Eli Lilly and Company announced that its neutralizing antibody, Bamlanivimab (LY-CoV555), significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities, according to a news release from the company.
The Phase 3 BLAZE-2 COVID-19 prevention trial – conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN) – enrolled residents and staff at skilled nursing and assisted living facilities, commonly referred to as nursing homes, across the United States.
The 965 participants who tested negative for the SARS-CoV-2 virus at baseline (299 residents and 666 staff) were included in the analysis of primary and key secondary endpoints for assessing prevention, while the 132 participants (41 residents and 91 staff) who tested positive for the virus at baseline were included in exploratory analyses for assessing treatment. All participants were randomized to receive either 4,200 mg of bamlanivimab or placebo.
After all participants reached 8 weeks of follow-up, there was a significantly lower frequency of symptomatic COVID-19 (the primary endpoint) in the bamlanivimab treatment arm versus placebo. Results for all key secondary endpoints also reached statistical significance in both the overall and resident populations.
For the pre-specified subgroup of nursing home residents, there was also a significantly lower frequency of symptomatic COVID-19 in those treated with bamlanivimab versus placebo.These results suggest that residents randomized to bamlanivimab have up to an 80 percent lower risk of contracting COVID-19 versus residents in the same facility randomized to placebo, Eli Lilly said.
Among the 299 residents in the prevention group, there were 4 deaths attributed to COVID-19 at the time of death, and all occurred in the placebo arm. There were no COVID-19 attributed deaths in the bamlanivimab arm. Among the 41 residents in the treatment group, there were 4 deaths, and all occurred in the placebo arm with none in the bamlanivimab arm. Over the entire trial, there were a total of 16 deaths reported, including deaths not related to COVID-19, and all deaths were residents (11 deaths in placebo arm and 5 in bamlanivimab arm).
Bamlanivimab is authorized for emergency use by the U.S. Food and Drug Administration for the treatment of mild to moderate COVID-19 in high-risk patients.
The study is ongoing as an open-label trial evaluating bamlanivimab alone or administered together with another antibody as a treatment for high-risk individuals (residents and staff) diagnosed with COVID-19 at long-term care facilities.
Across all treatment arms, the trial will enroll up to 5,000 participants.
