explanatory variable, with SDR-PEP as reference category. We will exclude participants be... | PMC10169125 |
Sample size | For sample size calculations we used the methodology described by Hayes and Bennet for cluster randomized trials [To assess the effect of BE-PEP at the village level, the entire population examined will be considered in the analysis. If incidence at the village level is 1.1 per 1,000 per year, as observed in the PEOPLE... | PMC10169125 | ||
Ethics | The study will be carried out according to the principles stated in the Declaration of Helsinki, Good Clinical Practice (GCP), General Data Protection Regulation (GDPR), and all applicable regulations and according to established international scientific standards. A yearly update on the status of the study will be pro... | PMC10169125 | ||
Acknowledgements | Leprosy, Tuberculosis | LEPROSY, TUBERCULOSIS | We thank the National Tuberculosis and Leprosy Program of the Union of the Comoros Damien Foundation, and the Institute of Tropical Medicine of Antwerp Belgium for their support. | PMC10169125 |
Author Contribution | RS | AY, SNS, BAT, AP, NA, SHG, SMB, AT, AB, AM, ZS, MA, SG, RS, PC, NOG, CH, AG, BCDJ, and EH designed the study. Drafting the manuscript was performed by AY, NOG, EH, and BCDJ. All authors revised the manuscript. | PMC10169125 | |
Funding | This research will be funded by Janssen Pharmaceutica NV. The funders had no role in development, implementation, analysis of results, or preparation of the manuscript. | PMC10169125 | ||
Data Availability | The data supporting the findings of this publication will be retained at the Institute of Tropical Medicine, Antwerp, and will not be made openly accessible due to ethical and privacy concerns. Data can however be made available after approval of a motivated and written request to the Institute of Tropical Medicine at ... | PMC10169125 | ||
Declarations | PMC10169125 | |||
Ethics approval and consent to participate | The BE-PEOPLE trial was approved by ‘Comité National d’Ethique pour les Sciences de la Vie et de la Santé’ (CNESS) (Réf.N°23/03/CNESS/PR) as well as by the as well as by the ‘Direction Générale de la Santé’ (Réf.N°23/33/MSSPSPG/DGS) in the Union of Comoros. Approval was also received from the Institutional Review Board... | PMC10169125 | ||
Consent for publication | Not applicable. | PMC10169125 | ||
Competing interests | The authors have no competing interests to declare. | PMC10169125 | ||
List of Abbreviations | Tuberculosis | LEPROSY, TUBERCULOSIS | Adverse EventPhenolic glycolipid-IAdverse ReactionBacille de Calmette GuérinDamien FoundationInstitutional Review BoardInstitute of Tropical MedicineMulti bacillaryPaucibacillaryNational Tuberculosis and Leprosy Control ProgramPost ExpOsure Prophylaxis for LEprosy in the Comoros and MadagascarPost Exposure ProphylaxisQ... | PMC10169125 |
References | PMC10169125 | |||
Subject terms | gastroesophageal junction adenocarcinoma | REGRESSION, LIVER METASTASES, LIVER METASTASES, GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA | The liver is one of the most ordinary metastatic sites of gastroesophageal junction adenocarcinoma and significantly affects its prognosis. Therefore, this study tried to construct a nomogram that can be applied to predict the likelihood of liver metastases from gastroesophageal junction adenocarcinoma. 3001 eligible p... | PMC10329020 |
Introduction | gastroesophageal junction adenocarcinoma | GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA | The incidence of gastroesophageal junction adenocarcinoma (GEJA) has increased markedly in Western countries over the past few decades | PMC10329020 |
Methods | PMC10329020 | |||
Patients | LIVER METASTASES, GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA | We screened 3001 GEJA patients newly diagnosed between 2010 and 2015 from the SEER database who met our inclusion criteria, of which 281 developed liver metastases. The exclusion process is shown in Fig. Patient screening flowchart. This figure contains how we screened 3001 Siewert type II gastroesophageal junction ade... | PMC10329020 | |
Statistical analysis and optimal cutoffs | tumor | TUMOR | We used x-tile v3.6.1 (Yale University) software to determine optimal cutoff values for tumor size and age | PMC10329020 |
