November 2, 2020 -- The independent data monitoring committee of the REGN-COV2 antibody cocktail treatment trials for COVID-19 has recommended holding enrollment in hospitalized patients with high oxygen requirements and continuing enrollment in patients with low or no oxygen requirements.
The decision is based on a potential safety signal and an unfavorable risk/benefit profile at this time. The committee recommended further collection and data analysis of patients already enrolled. Lastly, the committee recommended continuing the outpatient trial without modification.
Regeneron Pharmaceuticals, the firm spearheading the trial, remains blinded to the data and is implementing the committee's recommendations. The firm is also informing the U.S. Food and Drug Administration (FDA), which is currently evaluating REGN-COV2 for a potential emergency use authorization (EUA) in mild-to-moderate outpatients at high risk for poor outcomes. Regeneron is also sharing the recommendation with the independent committee monitoring the Recovery trial in the U.K.