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The Challenges Ahead With Monoclonal AntibodiesFrom Authorization to Access

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

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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Article Information

Corresponding Author: Robert H. Goldstein, MD, PhD, Division of Infectious Diseases, Massachusetts General Hospital, 55 Fruit St, Cox 5, Boston, MA 02114 (rgoldstein3@partners.org).

Published Online: November 11, 2020. doi:10.1001/jama.2020.21872

Conflict of Interest Disclosures: None reported.

References
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Regeneron’s REGN-COV2 antibody cocktail reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients. News release. Regeneron; September 29, 2020. Accessed October 17, 2020. https://investor.regeneron.com/news-releases/news-release-details/regenerons-regn-cov2-antibody-cocktail-reduced-viral-levels-and
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Gilead announces results from phase 3 trial of investigational antiviral remdesivir in patients with severe COVID-19. News release. Gilead Sciences Inc; April 29, 2020. Accessed October 17, 2020. https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/gilead-announces-results-from-phase-3-trial-of-investigational-antiviral-remdesivir-in-patients-with-severe-covid-19
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Walker  J , Loftus  P . Antibody drugs touted by Trump could be next to get authorized for COVID-19. Wall Street Journal. October 9, 2020. Accessed October 17, 2020. https://www.wsj.com/articles/antibody-drugs-touted-by-trump-could-be-next-to-get-authorized-for-covid-19-11602235803
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