Tocilizumab in Hospitalized Patients with Severe Covid-19 Pneumonia
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- Evaluated articles (Rapid Reviews Infectious Diseases)
Abstract
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SciScore for 10.1101/2020.08.27.20183442: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Informed consent was obtained for all enrolled patients.
IRB: The protocol was reviewed by institutional review boards or ethics committees.Randomization Trial Design and Oversight: COVACTA is a global, multicenter, randomized, double-blind, placebo-controlled, phase 3 trial investigating the efficacy and safety of tocilizumab in patients with severe COVID-19 pneumonia (ClinicalTrials.gov, NCT04320615). Blinding not detected. Power Analysis An estimated mITT population sample size of 450 patients randomized to tocilizumab or placebo was determined to give 90% power for the primary endpoint using the van Elteren test and an assumed distribution of the … SciScore for 10.1101/2020.08.27.20183442: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Informed consent was obtained for all enrolled patients.
IRB: The protocol was reviewed by institutional review boards or ethics committees.Randomization Trial Design and Oversight: COVACTA is a global, multicenter, randomized, double-blind, placebo-controlled, phase 3 trial investigating the efficacy and safety of tocilizumab in patients with severe COVID-19 pneumonia (ClinicalTrials.gov, NCT04320615). Blinding not detected. Power Analysis An estimated mITT population sample size of 450 patients randomized to tocilizumab or placebo was determined to give 90% power for the primary endpoint using the van Elteren test and an assumed distribution of the ordinal scale (Appendix 2). Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:The design and conduct of clinical trials in patients with COVID-19 present unique challenges and limitations. The COVACTA study population was intentionally chosen to be heterogeneous with regard to patient characteristics, previous/concurrent treatments, and disease severity to allow assessment of potential benefit across a broad range of patients and to reflect real-world practice in the expanding pandemic. Despite this heterogeneity, the proportion of patients discharged or ready for discharge by day 28 was higher in the tocilizumab arm than the placebo arm across the baseline ordinal scale of clinical status categories, whereas no consistent pattern was observed for mortality. The lack of standardized treatment across study sites and countries is an important limitation of this study considering potential interactions with antivirals and steroids. More patients in the placebo arm than the tocilizumab arm received concomitant steroids, which might have created bias toward lower mortality in the placebo arm22; however, this imbalance is unlikely to have obscured a significant treatment effect because the mortality rate was similar between treatment arms regardless of steroid use and was higher in patients who received steroids in both treatment arms than in those who did not (Table S2). Since our study was initiated, standard care treatment and understanding of the natural history of COVID-19 and its associated complications have evolved substantially. Based on current kno...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04320615 Completed A Study to Evaluate the Safety and Efficacy of Tocilizumab i… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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Imran Khan
Review 3: "Tocilizumab in Hospitalized Patients With COVID-19 Pneumonia"
An anti-interleukin-6 antibody, tocilizumab, was found to have no significant differences in mortality or clinical outcomes at day 28, but shorter median time to hospital discharge, compared with placebo in a rigorously conducted randomized control trial.
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