A Phase 3 clinical trial of an antibody-drug that enrolled residents and staff at skilled nursing and assisted living facilities found that the treatment significantly reduced the risk of contracting symptomatic COVID-19.
The antibody-drug, bamlanivimab (LY-CoV555), was developed by pharmaceutical giant Eli Lilly and Company (NYSE: LLY) for clinical use with the Vancouver-based biotech firm AbCellera, with multiple long-term care facilities participating in the trial. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN) partnered with Lilly on the trial.
“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,” Lilly said in a January 21 press release.
The Phase 3 BLAZE-2 COVID-19 prevention trial included 965 participants at baseline who tested negative for COVID-19 and 132 participants who were COVID-19 positive at baseline. All of the trial’s participants were randomized to receive either a placebo or 4,200 mg of LY-CoV555.
A pre-specified subgroup of nursing home residents treated with LY-CoV555 had “a significantly lower frequency of COVID-19,” compared with those who received the placebo, according to Lilly.
Specifically, this included an odds ratio — “the odds that an outcome will occur given a particular exposure, compared to the odds of the outcome occurring in the absence of that exposure,” according to the Journal of the Canadian Academy of Child and Adolescent Psychiatry — of 0.20, according to Lilly’s press release.
According to the Lilly release, “these results suggest 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.”
To conduct the trial among nursing home residents, Lilly’s research partner Care Access Research helped bring the clinic sites to nursing homes, with teams dispatched to participating facilities to conduct the trials — a process that included setting up retrofitted recreational vehicles to prepare the antibody and providing infusions inside the facility itself, Care Access Research told Skilled Nursing News in October 2020.
“Traditionally, research is not an option for these populations, and a lot of time, they’re forgotten,” Care Access Research CEO Ahmad Namvargolian told SNN at the time.
To be eligible, there had to be at least one confirmed COVID-19 case among residents or staff at the SNFs and assisted living facilities, based on a collection of samples no more than a week before randomization. The residents and the staff were tested weekly for COVID-19 regardless of symptoms.
The study itself is ongoing and evaluating LY-CoV555 either alone or with another antibody as a treatment for high-risk individuals diagnosed with COVID-19; the trial is expected to enroll up to 5,000 participants across all treatment arms.
