A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of bebtelovimab for the treatment of mild-to-moderate coronavirus disease 2019 in adults and pediatric patients (12 years of age and older weighing at least 40 kg): • with positive results of direct SARS-CoV-2 viral testing, and • who are at high risk for progression to severe COVID-19, including hospitalization or death, and • for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. (14.4) LIMITATIONS OF AUTHORIZED USE • Bebtelovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to this drug and regional variant frequency. o FDA will monitor conditions to determine whether use in a geographic region is consistent with this scope of authorization, referring to available information, including information on variant susceptibility, and CDC regional variant frequency data available at: https://covid.cdc.gov/covid-data-tracker/#variant-proportions. (12.4) o FDA's determination and any updates will be available at: https://www.fda.gov/emergency-preparedness-andresponse/mcm-legal-regulatory-and-policy-framework/emergencyuse-authorization#coviddrugs • Bebtelovimab is not authorized for use in patients who: o are hospitalized due to COVID-19, OR o require oxygen therapy and/or respiratory support due to COVID-19, OR o require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity. Bebtelovimab is not approved for any use, including for use as treatment of COVID-19. (1) * Sections or subsections omitted from the EUA are not listed