Myron S. Cohen, Ajay Nirula, Mark J. Mulligan, et al<\/h3>\n\n\n\nJAMA. <\/em>Published online June 3, 2021. doi:10.1001\/jama.2021.8828<\/h3>\n\n\n\nAbstract<\/h2>\n\n\n\nImportance<\/strong><\/h3>\n\n\n\nPreventive 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.<\/p>\n\n\n\n
Objective<\/strong><\/h3>\n\n\n\nTo determine the effect of bamlanivimab on the incidence of COVID-19 among residents and staff of skilled nursing and assisted living facilities.<\/p>\n\n\n\n
Design, Setting, and Participants<\/strong><\/h3>\n\n\n\nRandomized, 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.<\/p>\n\n\n\n
Interventions<\/strong><\/h3>\n\n\n\nParticipants were randomized to receive a single intravenous infusion of bamlanivimab, 4200 mg (n\u2009=\u2009588), or placebo (n\u2009=\u2009587).<\/p>\n\n\n\n
Main Outcomes and Measures<\/strong><\/h3>\n\n\n\nThe primary outcome was incidence of COVID-19, defined as the detection of SARS-CoV-2 by reverse transcriptase\u2013polymerase 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.<\/p>\n\n\n\n
Results<\/strong><\/h3>\n\n\n\nThe 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<\/em>\u2009<\u2009.001; absolute risk difference, \u22126.6 [95% CI, \u221210.7 to \u22122.6] 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).<\/p>\n\n\n\n![\"\"\/](\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/938727\/m_joi210061f1_1625172038.99486.png?Expires=1629456178&Signature=0yTWkL7gGchs94Wnva17z7XKs-N8uvG0PpAaYFPIt7um3uq8a4ECeS9dcnW81ksYXdYruhMPofrDlDi9eI46EvLNPb7Jl2fJk9ojjG9fzpamb7pCV7p0cuhtGNVfU9rayMNhLs5zqUcCzL99UeVsloT61hPYTjXUxSvU3qpH0vjgkgvC2~ssX70r1collS4llOiSAZ9MQq25eXk8FQXzQeKCKI0YH354bQBQWb3rS2gOsXWMtXxAjsYihcZTBY42NUkOKTQ4qRubIeX69R~kGV54rXUNJHE03P0CN9o3FUkMlrQBKdTJiK8TsYylHIBcdvX4ahuHPKwn8hh7pruArg__&Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\")
<\/figure>\n\n\n\n![\"\"\/](\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/938727\/m_joi210061f2_1625172039.05486.png?Expires=1629456178&Signature=JIs~vZKVIqvnApjevb4H7FezRoFV79d99-UG90Svn5Gyy1DQH1CWaEO22UyU2RW76HUXIdn-EI-fTpwpNvwfrdC2dKFHMSSBFvIdRlmw9~6J-w4ctX9190QvbENkudVOUjMVzDPhDRfFBbL7pbrRnVeD8H~YlU9UmH2YYlU9yDUtWmXHEjzFE5M-Q6~~2zsl4tfyHNmaTITAKiC55p9GQC~JVswaZZ3RLDZ3YVzbdzCPiMCf2YU6TajXyqnZRi2sSKCgKFqqdm1F~wAqZNccP2XOa0aBwIrj9IkByZo2CAnRhZFYvoqiQCtL~T1pzCX-08iAgao4rG1XYjawhbPU2Q__&Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\")
<\/figure>\n\n\n\n![\"\"\/](\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/938727\/m_joi210061f3_1625172039.0749.png?Expires=1629456178&Signature=FdC3k4CWZxVvTgvI49coBhUurUUi9DpxtbwF8oxMhUGDGf8tBUrJ-uDRonTiqFVry0lPHEq3lY0mEL6e4BE~rVIfhNsDunPZIsGgBrvYRBstALrmY5RTfwWE~-PPu9K80kz5aWjGis02lwXUo4pjb5vW1SwFYE4v~PTDIsyB0POz0V7PImmYH1Unj84I5sSMn4IVT6HBLMCPLAlrXOUGhm0IRyPZQO~Ct7YQCtbzTJ9F4wwbHmbqKPjHeOE~zymQi8AYIw5Mazw0DyNhsnACFEJi~L8HwOaUqgNpX-~dH-Zj0E6mUqoX5RGIoA82ECbjo5yJ0dZ-Ftwz6PfZ6xwRbw__&Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\")
<\/figure>\n\n\n\n![\"\"\/](\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/938727\/m_joi210061t1_1625172039.02986.png?Expires=1629456178&Signature=B4AD5s1b1BkDqDz3zOzytsdd~pS3pZi4zLPTGbHhWOOoRrvw8UrfYBuU6epSIo2ZfkeS0rBQoEL6MiwPcfotphPmqz2-CtMjeSgOK9rFnUGljvBw6Ks36asnjekmVJ145W-C3pylcVKrxfGZlb1q-lPUBiBpCMEs6uoM7ao7~AaF1uKkuur6oDPTB1g0N6lZEwCfY-c6LfMxYyFcazdZ1cQifLbz5l~xk42CeFnZKQvfP5DVa5KtQeJEY-u7Yk3HHOn1ESRYXvkJ7OHcS42orznd22pNfCh-GhqRF2~WYeThmbVSOU7uF5glSQIh80Q45DkWKwEJlbE2ZkUv0DzDJw__&Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\")
<\/figure>\n\n\n\n![\"\"\/](\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/938727\/m_joi210061t2_1625172039.12492.png?Expires=1629456178&Signature=t7O3bOFbCXZ3B0yEt0pCm2fXlO40eMPty4wEQRNM9Hbnb6ka2dY8N6n4VyBxCgyexSlibeZwPU~RjC9Nyq58nDV~vKztSulusH7TfET3Qo1Eoa7ij1NIlV1ErhE7--AG5qT~LHPwUgdHjjYYxwrKaTQ5WngAbOvcAybP3oOp83pW3Gb2sJrVFcS5v6rvHukMB-mYWGscpVC99JaxWH2svBKkeBAJhYFEhO5yUmxPU4WWibnB2B5zcdwDqAGpMGDDWUfAaJlHVkbC9GpTpzo~Rct91-JL56Msxsn9UKmZaBH4yPp4bYEsMw7hZeNlt2puOi~6nMzojIK8ZxCHszQ6TA__&Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\")
<\/figure>\n\n\n\nConclusions and Relevance<\/strong><\/h3>\n\n\n\nAmong 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.<\/p>\n\n\n\n
