COVID-19 Convalescent Plasma and Clinical Trials: Understanding Conflicting Outcomes

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Abstract

Convalescent plasma (CP) recurs as a frontline treatment in epidemics because it is available as soon as there are survivors. The COVID-19 pandemic represented the first large-scale opportunity to shed light on the mechanisms of action, safety, and efficacy of CP using modern evidence-based medicine approaches. Studies ranging from observational case series to randomized controlled trials (RCTs) have reported highly variable efficacy results for COVID-19 CP (CCP), resulting in uncertainty.

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  1. SciScore for 10.1101/2021.09.07.21263194: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    RandomizationEach study was analyzed for the following variables: NCT identifier, recruitment, randomization strategy, type of control arm, baseline patient status, median neutralizing antibody (nAb) titer in both recipients (before CCP transfusion) and CCP units, type of viral neutralization test (VNT), primary endpoint, signals of efficacy, and reasons for failure At the same date, the ClinicalTrials.gov database was searched for CCP RCTs worldwide having as status “completed”, “active, not yet recruiting” or “recruiting”.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    On September 7, 2021, we searched PubMed (which is also indexing the medrXiv prepublishing server) for clinical trials of CCP in COVID19, focusing on RCTs and PSM studies only.
    PubMed
    suggested: (PubMed, RRID:SCR_004846)

    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:

    IdentifierStatusTitle
    NCT04359810CompletedPlasma Therapy of COVID-19 in Severely Ill Patients
    NCT04338360Approved for marketingExpanded Access to Convalescent Plasma for the Treatment of …
    NCT04361253TerminatedEvaluation of SARS-CoV-2 (COVID-19) Antibody-containing Plas…
    NCT04421404CompletedEffects of COVID-19 Convalescent Plasma (CCP) on Coronavirus…
    NCT04397757CompletedCOVID-19 Convalescent Plasma for the Treatment of Hospitaliz…


    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.

    Results from scite Reference Check: We found no unreliable references.


    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.