Hyperimmune Globulin for Severely Immunocompromised Patients Hospitalized With Coronavirus Disease 2019: A Randomized, Controlled Trial

  1. Sammy Huygens
  2. Quincy Hofsink
  3. Inger S Nijhof
  4. Abraham Goorhuis
  5. Arnon P Kater
  6. Peter A W te Boekhorst
  7. Francis Swaneveld
  8. Věra M J Novotný
  9. Susanne Bogers
  10. Matthijs R A Welkers
  11. Grigorios Papageorgiou
  12. Bart J Rijnders
  13. Jarom Heijmans

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Abstract

Background

The aim of this randomized, controlled trial is to determine whether antisevere acute respiratory syndrome coronavirus 2 hyperimmune globulin (COVIG) protects against severe coronavirus disease 2019 (COVID-19) in severely immunocompromised, hospitalized, COVID-19 patients.

Methods

Patients were randomly assigned to receive COVIG or intravenous immunoglobulin (IVIG) without SARS-CoV-2 antibodies.

Results

Severe COVID-19 was observed in 2 of 10 (20%) patients treated with COVIG compared to 7 of 8 (88%) in the IVIG control group (P = .015, Fisher’s exact test).

Conclusions

Antisevere acute respiratory syndrome coronavirus 2 hyperimmune globulin may be a valuable treatment in severely immunocompromised, hospitalized, COVID-19 patients and should be considered when no monoclonal antibody therapies are available.

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  1. Version published to 10.1093/infdis/jiac334
  2. ScreenIT

    SciScore for 10.1101/2022.04.04.22273314: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The protocol was approved by the medical ethics committees of all participating centres, and written informed consent was obtained from all patients.
    Consent: The protocol was approved by the medical ethics committees of all participating centres, and written informed consent was obtained from all patients.
    Sex as a biological variablenot detected.
    RandomizationStudy design and participants: The COVID-Compromise trial was a randomised, controlled, double-blind, multicentre, phase 3 trial to evaluate the effects of COVIG in severely immunocompromised patients hospitalised with COVID-19.
    BlindingAll investigators, research staff, and participants were blinded to the allocated treatment until day 28, but unblinding was possible before day 28 when the primary endpoint was reached.
    Power AnalysisWith a power of 90% and a two-sided alpha of 5% and a single pre-planned efficacy interim analysis, a sample size of 86 participants was required.

    Table 2: Resources

    No key resources detected.

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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.

    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 10.1101/2022.04.04.22273314 on medRxiv