Factors Associated with Good Patient Outcomes Following Convalescent Plasma in COVID-19: A Prospective Phase II Clinical Trial

  1. Danyal Ibrahim
  2. Latha Dulipsingh
  3. Lisa Zapatka
  4. Reginald Eadie
  5. Rebecca Crowell
  6. Kendra Williams
  7. Dorothy B. Wakefield
  8. Lisa Cook
  9. Jennifer Puff
  10. Syed A. Hussain

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Abstract

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  1. Version published to 10.1007/s40121-020-00341-2
  2. ScreenIT

    SciScore for 10.1101/2020.08.27.20183293: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: Informed consent was provided by either the patient or the patient’s legally authorized representative (LAR).
    IRB: The protocol was approved by the Trinity Health Of New England Institutional Review Board (#SFH-20-23).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    SAS software version 9.4 (SAS Institute Inc., Cary, NC, USA) was used for analyses.
    SAS
    suggested: (SASqPCR, RRID:SCR_003056)
    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: We detected the following sentences addressing limitations in the study:
    Important limitations in this study include open-label, no control group and modest sample size. However, this early report is important as it meaningfully contributes to the questions whether convalescent plasma is safe and it sheds light on important factors that are associated with favorable outcomes including recovery and survival. Conclusions: For patients with severe or critical COVID-19 disease, convalescent plasma from recovered COVID-19 patients is safe and has the potential for positive impact on clinical outcomes including recovery and survival if given early in course of disease. Our study makes a strong case for the importance of pursing a randomized placebo control trial focused on enrolling patients early in the course of their disease to further explore experimentally the efficacy and effectiveness of convalescent plasma in Covid-19.

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

    IdentifierStatusTitle
    NCT04343261CompletedConvalescent Plasma in the Treatment of COVID 19

    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.

    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.

  3. Version published to 10.1101/2020.08.27.20183293v1 on medRxiv