Sotrovimab reduces the likelihood of hospitalization in at-risk outpatients with mild to moderate COVID-19 (NNT = 16)

Reference

Gupta A, Gonzalez-Rojas Y, Juarez E, et al, for the COMET-ICE Investigators. Early treatment for Covid-19 with SARS-CoV-2 neutralizing antibody sotrovimab. N Engl J Med 2021;385(21):1941-1950.

Synopsis

Sotrovimab is a monoclonal antibody against an epitope of sarbecoviruses (including SARS-CoV-1 and SARS-CoV-2) that appears to mutate infrequently since it is not involved in binding to receptors on human cells. These researchers identified adults with a positive test result for SARS-CoV-2 in the previous 5 days who also had at least one of the following risk factors for disease progression: 55 years or older, diabetes, obesity, chronic kidney disease, heart failure, chronic obstructive pulmonary disease, or moderate to severe asthma. All were being treated as outpatients for mild to moderate disease, with a mean age of 53 years, and a body mass index of 32. A total of 58% were recruited within 3 days and the most common risk factors were age, obesity, and diabetes. Most patients had only a single risk factors, and only 11% had 3 or more. Groups were balanced at baseline and analysis was by intention to treat (ITT). The trial was stopped after 1057 patients had been randomized to receive a single infusion of 500 mg sotrovimab or placebo; the 583 who had sufficient follow-up constituted the ITT population. The primary outcome of death or hospitalization for more than 1 day occurred significantly less often in the sotrovimab group (1.0% vs 7.2%; relative risk 0.15; 97.24% CI 0.04 - 0.56; number needed to treat [NNT] = 16). There was only one death, which occurred in the placebo group, and all but one of the hospitalizations were thought to be COVID-related. Patients in the sotrovimab group also had numerically fewer emergency department visits or short-term hospital stays (3 vs 7). All 5 patients who required mechanical ventilation or admission to the intensive care unit were in the placebo group. Serious adverse events were rare and less common in the treatment group.