Effect of Bamlanivimab vs Placebo on Incidence of COVID-19 Among Residents and Staff of Skilled Nursing and Assisted Living Facilities: A Randomized Clinical Trial
Creators: name: Sabo, Janelle
name: McCulloh, Russell J.
name: Gomez Lorenzo, Margarita M.
name: Clement, Meredith E.
name: Ramirez, Julio A.
name: Lipson, Brad
name: Klekotka, Paul
name: Adams, Andrew C.
name: Farrior, Jennifer
name: Van Naarden, Jacob
name: Cohen, Myron S.
name: BLAZE-2 Investigators
name: Dabora, Matan C.
name: Knorr, Jack
name: Stemer, Alexander
name: Mulligan, Mark J.
name: Mayer, Stockton M.
name: Yen, Catherine
name: Novak, Richard M.
name: Thai, Christine
name: Custer, Kenneth L.
name: Shen, Lei
name: Brown, Elizabeth R.
name: Montague, Brian T.
name: Brengle, Blair
name: Wohl, David
name: Frank, Ian
name: Chege, Wairimu
name: Sista, Nirupama
name: Marovich, Mary
name: Tuttle, Jay L.
name: Gabra, Nashwa
name: Skovronsky, Daniel M.
name: Price, Karen L.
name: Fichtenbaum, Carl J.
name: Schade, Andrew E.
name: Nirula, Ajay
Publisher: name: The University of North Carolina at Chapel Hill University Libraries
Year: 2021

description: 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, 4200mg (n = 588), or placebo (n = 587). MAIN OUTCOMES AND MEASURES The primary outcomewas 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 (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 RELEVANCE Among 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.