Significantly Decreased Mortality in a Large Cohort of Coronavirus Disease 2019 (COVID-19) Patients Transfused Early with Convalescent Plasma Containing High-Titer Anti–Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike Protein IgG

  1. Eric Salazar
  2. Paul A. Christensen
  3. Edward A. Graviss
  4. Duc T. Nguyen
  5. Brian Castillo
  6. Jian Chen
  7. Bevin V. Lopez
  8. Todd N. Eagar
  9. Xin Yi
  10. Picheng Zhao
  11. John Rogers
  12. Ahmed Shehabeldin
  13. David Joseph
  14. Faisal Masud
  15. Christopher Leveque
  16. Randall J. Olsen
  17. David W. Bernard
  18. Jimmy Gollihar
  19. James M. Musser

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Abstract

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  1. ScreenIT

    SciScore for 10.1101/2020.10.02.20206029: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: We analyzed data from patients cared for in all eight Houston Methodist hospitals from March 28, 2020, through September 14, 2020, with the approval of the Houston Methodist Research Institute ethics review board and with written informed consent of the patient or legally authorized representative.
    Consent: We analyzed data from patients cared for in all eight Houston Methodist hospitals from March 28, 2020, through September 14, 2020, with the approval of the Houston Methodist Research Institute ethics review board and with written informed consent of the patient or legally authorized representative.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    3 Convalescent plasma donors, antibody titer assessment, and donor unit selection: Detailed protocols for convalescent plasma collection and anti-spike protein titer assessment have been described.
    anti-spike protein
    suggested: None
    Software and Algorithms
    SentencesResources
    All analyses were performed with Stata version 16.1
    Stata
    suggested: (Stata, RRID:SCR_012763)
    1 (StataCorp LLC, College Station, TX, USA) or the R Statistical Computing environment (http://www.R-project.org/).
    StataCorp
    suggested: (Stata, RRID:SCR_012763)

    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:
    The current analysis addressed several limitations we identified in our interim analysis.3 First, the patient sample size is almost three times as large as that included in our interim analysis. Second, we included additional covariates in the propensity score matching algorithm, including relevant concomitant medications (any steroid, azithromycin, hydroxychloroquine, remdesivir, ribavirin, and tocilizumab). Importantly, factors identified as having a significant adjusted HR for mortality for all hospitalized COVID-19 patients were included in the propensity match. Third, because a large proportion of deaths occurred after 28 days post-Day 0, we assessed a 60-day outcome. Fourth, control patients enrolled in other clinical trials involving alternative experimental therapies were excluded. Fifth, when possible, we performed multivariate analyses assessing factors associated with mortality within 60 days. Finally, we used ROC analysis with Youden index to identify the optimal cut point at which transfusion of convalescent plasma is most useful with respect to altering mortality. Our results bear on other recent studies treating patients with convalescent plasma.4, 9, 13-16 For example, a recent fixed-effect meta-analysis model assessing 12 controlled studies of COVID-19 convalescent plasma found that the aggregate mortality rate of transfused COVID-19 patients was significantly lower than that of non-transfused patients.4 Results from three randomized controlled studies and on...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    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.

  2. Version published to 10.1016/j.ajpath.2020.10.008
  3. Version published to 10.1101/2020.10.02.20206029v1 on medRxiv