Why carry out this study?

It remains uncertain how in vitro antibody neutralization activity translates to clinical effectiveness for sotrovimab, a dual-action monoclonal antibody against SARS-CoV-2, for high-risk outpatients with mild-to-moderate COVID-19.

We conducted a retrospective observational cohort study of patients diagnosed with COVID-19 between 1 September 2021 and 30 April 2022 to evaluate the real-world clinical effectiveness of sotrovimab when the prevalence of circulating SARS-CoV-2 variants changed between Delta and Omicron in the USA.

What was learned from the study?

Compared with no mAb treatment, sotrovimab was associated with reduced risk of 30-day hospitalization and/or facility-reported mortality among high-risk COVID-19 patients.

Sotrovimab demonstrated real-world clinical effectiveness beyond clinical trial data, including benefits among populations not previously studied in clinical trials such as immunocompromised, those with ≥ 1 documented COVID-19 vaccine, and pregnant women.