Positive results were announced from a phase 3 trial evaluating bamlanivimab (LY-CoV555; Lilly), a potent neutralizing IgG1 monoclonal antibody, for the prevention of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19) in residents and staff of long-term care facilities.

The randomized, double-blind, placebo-controlled BLAZE-2 trial included 965 adults who tested negative for SARS-CoV-2 at baseline (299 residents and 666 staff) in the primary analysis for assessing prevention; 132 adults (41 residents and 91 staff) who tested positive at baseline were included in the exploratory analyses for assessing treatment. Study participants were randomized to receive bamlanivimab 4200mg or placebo as a single intravenous infusion.

Findings showed a significantly lower frequency of symptomatic COVID-19 among individuals who received bamlanivimab compared with those who received placebo (odds ratio 0.43; P =.00021). Among nursing home residents, a significantly lower frequency of symptomatic COVID-19 was observed in the bamlanivimab arm compared with placebo (odds ratio 0.20; P =.00026). Exploratory analyses of bamlanivimab for the treatment of COVID-19 were consistent with previously reported data from the BLAZE-1 trial. 

As for safety, there were no COVID-19 attributed deaths in the bamlanivimab arm among all residents in the prevention and treatment groups compared with a total of 8 COVID-19 attributed deaths in the placebo arm. The frequency of serious adverse events was similar between bamlanivimab and placebo.


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“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. “We’re glad bamlanivimab is already available as a treatment for patients at high risk for progressing to severe COVID-19 illness or hospitalization, including those in nursing homes, and look forward to working with regulators to explore expanding the emergency use authorization to prevent the spread of COVID-19 in these facilities.”

Reference

Lilly’s neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents. [press release]. Indianapolis, IN: Eli Lilly and Company; January 21, 2021.