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
Open accessAbstract
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.
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Convalescent plasma or recombinant therapeutic S protein-targeted antibodies achieved modest or mixed results in preventing severe COVID-19.
“Consistent with this view, convalescent plasma or recombinant therapeutic S protein-targeted antibodies achieved modest or mixed results in preventing severe COVID-19 (however, the emergence of SARS-CoV-2 VOC with mutations in the spike protein that may allow the evasion of neutralizing antibodies may further complicate the interpretation of these results) (refs.65,162,167).”
From COVID-19 and cellular senescence (2023) · cites this paper as [167]
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- Authors
- 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., Gomez Lorenzo, M. M., Sista, N., Farrior, J., Clement, M. E., Brown, E. R., Custer, K. L., Van Naarden, J., Adams, A. C., Schade, A. E., Dabora, M. C., Knorr, J., Price, K. L., Sabo, J., Tuttle, J. L., Klekotka, P., Shen, L., Skovronsky, D. M., BLAZE-2 Investigators, Gyamfi, K.-A., Begue, J., Borgetti, S., Burkholder, G., Edupuganti, S., Gannon, K., Hall, C., Horstman, V., Hussain, R., Mena, L., Merritt, T., Montano, C., Morris, J., Patel, M., Rashid, A., Solomon, H., Som, M., & Taffet, G.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- Eli Lilly (United States) (US)
- New York University (US)
- University of Illinois College of Medicine, Chicago
- National Institutes of Health (US)
- Indiana University School of Medicine (US)
- University of Illinois Chicago (US)
- Indianapolis Public Library (US)
- University of Colorado Anschutz (US)
- University of Pennsylvania (US)
- University of Nebraska Medical Center (US)
- University of Cincinnati Medical Center (US)
- 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
- Family Health International 360 (US)
- Louisiana State University Health Sciences Center New Orleans (US)
- Fred Hutch Cancer Center (US)
- Eli Lilly and Co, Indianapolis, Indiana
- for the BLAZE-2 Investigators
- Corresponding author
- Skovronsky, Daniel M.
- ORCID
- Cohen, Myron S.
- Mulligan, Mark J.
- Marovich, Mary
- Mayer, Stockton M.
- Wohl, David
- Montague, Brian T.
- Frank, Ian
- McCulloh, Russell J.
- Fichtenbaum, Carl J.
- Lipson, Brad
- Thai, Christine
- Chege, Wairimu
- Clement, Meredith E.
- Brown, Elizabeth R.
- Adams, Andrew C.
- Tuttle, Jay L.
- Borgetti, Scott
- Burkholder, Greer
- Edupuganti, Srilatha
- Mena, Leandro
- Patel, Meenakshi
- Som, Mousumi
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2021-07-06
- Volume
- 326
- Issue
- 1
- Pages
- 46
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC8176388
- OpenAlex
- W3164832774
- Cited by
- 193
- References
- 24
- Citations by year
- 2025: 12 · 2024: 14 · 2023: 43 · 2022: 81 · 2021: 43
- FWCI
- 14.32
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Purdue University Indianapolis (Indiana University) (submittedVersion)
- IUScholarWorks (Indiana University) (submittedVersion)
- Funders
- National Institute of Allergy and Infectious Diseases (U01AI047996, U01AI068635, U01AI068614, UM1AI068619, UM1AI069534, UM1AI068614, UM1AI068635, UM1AI148574, P30AI045008, UM1AI148684, UM1AI068617, UM1AI069412)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Health Sciences › Health Professions › General Health Professions › Geriatric Care and Nursing Homes
- Keywords
- bamlanivimab, COVID-19 prevention, SARS-CoV-2, skilled nursing facilities, assisted living, neutralizing monoclonal antibodies, COVID-19 incidence, disease severity, outbreak prevention, post-exposure prophylaxis, SARS-CoV-2 serology, COVID-19 mortality
- MeSH terms
- COVID-19, SARS-CoV-2, Adolescent, Adult, Aged, Aged, 80 and over, Antiviral Agents, Double-Blind Method, Female, Health Personnel, Humans, Immunization, Passive, Infusions, Intravenous, Male, Middle Aged, Severity of Illness Index, Skilled Nursing Facilities, Incidence, Drug Approval, Assisted Living Facilities, Young Adult, Antibodies, Neutralizing, Antibodies, Monoclonal, Humanized
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