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Hospitalization and Anaphylaxis Following Monoclonal Antibodies (mAb) Use in Patients with COVID-19: A Descriptive Analysis

    Basic Details
    Date Posted
    Medical Product
    bamlanivimab etesevimab
    casirivimab imdevimab
    Health Outcome(s)

    This analysis is part of the ongoing effort to monitor the utilization of outpatient COVID-19 treatment under emergency use authorization (EUA). In this request we examined use of monoclonal antibodies (mAb) in the Rapid COVID Sentinel Distributed Database (SDD). This request had three Aims:

    • Aim 1: Characterize mAb users, mAb non-users, and COVID-19 patients
    • Aim 2: Estimate rates of hospitalization following outpatient mAb use
    • Aim 3: Estimate rates of anaphylaxis following mAb use

    The study period for Aims 1 and 2 includes data from November 9, 2020 up to June 30, 2021. The study period for Aim 3 includes data from November 9, 2020 up to September 30, 2021 (most recent available data). We distributed this request to six Sentinel Rapid COVID Data Partners on December 27, 2021.

    Additional Details
    FDA Center
    Time Period
    November 9, 2020 - June 30, 2021; November 9, 2020 - September 30, 2021
    Analysis Type
    Population / Cohort
    All individuals
    Data Sources
    Sentinel Distributed Database (SDD)