Results | PMC10329020 | |||
Characteristics of GEJA patients | tumor | TUMOR, LIVER METASTASES, BRAIN METASTASES, LUNG METASTASES, BONE METASTASES | We included 3001 patients with GEJA diagnosed between 2010 and 2015 in this retrospective study, with 9.3% (n = 281) had liver metastases, 3.5% (n = 106) had lung metastases, 2.5% (n = 77) had bone metastases, 0.4% (n = 14) had brain metastases. Table Characteristics of all 3001 patients before and after PSM.We used th... | PMC10329020 |
Survival analysis of liver metastases from gastroesophageal junction adenocarcinoma | gastroesophageal junction adenocarcinoma | LIVER METASTASES, GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA | Using R software v4.3.0, we performed a 1:3 propensity score matching of patients with gastroesophageal junction adenocarcinoma based on the presence or absence of liver metastases, and finally, 221 patients who had liver metastases were matched with 471 patients without liver metastases. The median follow-up for the p... | PMC10329020 |
The diagnostic likelihood of liver metastases in GEJA patients | tumor | REGRESSION, TUMOR, LIVER METASTASES | We randomly divided the patients into a training cohort and an internal validation cohort with an allocation of 7:3 ratio by R software v4.3.0. More information about the training and validation cohorts is shown in Table Patient characteristics of the training and validation cohorts.We used the x-tile v3.6.1 (Yale Univ... | PMC10329020 |
Construction and validation of a predicted nomogram | gastroesophageal junction adenocarcinoma, adenocarcinoma of the gastroesophageal junction | LIVER METASTASES, GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA, REGRESSION, LIVER METASTASIS, ADENOCARCINOMA OF THE GASTROESOPHAGEAL JUNCTION | Based on the risk factors for liver metastases identified by multivariate logistic regression, we created a nomogram to predict the risk of liver metastases in GEJA patients. (Fig. Nomogram to predict the risk of liver metastases in gastroesophageal junction adenocarcinoma patients. From this nomogram, we can determine... | PMC10329020 |
Discussion | tumor, T stage, colorectal cancer, gastroesophageal junction malignancies, liver metastases, Malignant tumors, gastric cancer | BRAIN METASTASIS, TUMOR, COLORECTAL CANCER, LIVER METASTASES, LUNG METASTASIS, MALIGNANT TUMOR, LUNG METASTASES, GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA, LYMPH NODE METASTASIS, REGRESSION, BONE METASTASES, GASTRIC CANCER | The survival of patients with metastatic Siewert type II GEJA is influenced by multiple factors, such as pathological type, age, metastatic pattern, degree of differentiation, and treatmentIn this retrospective study, a nomogram that can predict the risk of liver metastases resulting from GEJA was constructed. And its ... | PMC10329020 |
Acknowledgements | The authors thank the participants and their families in this study. | PMC10329020 | ||
Author contributions | M.Z., W.Y., BH., C.C., D.Z., and Y.Y. made substantial contributions to conception and design; M.Z., W.Y., C.C., D.Z., and Y.Y. made substantial contributions to the acquisition, analysis, and interpretation of data. All authors made substantial contributions to the drafting of the manuscript and revising of the manusc... | PMC10329020 | ||
Funding | Supported by Natural Science Foundation of Gansu Province (21JR1RA118) and Gansu Provincial Youth Science and Technology Fund (21JR1RA107, 18JR3RA305). | PMC10329020 | ||
Data availability | The datasets used and/or analyzed during the current study available from the corresponding author on reasonable request. It can also be downloaded directly from the SEER database. ( | PMC10329020 | ||
Competing interests | The authors declare no competing interests. | PMC10329020 | ||
References | PMC10329020 | |||
Subject terms | acute kidney injury | SECONDARY INFECTION | SARS-CoV-2 and its different variants caused a “wave and wave” pandemic pattern. During the first wave we demonstrated that standardized Brazilian green propolis extract (EPP-AF®) reduces length of hospital stay in adult patients with COVID-19. Afterwards, we decided to evaluate the impact of EPP-AF in hospitalized pat... | PMC10611696 |
