A randomized double-blind controlled trial of convalescent plasma in adults with severe COVID-19
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SciScore for 10.1101/2021.03.12.21253373: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The trial was conducted in accordance with Good Clinical Practice guidelines, the Declaration of Helsinki, and the Brazilian National Ethics Committee Resolution 466/12.
Consent: Written informed consent was obtained from all participants or from their legally authorized representative.Randomization Study Design: This was an investigator-initiated, randomized, double-blind, controlled trial to evaluate the efficacy and safety of convalescent plasma among adults hospitalized with severe COVID-19. Blinding The clinical teams directly managing patients and the trial clinicians who adjudicated clinical status and determined 28-day outcomes were blinded to … SciScore for 10.1101/2021.03.12.21253373: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The trial was conducted in accordance with Good Clinical Practice guidelines, the Declaration of Helsinki, and the Brazilian National Ethics Committee Resolution 466/12.
Consent: Written informed consent was obtained from all participants or from their legally authorized representative.Randomization Study Design: This was an investigator-initiated, randomized, double-blind, controlled trial to evaluate the efficacy and safety of convalescent plasma among adults hospitalized with severe COVID-19. Blinding The clinical teams directly managing patients and the trial clinicians who adjudicated clinical status and determined 28-day outcomes were blinded to treatment allocation. Power Analysis With a 2:1 randomization ratio and a total sample size of 219 participants (146 in the convalescent plasma arm versus 73 in the control arm), we determined that a one-sided Mann-Whitney test at a level of 15% would have 82% power to detect an OR 1.7. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Procedures: Convalescent plasma used at all study sites was collected by the New York Blood Center from patients who had recovered from laboratory-confirmed COVID-19, provided informed consent, had a minimum anti-SARS-CoV-2 total IgG antibody titer of ≥1:400 by quantitative enzyme linked immunosorbent assay against the spike protein (16), were at least 14 days asymptomatic following resolution of COVID-19, and had a negative PCR test for SARS-CoV-2 from a nasopharyngeal swab. anti-SARS-CoV-2 total IgGsuggested: NonePost hoc subgroup analyses were performed according to study country, age, sex, concomitant treatment with corticosteroids, and by titers of neutralizing anti-SARS-CoV-2 antibody in infused convalescent plasma units. anti-SARS-CoV-2suggested: NoneSoftware and Algorithms Sentences Resources Analyses were performed using SAS, version 9.4 (SAS Institute, Cary, NC, USA). SASsuggested: (SASqPCR, RRID:SCR_003056)SAS Institutesuggested: (Statistical Analysis System, RRID:SCR_008567)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:Considering power limitations of our trial, we observed similar trends towards improvement in the primary outcome among patients in the convalescent plasma group transfused within 7 days of symptom onset and those who received convalescent plasma with higher-titers of neutralizing anti-SARS-CoV-2 antibody. In the context of emerging SARS-CoV-2 variants, some of which may be associated with greater transmissibility and more severe illness (20), convalescent plasma may offer distinct therapeutic advantages. Since convalescent plasma, which contains polyclonal antibodies, may be donated and transfused locally, and its use may be more adaptable to rapidly changing local viral ecology than other interventions. In contrast, monoclonal antibody therapies may need to be repeatedly engineered and combined to optimize potency among emergent SARS-CoV-2 variants (21,22). Further, since collection and distribution of convalescent plasma units can be performed using existing blood donation protocols and infrastructure, convalescent plasma may be more scalable for use in low- and middle-income countries. Although clinical status at 28 days was not significantly different between treatment groups, 28-day mortality was significantly lower among patients randomized to receive convalescent plasma. Although this secondary outcome was pre-specified, our study was not powered to detect a difference in mortality and analyses of our secondary outcomes were not adjusted for multiplicity. This finding...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04359810 Recruiting Plasma Therapy of COVID-19 in Severely Ill Patients 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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