Antibody cocktail lowers risk for death, hospitalization from COVID-19
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The monoclonal antibody cocktail of bamlanivimab plus etesevimab reduced the risk for COVID-19-related death and hospitalization among high-risk ambulatory patients compared with placebo, according to phase 3 trial results published today.
The cocktail, which is manufactured by Eli Lilly, also reduced SARS-CoV-2 viral load among the patients in the trial, researchers reported in The New England Journal of Medicine.
In February, the FDA authorized the antibody cocktail for emergency use to treat patients with mild to moderate COVID-19 who are aged 12 years or older and weight at least 88 pounds. The therapy is one of several neutralizing antibody treatments suggested for use by the Infectious Diseases Society of America for ambulatory patients with COVID-19 who are at high risk for progression to severe disease.
For the study, Daniel M. Skovrosnky, MD, PhD, senior vice president and chief scientific and medical officer for Eli Lilly, and colleagues randomly assigned 1,035 ambulatory patients with moderate or mild COVID-19 at high risk for progression to severe disease to receive either one IV infusion of 2,800 mg of bamlanivimab and 2,800 mg of estesevimab or a placebo within a 3-day window after diagnosis with SARS-CoV-2.
The primary outcome of the study was the overall clinical status of each patient, which the researchers defined as COVID-19-related death or hospitalization from any cause by day 29.
The average patient age was 53.8 years, and 52% of the participants were women or adolescent girls. According to Skovronsky and colleagues, at day 29 of the analysis, 11 of the 518 patients (2.1%) who received the antibody cocktail died or were hospitalized as a result of COVID-19, whereas 36 of the 517 patients (7%) in the placebo arm died or were hospitalized, a risk difference of –4.8 percentage points (95% CI, –7.4 to –2.3; RR difference = 70%; P < .001).
A total of 10 deaths — nine of which were related to COVID-19 — occurred in the placebo group compared with none in the antibody cocktail group.
Additionally, the researchers observed a higher reduction in viral load among patients in the antibody treatment arm than those who received placebo (–1.2; 95% CI, –1.46 to –0.94; P < .001).
“These results provide support for the potential of neutralizing monoclonal-antibody therapy to reduce both the risk of progression to severe disease and the severity of disease among high-risk patients with symptomatic COVID-19,” Skovronsky and colleagues wrote.
References:
Dougan M, et al. N Engl J Med. 2021;doi:10.1056/NEJMoa2102685.
IDSA. IDSA guidelines on the treatment and management of patients with COVID-19. https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/. Accessed July 14, 2021.
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