This week, Regeneron Pharmaceuticals have shown to put a hold on enrolling patients in the trial of REGN-COV2, where they are testing an antibody cocktail therapy for treating hospitalized patients who require high-flow oxygen or mechanical ventilation. REGN-COV2 is known to be a combination of two monoclonal antibodies named REGN10933 and REGN10987 and can block the infectivity of SARS-COV-2, the virus that causes Covid-19.
This decision follows the recommendations of an independent data monitoring committee (IDMC) based on a potential safety signal and an unfavorable risk/benefit profile at this time. Following the recommendation of the committee, Regeneron will continue to enroll hospitalized patients who are only requiring no oxygen or only low-flow oxygen. Regeneron underlined that the trial for hospitalized patients has been divided into four cohorts that are independently randomized. This means cohort 1 involved patients who require low-flow oxygen and cohort 1A will include patients who are not in need of oxygen.
The FDA (US Food and Drug Administration) is currently reviewing the antibody cocktail for potential emergency use authorization (EUA) in mild to moderate outpatients at high risk for poor outcomes.
The recommendation of the committee will also be a baseline for the decision of the independent committee, which is monitoring the RECOVERY trial evaluating REGN-COV2 in hospitalized patients in the United Kingdom.
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