Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): A randomized, controlled, open-label, platform trial
The Lancet — Horby PW, Mafham M, Peto L, et al. | February 14, 2022
In this study, use of casirivimab and imdevimab (monoclonal antibodies) in combination in patients hospitalized for COVID-19 led to decrease in 28-day mortality in those who were seronegative (and thus had not mounted their own humoral immune response) at baseline but not in those who were seropositive at baseline.
In this randomized, controlled, open-label platform trial (RECOVERY), patients aged at least 12 years admitted to hospital with clinically suspected or laboratory-confirmed SARS-CoV-2 infection were included.
A total of 4,839 patients were randomized to casirivimab and imdevimab plus usual care and 4946 to usual care alone.
In the primary efficacy population of seronegative patients, death within 28 days occurred of 24% of patients who received casirivimab and imdevimab vs 30% of patients allocated to usual care (rate ratio [RR] 0·79).
In an analysis of all randomly assigned patients (regardless of baseline antibody status), 19% of patients treated with casirivimab and imdevimab vs 21% of patients allocated to usual care died within 28 days (RR 0·94).
The proportional impact of casirivimab and imdevimab on death varied significantly between seropositive and seronegative patients.
No treatment related deaths occurred, and no meaningful between-group differences existed in the pre-specified safety outcomes of cause-specific mortality, cardiac arrhythmia, thrombosis, or major bleeding events.