Introduction | non-vaccinated | CORONAVIRUS, DISEASE, CORONAVIRUS DISEASE 2019, SEVERE ACUTE RESPIRATORY SYNDROME | Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been a significant concern regarding its global impact on healthcare settingsAfter the viral replication phase, there is an enormous immunological and inflammatory challenge since both innate and adaptive immu... | PMC10611696 |
Methods | PMC10611696 | |||
Trial design and oversight | BeeCovid2 was a randomized, double-blind, placebo-controlled clinical trial to evaluate safety and efficacy of EPP-AF in hospitalized patients with COVID-19 who were not in mechanical ventilation. The study was conducted at Hospital São Rafael, a tertiary 600-bed hospital in Salvador, Bahia, northeastern Brazil, from A... | PMC10611696 | ||
Participants | fungal infection, cancer, heart failure, human immunodeficiency virus, sepsis, hypersensitivity | SARS-COV-2 INFECTION, HUMAN IMMUNODEFICIENCY VIRUS, FUNGAL INFECTION, LIVER FAILURE, CANCER, HEART, HEART FAILURE, END-STAGE KIDNEY DISEASE, SEPTIC SHOCK, SEPSIS, HYPERSENSITIVITY | It was considered eligible to study participation patients aged 18–80 years hospitalized with SARS-CoV-2 infection, diagnosis confirmed by reverse transcriptase-polymerase chain reaction (RT-PCR) and symptoms starting within 14 days of the randomization date.Exclusion criteria included patients undergoing mechanical ve... | PMC10611696 |
Procedures | Trial randomization was stratified based on clinical parameters related to the need for supplemental oxygen as follows: no use of oxygen, catheter ≤ 5 L/min, nasal catheter > 5 L/min or non-rebreather mask, continuous positive airway pressure (CPAP), or high-flow nasal cannula. Randomization was carried out from permut... | PMC10611696 | ||
Outcomes | AKI, initiation of renal replacement, acute kidney injury | SECONDARY, SECONDARY INFECTION, ACUTE KIDNEY INJURY, KIDNEY DISEASE | The primary endpoint was the time to clinical improvement, defined as the difference in days in length of hospital stay between groups.The secondary outcomes included percentage of participants who needed mechanical ventilation (MV), secondary infection (defined as cultures of blood, urine or tracheal aspirate positive... | PMC10611696 |
Safety | death, Cancer | ADVERSE EVENT, ADVERSE EVENT, CANCER | Patients were monitored to ensure safety, which is the major premise of the entire study. Adverse events (AE) that may compromise safety or were regarded as serious or severe (pregnancy, life-threatening illness, new hospitalization, or death) were reported to the local research ethics committee (within 24 h). Adverse ... | PMC10611696 |
Statistical analysis | death | REGRESSION | The mean length of hospital stay in the control group of BeeCovid study was 12.6 days with a standard deviation of 6.5 daysThe main analysis of the study was conducted under the intention-to-treat principle. The modified intention-to-treat population consisted of all patients who were randomized and received either EPP... | PMC10611696 |
Results | PMC10611696 | |||
Discussion | critically ill, chronic kidney disease, fever, coronavirus infection, pain, infection, hemodialysisAcute kidney injury | CRITICALLY ILL, CORONAVIRUS INFECTION, DISEASES, INFECTION, SECONDARY INFECTION | In this randomized, double-blind, placebo-controlled study, the use of standardized Brazilian green propolis extract associated with standard-of-care treatment reduced the length of hospital stay by one day compared to a placebo group among hospitalized adult patients with mild to moderate COVID-19. This trend was more... | PMC10611696 |
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-43764-w. | PMC10611696 | ||
Acknowledgements | The authors thank the patients for their valuable contributions. The authors also thank Apis Flora Indl. Coml. Ltda. for providing propolis and placebo, the support of the Maria Emília Pedreira Freire de Carvalho Foundation, and the staff of D’Or Institute for Research and Education (IDOR) and Hospital São Rafael for t... | PMC10611696 |
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