Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19

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Abstract

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  1. SciScore for 10.1101/2021.06.14.21258567: (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.
    RandomizationTrial Design: This randomized, double-blind, placebo-controlled, two-part, phase 3 trial assessed the efficacy and safety of subcutaneous REGEN-COV in (Part A) preventing SARS-CoV-2 infection among uninfected household contacts of infected individuals and (Part B) also in treating recently infected asymptomatic patients (ClinicalTrials.gov number, NCT04452318).
    Blindingnot detected.
    Power AnalysisSimulations showed that approximately 1248 seronegative participants from 430 households (assuming an average household size of 2.9 participants) would provide >90% power to detect a relative risk of 0.5 (50% risk reduction of the assumed 10% attack rate in the placebo group), equivalent to an odds ratio of 0.47 at a two-sided alpha of 0.05.

    Table 2: Resources

    Antibodies
    SentencesResources
    RT-qPCR was used to determine ongoing infection with SARS-CoV-2, while serology (anti-spike [S1] IgA, anti-spike [S1] IgG, and/or anti-nucleocapsid IgG) determined a prior or ongoing infection in which an innate antibody immune response had already occurred (i.e., seropositive; as opposed to seronegative).
    anti-spike [S1
    suggested: None
    anti-spike [S1] IgG
    suggested: None
    anti-nucleocapsid IgG
    suggested: None

    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
    NCT04452318Active, not recruitingCOVID-19 Study Assessing the Efficacy and Safety of Anti-Spi…
    NCT04425629RecruitingSafety, Tolerability, and Efficacy of Anti-Spike (S) SARS-Co…


    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.