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An effective intervention based on passive immunity would be a useful tool to curb the morbidity and mortality of the COVID-19 pandemic. To investigate the safety and efficacy of the monoclonal antibody combination bamlanivimab plus etesevimab, investigators randomized patients with mild to moderate COVID-19 (and excess risk for disease progression) to receive these antibodies or placebo in a manufacturer-funded study. Patients were followed for 29 days to assess the primary outcome of COVID-19 hospitalization or death from any cause.
By January of 2021, 1035 ambulatory patients were randomized 1:1 to bamlanivimab plus etesevimab or placebo (mean age, 53; 52% female; median body-mass index, 34; 95% at high risk for severe COVID-19). Hospitalization or death of any cause were significantly less common in the antibody group than the placebo group (2.1% vs. 7%). By day 7, the reduction in SARS-CoV-2 viral load in the antibody group was 16 times that in the placebo group. Median time to resolution of symptoms was shorter by 1 day in the antibody group (8 vs. 9 days). The frequency of serious adverse events was comparable in the antibody group and placebo group (1.4% and 1.0%, respectively).
Dougan M et al. Bamlanivimab plus etesevimab in mild or moderate Covid-19. N Engl J Med 2021 Jul 14; [e-pub]. (https://doi.org/10.1056/NEJMoa2102685)
Comment
The advent and global dissemination of SARS-CoV-2 variants of concern eliminated the clinical benefit of this antibody combination. However, this well-designed study provides proof of concept that monoclonal antibodies can improve clinical outcomes of COVID-19 in outpatients at risk for disease progression. Other antibody combinations are currently being evaluated.