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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.
JAMA. 2021 07 06; 326(1):46-55.JAMA

Abstract

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 (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.

Trial Registration

ClinicalTrials.gov Identifier: NCT04497987.

Authors+Show Affiliations

Institute of Global Health and Infectious Diseases, University of North Carolina at Chapel Hill.Eli Lilly and Co, Indianapolis, Indiana.New York University Langone Vaccine Center, Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York.University of Illinois College of Medicine, Chicago.Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland.Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland.Indiana University School of Medicine, Gary.University of Illinois College of Medicine, Chicago.Institute of Global Health and Infectious Diseases, University of North Carolina at Chapel Hill.Brengle Family Medicine, Indianapolis, Indiana.Division of Infectious Diseases, University of Colorado School of Medicine, Aurora.Division of Infectious Diseases, University of Pennsylvania Perelman School of Medicine, Philadelphia.University of Nebraska Medical Center, Omaha.University of Cincinnati Academic Health Center, Cincinnati, Ohio.Florida Primary and Specialty Care, Boca Raton.Burke Internal Medicine & Research, Burke, Virginia.Division of Infectious Diseases, University of Louisville School of Medicine, Louisville, Kentucky.private practice, Huntington Beach, California.Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland.Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland.FHI 360, Durham, North Carolina.FHI 360, Durham, North Carolina.Louisiana State University Health Sciences Center, New Orleans.Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.Eli Lilly and Co, Indianapolis, Indiana.Eli Lilly and Co, Indianapolis, Indiana.Eli Lilly and Co, Indianapolis, Indiana.Eli Lilly and Co, Indianapolis, Indiana.Eli Lilly and Co, Indianapolis, Indiana.Eli Lilly and Co, Indianapolis, Indiana.Eli Lilly and Co, Indianapolis, Indiana.Eli Lilly and Co, Indianapolis, Indiana.Eli Lilly and Co, Indianapolis, Indiana.Eli Lilly and Co, Indianapolis, Indiana.Eli Lilly and Co, Indianapolis, Indiana.Eli Lilly and Co, Indianapolis, Indiana.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

34081073

Citation

Cohen, Myron S., et al. "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." JAMA, vol. 326, no. 1, 2021, pp. 46-55.
Cohen MS, Nirula A, Mulligan MJ, et al. 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. JAMA. 2021;326(1):46-55.
Cohen, M. S., Nirula, A., Mulligan, M. J., Novak, R. M., Marovich, M., Yen, C., Stemer, A., Mayer, S. M., Wohl, D., Brengle, B., Montague, B. T., Frank, I., McCulloh, R. J., Fichtenbaum, C. J., Lipson, B., Gabra, N., Ramirez, J. A., Thai, C., Chege, W., ... Skovronsky, D. M. (2021). 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. JAMA, 326(1), 46-55. https://doi.org/10.1001/jama.2021.8828
Cohen MS, et al. 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. JAMA. 2021 07 6;326(1):46-55. PubMed PMID: 34081073.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Cohen,Myron S, AU - Nirula,Ajay, AU - Mulligan,Mark J, AU - Novak,Richard M, AU - Marovich,Mary, AU - Yen,Catherine, AU - Stemer,Alexander, AU - Mayer,Stockton M, AU - Wohl,David, AU - Brengle,Blair, AU - Montague,Brian T, AU - Frank,Ian, AU - McCulloh,Russell J, AU - Fichtenbaum,Carl J, AU - Lipson,Brad, AU - Gabra,Nashwa, AU - Ramirez,Julio A, AU - Thai,Christine, AU - Chege,Wairimu, AU - Gomez Lorenzo,Margarita M, AU - Sista,Nirupama, AU - Farrior,Jennifer, AU - Clement,Meredith E, AU - Brown,Elizabeth R, AU - Custer,Kenneth L, AU - Van Naarden,Jacob, AU - Adams,Andrew C, AU - Schade,Andrew E, AU - Dabora,Matan C, AU - Knorr,Jack, AU - Price,Karen L, AU - Sabo,Janelle, AU - Tuttle,Jay L, AU - Klekotka,Paul, AU - Shen,Lei, AU - Skovronsky,Daniel M, AU - ,, PY - 2021/6/4/pubmed PY - 2021/7/13/medline PY - 2021/6/3/entrez SP - 46 EP - 55 JF - JAMA JO - JAMA VL - 326 IS - 1 N2 - 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 (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. Trial Registration: ClinicalTrials.gov Identifier: NCT04497987. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/34081073/full_citation L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2021.8828 DB - PRIME DP - Unbound Medicine ER -