Hospitalized COVID-19 Patients Requiring No or Low-Flow Oxygen Enrollment Remains Acceptable

Regeneron Pharmaceuticals, Inc. announced it received on October 30, 2020, a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified.

Specifically, based on a potential safety signal and an unfavorable risk/benefit profile at this time, the IDMC recommends further enrollment of patients requiring high-flow oxygen or mechanical ventilation be placed on hold pending collection and analysis of further data on patients already enrolled.

The IDMC also recommends continuing enrollment of hospitalized patients requiring either no or low-flow oxygen as the risk/benefit remains acceptable in these cohorts. Finally, the IDMC recommends the continuation of the outpatient trial without modification.

Regeneron stated it is also informing the U.S. FDA, which is currently evaluating the REGN-COV2 treatment for a potential emergency authorization in mild-to-moderate outpatients at high risk for poor outcomes.