• Myron S Cohen, Ajay Nirula, Mark J Mulligan, Richard M Novak, Mary Marovich, Catherine Yen, Alexander Stemer, Stockton M Mayer, David Wohl, Blair Brengle, Brian T Montague, Ian Frank, Russell J McCulloh, Carl J Fichtenbaum, Brad Lipson, Nashwa Gabra, Julio A Ramirez, 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 L Price, Janelle Sabo, Jay L Tuttle, Paul Klekotka, Lei Shen, Daniel M Skovronsky, and BLAZE-2 Investigators.
• Institute of Global Health and Infectious Diseases, University of North Carolina at Chapel Hill.
• JAMA. 2021 Jul 6; 326 (1): 46-55.

ImportancePreventive 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.ObjectiveTo 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 ParticipantsRandomized, 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.InterventionsParticipants were randomized to receive a single intravenous infusion of bamlanivimab, 4200 mg (n = 588), or placebo (n = 587).Main Outcomes And MeasuresThe 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.ResultsThe prevention population comprised a total of 966 participants (666 staff and 300 residents) who were negative at baseline for SARS-CoV-2 infection and serology (mean age, 53.0 [range, 18-104] years; 722 [74.7%] women). Bamlanivimab significantly reduced the incidence of COVID-19 in the prevention population compared with placebo (8.5% vs 15.2%; odds ratio, 0.43 [95% CI, 0.28-0.68]; P < .001; absolute risk difference, -6.6 [95% CI, -10.7 to -2.6] percentage points). Five deaths attributed to COVID-19 were reported by day 57; all occurred in the placebo group. Among 1175 participants who received study product (safety population), the rate of participants with adverse events was 20.1% in the bamlanivimab group and 18.9% in the placebo group. The most common adverse events were urinary tract infection (reported by 12 participants [2%] who received bamlanivimab and 14 [2.4%] who received placebo) and hypertension (reported by 7 participants [1.2%] who received bamlanivimab and 10 [1.7%] who received placebo).Conclusions And RelevanceAmong residents and staff in skilled nursing and assisted living facilities, treatment during August-November 2020 with bamlanivimab monotherapy reduced the incidence of COVID-19 infection. Further research is needed to assess preventive efficacy with current patterns of viral strains with combination monoclonal antibody therapy.Trial RegistrationClinicalTrials.gov Identifier: NCT04497987.

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