REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19

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Abstract

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  1. SciScore for 10.1101/2021.05.19.21257469: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The local institutional review board or ethics committee at each study center oversaw trial conduct and documentation.
    Consent: All patients provided written informed consent before participating in the trial.
    Sex as a biological variableThe phase 3 portion comprised 3 cohorts: Cohort 1 (≥18 years), Cohort 2 (<18 years), and Cohort 3 (pregnant at randomization).
    RandomizationTRIAL DESIGN: This was an adaptive, multicenter, randomized, double-blind, placebo-controlled, phase 1/2/3 master protocol in Covid-19 outpatients (NCT04425629).
    BlindingThe investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    All patients were assessed at baseline for anti-SARS-CoV-2 antibodies – anti-spike [S1] IgA, anti-spike [S1] IgG, and anti-nucleocapsid IgG – and grouped for analyses as serum antibody–negative (if all available test results were negative), serum antibody– positive (if any available test result was positive), or other (inconclusive/unknown results).
    anti-SARS-CoV-2
    suggested: None
    anti-spike [ S1
    suggested: None
    anti-spike [ S1 ] IgG
    suggested: None
    anti-nucleocapsid IgG
    suggested: None
    Software and Algorithms
    SentencesResources
    Statistical analyses were performed with SAS software, v9.4
    SAS
    suggested: (SASqPCR, RRID:SCR_003056)
    4 (SAS Institute).
    SAS Institute
    suggested: (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: 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
    NCT04425629RecruitingSafety, Tolerability, and Efficacy of Anti-Spike (S) SARS-Co…
    NCT04426695Active, not recruitingSafety, 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.