Abstract<\/h2>\n\n\n\nImportance<\/strong><\/h3>\n\n\n\nPreventive 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.<\/p>\n\n\n\n
Objective<\/strong><\/h3>\n\n\n\nTo determine the effect of bamlanivimab on the incidence of COVID-19 among residents and staff of skilled nursing and assisted living facilities.<\/p>\n\n\n\n
Design, Setting, and Participants<\/strong><\/h3>\n\n\n\nRandomized, 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.<\/p>\n\n\n\n
Interventions<\/strong><\/h3>\n\n\n\nParticipants were randomized to receive a single intravenous infusion of bamlanivimab, 4200 mg (n\u2009=\u2009588), or placebo (n\u2009=\u2009587).<\/p>\n\n\n\n
Main Outcomes and Measures<\/strong><\/h3>\n\n\n\nThe primary outcome was incidence of COVID-19, defined as the detection of SARS-CoV-2 by reverse transcriptase\u2013polymerase 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.<\/p>\n\n\n\n
Results<\/strong><\/h3>\n\n\n\nThe 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<\/em>\u2009<\u2009.001; absolute risk difference, \u22126.6 [95% CI, \u221210.7 to \u22122.6] 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).<\/p>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\nConclusions and Relevance<\/strong><\/h3>\n\n\n\nAmong 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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Objective<\/strong><\/h3>\n\n\n\nTo determine the effect of bamlanivimab on the incidence of COVID-19 among residents and staff of skilled nursing and assisted living facilities.<\/p>\n\n\n\n
Design, Setting, and Participants<\/strong><\/h3>\n\n\n\nRandomized, 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.<\/p>\n\n\n\n
Interventions<\/strong><\/h3>\n\n\n\nParticipants were randomized to receive a single intravenous infusion of bamlanivimab, 4200 mg (n\u2009=\u2009588), or placebo (n\u2009=\u2009587).<\/p>\n\n\n\n
Main Outcomes and Measures<\/strong><\/h3>\n\n\n\nThe primary outcome was incidence of COVID-19, defined as the detection of SARS-CoV-2 by reverse transcriptase\u2013polymerase 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.<\/p>\n\n\n\n
Results<\/strong><\/h3>\n\n\n\nThe 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<\/em>\u2009<\u2009.001; absolute risk difference, \u22126.6 [95% CI, \u221210.7 to \u22122.6] 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).<\/p>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\nConclusions and Relevance<\/strong><\/h3>\n\n\n\nAmong 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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Interventions<\/strong><\/h3>\n\n\n\nParticipants were randomized to receive a single intravenous infusion of bamlanivimab, 4200 mg (n\u2009=\u2009588), or placebo (n\u2009=\u2009587).<\/p>\n\n\n\n
Main Outcomes and Measures<\/strong><\/h3>\n\n\n\nThe primary outcome was incidence of COVID-19, defined as the detection of SARS-CoV-2 by reverse transcriptase\u2013polymerase 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.<\/p>\n\n\n\n
Results<\/strong><\/h3>\n\n\n\nThe 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<\/em>\u2009<\u2009.001; absolute risk difference, \u22126.6 [95% CI, \u221210.7 to \u22122.6] 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).<\/p>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\nConclusions and Relevance<\/strong><\/h3>\n\n\n\nAmong 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.<\/p>\n\n\n\n
The primary outcome was incidence of COVID-19, defined as the detection of SARS-CoV-2 by reverse transcriptase\u2013polymerase 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.<\/p>\n\n\n\n
Results<\/strong><\/h3>\n\n\n\nThe 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<\/em>\u2009<\u2009.001; absolute risk difference, \u22126.6 [95% CI, \u221210.7 to \u22122.6] 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).<\/p>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\nConclusions and Relevance<\/strong><\/h3>\n\n\n\nAmong 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.<\/p>\n\n\n\n
<\/figure>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\n<\/figure>\n\n\n\n