Early Experience With Neutralizing Monoclonal Antibody Therapy For COVID-19

  1. Mark Jarrett
  2. Warren B. Licht
  3. Kevin Bock
  4. Zenobia Brown
  5. Jamie S. Hirsch
  6. Kevin Coppa
  7. Rajdeep Brar
  8. Steven Bello
  9. Ira S. Nash

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Abstract

Importance

Neutralizing monoclonal antibody (MAB) therapies may benefit patients with mild to moderate COVID-19 at high risk for progressing to severe COVID-19 and/or hospitalization. Studies documenting approaches to deliver MAB infusions as well as demonstrating their efficacy are lacking.

Objective

We describe our experience and patient outcomes of almost 3,000 patients who received MAB infusion therapy at Northwell Health, a large integrated health care system in New York.

Design, Setting, and Participants

This is a descriptive study of adult patients who received MAB therapy between November 20, 2020, to January 31, 2021, and a retrospective cohort survival analysis comparing patients who received MAB therapy prior to admission versus those who did not. A multivariable Cox model with inverse probability weighting according to the propensity score including covariates (sociodemographic, comorbidities, and presenting vital signs) was used.

Main outcomes and measures

The primary outcome was in-hospital mortality; additional evaluations included ED utilization and hospitalization within 28 days of a positive COVID-19 test for patients who received MAB therapy.

Results

During the study period, 2818 adult patients received MAB infusion. Following therapy and within 28 days of COVID-19 test, 123 patients (4.4%) presented to the ED and were released and 145 patients (5.1%) were hospitalized. These 145 patients were compared with 200 controls who were eligible for but did not receive MAB therapy, and were hospitalized. In the MAB group, 16 (11%) patients met the primary outcome of in-hospital mortality, versus 21 (10.5%) in the control group. In an unadjusted Cox model, the hazard ratio (HR) for time to in-hospital mortality for the MAB group was 1.38 (95% confidence interval [95% CI] 0.696-2.719). Models adjusting for demographics (HR 1.1, 95% CI 0.53-2.23), demographics and Charlson Comorbidity Index (CCI) (HR 1.22, 95% CI 0.573-2.59), and with inverse probability weighting according to propensity scores (HR 1.19, 95% CI 0.619-2.29) did not demonstrate significance. The hospitalization rate was 4.4% for patients who received MAB therapy within 0-4 days, 5% within 5-7 days, and 6.1% within ≥8 days of symptom onset (p-value = 0.15).

Conclusions and relevance

Establishing the capability to provide neutralizing MAB infusion therapy requires significant planning and coordination. While this therapy may be an important treatment option for early mild to moderate COVID-19 in high-risk patients, further investigations are needed to define the optimal timing of MAB treatment in order to reduce hospitalization and mortality.

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  1. ScreenIT

    SciScore for 10.1101/2021.04.09.21255219: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The Institutional Review Board of Northwell Health approved the study protocol before the commencement of the study.
    Consent: Individual-level informed consent was not obtained given the retrospective nature of the analysis of a large electronic medical record.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    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: We detected the following sentences addressing limitations in the study:
    Limitations: Limitations of our study include the observational and retrospective study design. In addition, our health system is based in New York and may not be generalizable to other regions. Due to the lack of symptom documentation for our control group of patients, we were unable to assess the impact of MAB therapy on hospitalization rate. Given the small number of patients and low event rate, our analysis of inpatient mortality may be underpowered to detect a difference.

    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 10.1101/2021.04.09.21255219 on medRxiv