Lilly’s Bamlanivimab Cuts Risk of COVID-19 By Up to 80% at Nursing Homes

Eli Lilly announced Thursday that in a phase 3 study, bamlanivimab was shown to significantly reduce the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities. The findings from the BLAZE-2 COVID-19 prevention trial suggest the risk was decreased by up to 80% in people administered the antibody therapy versus those in the same facility given placebo.

The study enrolled residents and staff at skilled nursing and assisted living facilities across the US, with 965 people who tested negative for the SARS-CoV-2 virus at baseline randomized to receive either bamlanivimab or placebo. The trial’s primary outcome measure is cumulative incidence of COVID-19, defined as the detection of SARS-CoV-2 by RT-PCR and mild or worse disease severity within 21 days of detection. Meanwhile, additional endpoints include cumulative incidence of SARS-CoV-2 infection and moderate or worse disease severity within 21 days of detection.

Risk lower in both residents, staff

According to Eli Lilly, participants who tested negative for SARS-CoV-2 at baseline, including 299 residents and 666 staff, were included in the analysis of primary and key secondary endpoints for assessing prevention, while 132 people, comprising 41 residents and 91 staff, who tested positive for the virus at baseline, were included in exploratory analyses for assessing treatment.

Results demonstrated that after all participants reached 8 weeks of follow-up, there was a significantly lower frequency of symptomatic COVID-19 in the bamlanivimab treatment arm versus placebo, while this was also seen in the prespecified subgroup of nursing home residents. The company added that all key secondary endpoints reached significance in both the overall and resident populations. Further, exploratory analyses showed that results for viral load in the treatment group were “consistent” with previously disclosed data from the BLAZE-1 study evaluating bamlanivimab as an outpatient treatment for recently diagnosed COVID-19.

No COVID-19-related deaths in bamlanivimab arm

Eli Lilly indicated that among the 299 residents in the prevention group, there were four deaths attributed to COVID-19, and all occurred in the placebo arm. Meanwhile, among the 41 residents in the treatment group, there were four deaths, all of which occurred in the placebo arm as well. Over the entire trial, there were a total of 16 reported deaths reported, including those not related to COVID-19. The drugmaker said that all of these deaths were in residents, with 11 in the placebo arm and five in the bamlanivimab arm.

Daniel Skovronsky, president of Lilly Research Laboratories, remarked “these data provide important additional clinical evidence regarding the use of bamlanivimab to fight COVID-19,” adding that the company will work “with regulators to explore expanding the emergency-use authorisation to prevent the spread of COVID-19 in these facilities.” Bamlanivimab is currently authorized for emergency use in the US for the treatment of mild-to-moderate COVID-19 in high-risk patients. The drug, also known as LY-CoV555, is a recombinant, neutralising human IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2.