Wed. Dec. 23, 2020 Preliminary results of a Phase 3, randomized, placebo-controlled clinical trial testing the investigative monoclonal antibody LY-CoV555 in hospitalized COVID-19 patients were published in the New England Journal of Medicine. The antibody did not provide clinical benefit compared to placebo. The trial, which had been halted to new enrollment in late October following a recommendation by the independent Data and Safety Monitoring Board (DSMB), is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. Although LY-CoV555 did not perform better than placebo in the hospitalized COVID-19 patients studied in this trial, this same investigational monoclonal antibody was granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration in November. The EUA authorized use of LY-CoV555 in non-hospitalized adolescents and adults with mild to moderate COVID-19 symptoms who are at elevated risk of progressing to severe COVID-19 disease. |
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