A Multicenter, Prospective, Observational, Cohort-Controlled Study of Clinical Outcomes Following Coronavirus Disease 2019 (COVID-19) Convalescent Plasma Therapy in Hospitalized Patients With COVID-19

  1. Lakshmi Chauhan
  2. Jack Pattee
  3. Joshay Ford
  4. Chris Thomas
  5. Kelsey Lesteberg
  6. Eric Richards
  7. Carl A Bernas
  8. Michele Loi
  9. Larry Dumont
  10. Kyle Annen
  11. Mary Berg
  12. Mercedes Zirbes
  13. Vijaya Knight
  14. Amanda Miller
  15. Timothy C Jenkins
  16. Tellen D Bennett
  17. Daniel Monkowski
  18. Rebecca S Boxer
  19. J David Beckham

Reviewed by

Read the full article See related articles

Listed in

Log in to save this article

Abstract

Background

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has caused high inpatient mortality and morbidity throughout the world. COVID-19 convalescent plasma (CCP) has been utilized as a potential therapy for patients hospitalized with coronavirus disease 2019 (COVID-19) pneumonia. This study evaluated the outcomes of hospitalized patients with COVID-19 treated with CCP in a prospective, observational, multicenter trial.

Methods

From April through August 2020, hospitalized patients with COVID-19 at 16 participating hospitals in Colorado were enrolled and treated with CCP and compared with hospitalized patients with COVID-19 who were not treated with convalescent plasma. Plasma antibody levels were determined following the trial, given that antibody tests were not approved at the initiation of the trial. CCP-treated and untreated hospitalized patients with COVID-19 were matched using propensity scores followed by analysis for length of hospitalization and inpatient mortality.

Results

A total of 542 hospitalized patients with COVID-19 were enrolled at 16 hospitals across the region. A total of 468 hospitalized patients with COVID-19 were entered into propensity score matching with 188 patients matched for analysis in the CCP-treatment and control arms. Fine-Gray models revealed increased length of hospital stay in CCP-treated patients and no change in inpatient mortality compared with controls. In subgroup analysis of CCP-treated patients within 7 days of admission, there was no difference in length of hospitalization and inpatient mortality.

Conclusions

These data show that treatment of hospitalized patients with COVID-19 treated with CCP did not significantly improve patient hospitalization length of stay or inpatient mortality.

Article activity feed

  1. Version published to 10.1093/cid/ciab834
  2. ScreenIT

    SciScore for 10.1101/2021.06.14.21258910: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: All patients or designated decision makers provided signed informed consent prior to enrollment into expanded access programs to receive CCP.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Levels of binding antibodies were assessed using VITROS anti-SARS CoV2 IgG assay.
    anti-SARS
    suggested: None
    Software and Algorithms
    SentencesResources
    As previously described, all patient data was entered and maintained in a secure, HIPAA-compliant REDCap database.[
    REDCap
    suggested: (REDCap, RRID:SCR_003445)
    We conducted greedy nearest neighbor one-to-one propensity score matching via the R package MatchIt.[15] A caliper length of 0.2 multiplied by the standard deviation of the logit of the propensity score was used.[
    MatchIt.
    suggested: None
    Inference is done via a Fine-Gray model for competing risks with robust variance estimation for the propensity-matched cohorts (http://github.com).
    http://github.com
    suggested: (GitHub, RRID:SCR_002630)

    Results from OddPub: Thank you for sharing your data.

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Weaknesses of the study include the open-label, non-randomized study design and lack of a placebo control group. While all CCP was evaluated for presence of SARS-CoV2 specific antibody, many of the units were retrospectively tested through individual regional plasma donation centers resulting in variability in the data. However, this approach also represented CCP treatment and distribution in the community during the pandemic.

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

    IdentifierStatusTitle
    NCT04471051CompletedAn Observational Cohort Trial of Outcomes and Antibody Respo…

    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.

  3. Version published to 10.1101/2021.06.14.21258910v1 on medRxiv