Infectious Disease

Antibody cocktail lowers the risk of death and hospitalization from COVID-19

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Skovronsky is an employee of Eli Lilly and Company. Please refer to the study for all relevant financial information from the other authors.

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The monoclonal antibody cocktail of bamlanivimab plus etesevimab reduced the risk of COVID-19-related deaths and hospitalizations in high-risk outpatients compared to placebo, according to the results of the phase 3 study published today.

The cocktail made by Eli Lilly also reduced SARS-CoV-2 viral loads in the patients in the study, researchers reported in the New England Journal of Medicine.

In February, the FDA approved the emergency antibody cocktail for the treatment of patients with mild to moderate COVID-19 who are 12 years of age or older and weigh at least 88 pounds. The therapy is one of several neutralizing antibody treatments recommended by the Infectious Diseases Society of America for outpatients with COVID-19 who are at high risk of progression to serious illness.

For studying, Daniel M. Skovrosnky, MD, PhD, Senior Vice President and Chief Scientific and Medical Officer of Eli Lilly and colleagues randomly assigned 1,035 outpatients with moderate or mild COVID-19 at high risk of progression to severe disease to either an IV infusion of 2,800 mg bamlanivimab and 2,800 mg of bamlanivimab received estesevimab or a placebo within a 3-day window of 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 mean patient age was 53.8 years and 52% of the participants were women or adolescent girls. According to Skovronsky and colleagues, on day 29 of the analysis, 11 of the 518 patients (2.1%) who received the antibody cocktail died of COVID-19 or were hospitalized, while 36 of the 517 patients (7%) in (the Placebo arm died or was hospitalized, a risk difference of –4.8 percentage points (95% CI, –7.4 to –2.3; RR difference = 70%; p <0.001).

A total of 10 deaths – nine of them related to COVID-19 – occurred in the placebo group compared to none in the antibody cocktail group.

In addition, the researchers observed greater reductions in viral load in patients in the antibody treatment arm than in those who received placebo (-1.2; 95% CI, -1.46 to -0.94; P <0.001).

“These results support the potential of neutralizing monoclonal antibody therapy to reduce both the risk of progression to severe disease and the severity of disease in high-risk patients with symptomatic COVID-19,” wrote Skovronsky and colleagues.

References:

Dougan M. et al. N Engl J Med. 2021; doi: 10.1056 / NEJMoa2102685.

IDSA. IDSA guidelines for the treatment and management of patients with COVID-19. https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/. Retrieved July 14, 2021.

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