Eli Lilly and Company on Jan. 21 said its neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 infections at nursing homes in its latest trial, called the BLAZE-2 trial, reducing risk by up to 80 percent for residents.

In a statement, the company said Bamlanivimab significantly cut the risk of contracting symptomatic COVID-19 among residents and staff of long term care facilities. The antibody treatment is not a vaccine for COVID-19, but a treatment.

“The Phase 3 BLAZE-2 COVID-19 prevention trial—conducted in partnership with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the COVID-19 Prevention Network—enrolled residents and staff at skilled nursing and assisted living facilities,” Eli Lilly said.

In total, 965 participants tested negative for the SARS-CoV-2 virus at baseline (299 residents and 666 staff), while132 participants (41 residents and 91 staff) tested positive for the virus, adding to the growing body of evidence for treatment with bamlanivimab, the company said.
All participants were randomized to receive either 4,200 mg of bamlanivimab or placebo.

After all participants reached eight weeks of follow-up, there was a significantly lower frequency of symptomatic COVID-19 (the primary endpoint) in the bamlanivimab treatment arm versus placebo.

In addition, Eli Lilly said for the prespecified subgroup of just nursing home residents (no staff), 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,” the company said.

Results from exploratory analyses of viral load in the treatment group were consistent with previously disclosed data from BLAZE-1 evaluating bamlanivimab as an outpatient treatment for recently diagnosed COVID-19.

Eli Lilly said among the 299 residents in the prevention group, there were four deaths attributed to COVID-19, and all occurred in the placebo arm. There were no COVID-19 attributed deaths 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 five in bamlanivimab arm).

“We are exceptionally pleased with these positive results, which showed bamlanivimab was able to help prevent COVID-19, substantially reducing symptomatic disease among nursing home residents, some of the most vulnerable members of our society,” said Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer and president of Lilly Research Laboratories.

“These data provide important additional clinical evidence regarding the use of bamlanivimab to fight COVID-19 and strengthen our conviction that monoclonal antibodies such as bamlanivimab can play a critical role in turning the tide of this pandemic.”

An independent data and safety monitoring board oversaw the BLAZE-2 trial. In the trial, the safety profile of bamlanivimab was consistent with observations from the Phase 1 and Phase 2 trials. Serious adverse events were reported at a similar frequency in the bamlanivimab and placebo groups.

Across multiple clinical trials, Lilly now has collected safety and efficacy data in more than 4,000 patients treated with bamlanivimab, either alone or administered together with another antibody.

Bamlanivimab is authorized for emergency use by the Food and Drug Administration for the treatment of mild to moderate COVID-19 in high-risk patients. Visit combatcovid.hhs.gov to find out more about antibody therapy.