Abstract
Treatment with monoclonal antibodies provides rapid, passive immunity and may stop COVID-19 disease progression. The study evaluated the effect of bamlanivimab (BAM) or BAM + etesevimab (ETE)/sotrovimab compared to placebo on SARS-CoV-2 viral load in patients with COVID-19. The phase2, randomized, single-dose study included patients aged between ≥ 18 and < 65years, not hospitalized at the time of randomization, and had ≥ 1 mild or moderate COVID-19 symptoms. Study included arms1-6 (placebo, BAM 175mg + ETE 350mg, BAM 700mg + ETE 1400mg, BAM 2800mg + ETE 2800mg, BAM 700mg alone, and BAM 350mg + ETE 700mg, respectively), BAM 700mg + ETE 700mg unintentional dosing; and arms7 and 8 (BAM 700mg + sotrovimab 500mg and placebo, respectively). The primary endpoint was proportion of patients with SARS-CoV-2 log viral load > 5.27 on day7 (persistently high viral load [PHVL]) who received BAM or BAM + (ETE or sotrovimab). A total of 725 patients, mean age 39.6years (range 18-75years), 50.2% male were randomized and infused with study drug in arms1-6; and a total 202 patients, mean age 38years (range 18-63years), 53.5% female were randomized and infused with study drug in arms7 and 8. A significantly lower proportion of patients in arms2-6 and arm 7 experienced PHVL on day7 compared to placebo. On day7, patients in arms2, 3, and 6 consistently experienced significantly greater reduction in viral load than placebo. Significant improvement was observed in time to viral load clearance and time to symptom improvement by day29 in some arms compared to placebo. No new safety concerns were observed with drug combinations. The study demonstrated that a significantly lower proportion of patients with mild-to-moderate COVID-19 treated with BAM or BAM + (ETE or sotrovimab) experienced a PHVL at day7. ClinicalTrials.gov identifier, NCT04634409.
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