Comparison of safety and efficacy of convalescent plasma with fresh frozen plasma in severe covid-19 patients

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Abstract

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  1. SciScore for 10.1101/2020.10.25.20219337: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIACUC: The trial was approved by the Institutional Ethical Committees and was registered with ClinicalTrial.gov (identifier: NCT04346446).
    Consent: We collected 500ml Convalescent plasma (COPLA) from COVID-19 recovered patients after 14 days of complete resolution of symptoms by Plasmapheresis (MCS+, Hemonetics USA) after due consent.
    RandomizationTrial design and study setting: It was an open-labeled, phase II; pilot randomized controlled trial conducted to assess efficacy and safety of convalescent plasma at the Institute of Liver and Biliary Sciences (ILBS) and in collaboration with the Department of Internal Medicine, Lok Nayak Hospital, New Delhi, a designated COVID-19 treatment centre.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    The titres of spike protein S1 RBD IgG antibody was done by ELISA (SARS-CoV-2 Spike S1-RBD IgG Detection Kit, Genscript, USA) representing spike protein antibody, directed against the SARS-CoV-2 RBD (receptor binding domain) proteins.
    SARS-CoV-2 RBD (receptor binding domain) proteins.
    suggested: None
    The absorbance of the sample was inversely dependent on the titre of the anti-SARS-CoV2 neutralizing antibodies.
    anti-SARS-CoV2 neutralizing antibodies.
    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: We detected the following sentences addressing limitations in the study:
    Our study had certain limitations. We had fewer numbers of participants in this pilot trial thus we could not draw clear cut and robust conclusions. Secondly, one patient in the convalescent plasma group was already in renal failure. Third, all the patients were given Oseltamivir anti-viral and hydroxychloroquine despite the uncertainty of the efficacy as part of their standard care. Lastly, the dynamic changes in cytokines level during treatment were not investigated in an absolute controlled way. However, the preliminary results in the present pilot trial are encouraging and seem promising as early clinical recovery and shorter ICU, and hospital stay was observed in the convalescent plasma group. We need to conduct larger RCTs to draw conclusive evidence before advocating this mode of therapy.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04346446CompletedEfficacy of Convalescent Plasma Therapy in Severely Sick COV…


    Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).


    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.

    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.