Effect of Subcutaneous Casirivimab and Imdevimab Antibody Combination vs Placebo on Development of Symptomatic COVID-19 in Early Asymptomatic SARS-CoV-2 Infection

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Abstract

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  1. SciScore for 10.1101/2021.06.14.21258569: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: All participants provided written informed consent.
    Field Sample Permit: Safety endpoints included the collection of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and adverse events of special interest (AESIs) defined as grade ≥3 injection site reactions or hypersensitivity reactions.
    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 REGEN-COV in (Part A) preventing SARS-CoV-2 infection among uninfected household contacts of infected individuals and in (Part B) treating recently infected asymptomatic patients in the same households (ClinicalTrials.gov number, NCT04452318).
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    RT-qPCR was used to determine whether the patient had an ongoing SARS-CoV-2 infection, while baseline serology testing for serum anti-SARS-CoV-2 antibodies (anti-spike [S1] IgA, anti-spike [S1] IgG, and anti-nucleocapsid IgG) was used to determine a prior history of infection or an ongoing infection in which an endogenous antibody immune response had already occurred (i.e., seropositive; as opposed to seronegative).
    anti-SARS-CoV-2
    suggested: None
    anti-spike [S1] IgA
    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…


    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.