Convalescent Plasma for Preventing Critical Illness in COVID-19: a Phase 2 Trial and Immune Profile
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Abstract
Transfusion of high-titer CIP to non-critically ill patients early after admission with COVID-19 respiratory disease was associated with significantly increased anti-SARS-CoV-2 specific antibodies (compared to baseline) and a non-significant reduction in ICU transfer and death (compared to controls). This prospective phase II trial provides a suggestion that the antiviral effects of CIP from early in the COVID-19 pandemic may delay progression to critical illness and death in specific patient populations.
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SciScore for 10.1101/2021.02.16.21251849: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: This study received approval from the University of Virginia Institutional Review Board (#200114), was conducted under the FDA IND BB-20867, and registered at clinicaltrials.gov, NCT04374565. Randomization not detected. Blinding Controls were then reviewed by clinicians with expertise in Pulmonary & Critical Care and/or Infectious Diseases (JMS, SKH, TAT) who were provided History and Physical documentation, but were blinded to patient outcomes. Power Analysis An enrollment target of 29 patients was calculated to provide 80% power to detect a 50% reduction in the primary outcome using early historical targets of ICU admission from reports in China and elsewhere … SciScore for 10.1101/2021.02.16.21251849: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: This study received approval from the University of Virginia Institutional Review Board (#200114), was conducted under the FDA IND BB-20867, and registered at clinicaltrials.gov, NCT04374565. Randomization not detected. Blinding Controls were then reviewed by clinicians with expertise in Pulmonary & Critical Care and/or Infectious Diseases (JMS, SKH, TAT) who were provided History and Physical documentation, but were blinded to patient outcomes. Power Analysis An enrollment target of 29 patients was calculated to provide 80% power to detect a 50% reduction in the primary outcome using early historical targets of ICU admission from reports in China and elsewhere (13, 14). 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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04374565 Active, not recruiting Convalescent Plasma for Treatment of COVID-19 Patients With … 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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