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When President Trump received an infusion of a monoclonal antibody cocktail (REGN-COV2 from Regeneron) on October 2, 2020, his physicians were presumably reacting to promising data reported in the company’s news release from 3 days earlier. The company had announced the results of a trial involving 275 individuals randomized 1:1:1 to placebo, low-dose monoclonal antibody treatment, or high-dose treatment.1 Per the news release, those patients with high viral loads and those who had not already mounted their own antibody response showed a greater decrease in viral load and time to resolution of symptoms. Additional data on more important outcomes, including rates of hospitalization, development of serious illness, and mortality were not available. It was not clear, although unlikely, if the study was powered to detect these outcomes.
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Corresponding Author: Robert H. Goldstein, MD, PhD, Division of Infectious Diseases, Massachusetts General Hospital, 55 Fruit St, Cox 5, Boston, MA 02114 (email@example.com).
Published Online: November 11, 2020. doi:10.1001/jama.2020.21872
Conflict of Interest Disclosures: None reported.
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