Effect of Bamlanivimab vs Placebo on Incidence of COVID-19 Among Residents and Staff of Skilled Nursing and Assisted Living Facilities

作者：Myron S. Cohen, Ajay Nirula, Mark J. Mulligan, Richard Novák, Mary Marovich, Catherine Yen, Alexander Stemer, Stockton Mayer, David A. Wohl, Blair Brengle, Brian T. Montague, Ian Frank, Russell J. McCulloh, Carl J. Fichtenbaum, Brad Lipson, Nashwa Gabra, Julio A. Ramírez, Christine Thai, Wairimu Chege, Margarita M. Gomez Lorenzo, Nirupama Sista, Jennifer Farrior, Meredith E. Clement, Elizabeth R. Brown, Kenneth L. Custer, Jacob Van Naarden, Andrew C. Adams, Andrew E. Schade, Matan C. Dabora, Jack Knorr, Karen Price, Janelle Sabo, Jay Tuttle, Paul Klekotka, Lei Shen, Daniel Skovronsky, BLAZE-2 Investigators, Kwadwo-Agyei Gyamfi, Jason Begue, Scott Borgetti, Greer Burkholder, Srilatha Edupuganti, Kathleen Gannon, Christopher J. Hall, V. G. Horstman, Rubaba Hussain, Leandro Mena, Tina Merritt, C. Brendan Montano, Jason Morris, Meenakshi Patel, Ayesha Rashid, H. J. Solomon, Mousumi Som, George Taffet · 发表于：JAMA · 年份：2021 · DOI：10.1001/jama.2021.8828 · 被引用次数：208 · 研究领域：COVID-19 Clinical Research Studies、SARS-CoV-2 and COVID-19 Research、SARS-CoV-2 detection and testing

Importance: Preventive interventions are needed to protect residents and staff of skilled nursing and assisted living facilities from COVID-19 during outbreaks in their facilities. Bamlanivimab, a neutralizing monoclonal antibody against SARS-CoV-2, may confer rapid protection from SARS-CoV-2 infection and COVID-19. Objective: To determine the effect of bamlanivimab on the incidence of COVID-19 among residents and staff of skilled nursing and assisted living facilities. Design, Setting, and Participants: Randomized, double-blind, single-dose, phase 3 trial that enrolled residents and staff of 74 skilled nursing and assisted living facilities in the United States with at least 1 confirmed SARS-CoV-2 index case. A total of 1175 participants enrolled in the study from August 2 to November 20, 2020. Database lock was triggered on January 13, 2021, when all participants reached study day 57. Interventions: Participants were randomized to receive a single intravenous infusion of bamlanivimab, 4200 mg (n = 588), or placebo (n = 587). Main Outcomes and Measures: The primary outcome was incidence of COVID-19, defined as the detection of SARS-CoV-2 by reverse transcriptase-polymerase chain reaction and mild or worse disease severity within 21 days of detection, within 8 weeks of randomization. Key secondary outcomes included incidence of moderate or worse COVID-19 severity and incidence of SARS-CoV-2 infection. Results: The prevention population comprised a total of 966 participants (6...