SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19

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研究概要

Four hundred and fifty two patients who tested positive for coronavirus disease 19 (COVID19) were randomized to receive a single intravenous infusion of LY-CoV555, at a dose of 700mg, 2800mg, or 7000mg, or placebo, for the reduction of viral load and amelioration of symptoms. The primary outcome of interest was the change from baseline in viral load at 11 days follow up. Secondary outcomes of interest included the change in symptoms, incidence of adverse events, and hospitalization rates. Viral load was measured at 3, 7 and 11 days follow up, whilst secondary outcomes were measured up to 29 days follow up. With the exception of the change in viral load from baseline at days 3 and 11 in the 2800mg, which was statistically significantly greater compared to placebo, no statistically significant differences the change in viral load from baseline were observed between the LY-CoV555 groups and placebo at all three time-points. The rate of hospitalization was 1.6% in the pooled LY-CoV555 group, compared to 6.3% in the placebo group. The incidence of adverse events was similar between the two groups (22.3% vs. 24.5%). The change in symptoms scores from baseline was statistically significantly greater in the pooed LY-CoV555 group compared to the placebo group between days 2-6.