Convalescent Plasma for Patients With Severe Coronavirus Disease 2019 (COVID-19): A Matched Cohort Study

  1. Ralph Rogers
  2. Fadi Shehadeh
  3. Evangelia K Mylona
  4. Josiah Rich
  5. Marguerite Neill
  6. Francine Touzard-Romo
  7. Sara Geffert
  8. Jerome Larkin
  9. Jeffrey A Bailey
  10. Shaolei Lu
  11. Joseph Sweeney
  12. Eleftherios Mylonakis

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Abstract

Background

The efficacy of convalescent plasma (CP) for the treatment of coronavirus disease 2019 (COVID-19) remains unclear.

Methods

In a matched cohort analysis of hospitalized patients with severe COVID-19, the impact of CP treatment on in-hospital mortality was evaluated using univariate and multivariate Cox proportional-hazards models, and the impact of CP treatment on time to hospital discharge was assessed using a stratified log-rank analysis.

Results

In total, 64 patients who received CP a median of 7 days after symptom onset were compared to a matched control group of 177 patients. The incidence of in-hospital mortality was 12.5% and 15.8% in the CP and control groups, respectively (P = .52). There was no significant difference in the risk of in-hospital mortality between the 2 groups (adjusted hazard ratio [aHR] 0.93, 95% confidence interval [CI] .39–2.20). The overall rate of hospital discharge was not significantly different between the 2 groups (rate ratio [RR] 1.28, 95% CI .91–1.81), although there was a significantly increased rate of hospital discharge among patients 65-years-old or greater who received CP (RR 1.86, 95% CI 1.03–3.36). There was a greater than expected frequency of transfusion reactions in the CP group (2.8% reaction rate observed per unit transfused).

Conclusions

We did not demonstrate a significant difference in risk of mortality or rate of hospital discharge between the CP and control groups. There was a signal for improved outcomes among the elderly, and further adequately powered randomized studies should target this subgroup when assessing the efficacy of CP treatment.

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  1. ScreenIT

    SciScore for 10.1101/2020.08.18.20177402: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: This matched cohort study was an electronic chart review approved by the Institutional Review Board of RIH.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Due to limitations in locally available serologic testing at the time, CP was given to patients prior to knowing the SARS-CoV-2 antibody content.
    SARS-CoV-2
    suggested: None
    Software and Algorithms
    SentencesResources
    Instead, SARS-CoV-2 antibody content was assessed retrospectively on thawed segments (if available) using the Abbott Architect SARS-CoV-2 IgG assay (Abbott, Abbott Park, IL).
    Abbott Architect
    suggested: (Abbott ARCHITECT i1000sr System, RRID:SCR_019328)
    Abbott
    suggested: (Abbott, RRID:SCR_010477)

    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:
    Though our study had several limitations, we found no overall difference in in-hospital mortality or in time to hospital discharge for those patients who received CP as compared to those who did not. A secondary analysis showed a significantly increased rate of hospital discharge for CP given to patients 65-years-old or greater. While manufactured hyperimmune globulin or monoclonal antibodies may eventually supplant CP in the developed world, CP may remain a more cost-effective and feasible option in the developing world as it can be manufactured locally. Moving forward, it will be important to keep in mind a relevant transfusion medicine principle: give the right blood (plasma containing an adequate concentration of antibody) to the right patient (perhaps older adults or those with immunocompromising conditions) at the right time (early in the course of disease). We anxiously await the results of several ongoing randomized trials of CP taking place across the globe to help gain further insight into this therapy.

    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 10.1093/cid/ciaa1548
  3. Version published to 10.1101/2020.08.18.20177402v1 on medRxiv