October 28, 2020 | Peter Chen, M.D., Ajay Nirula, M.D., Ph.D., Barry Heller, M.D., Robert L. Gottlieb, M.D., Ph.D., Joseph Boscia, M.D., Jason Morris, M.D., Gregory Huhn, M.D., M.P.H.T.M., Jose Cardona, M.D., Bharat Mocherla, M.D., Valentina Stosor, M.D., Irmad Shawa, M.D., Andrew C. Adams, Ph.D., Jacob Van Naarden, B.S., Kenneth L. Custer, Ph.D., Lei Shen, Ph.D., Michael Durante, M.S., Gerard Oakley, M.D., Andrew E. Schade, M.D., Ph.D., Janelle Sabo, Pharm.D., Dipak R. Patel, M.D., Ph.D., Paul Klekotka, M.D., Ph.D., and Daniel M. Skovronsky, M.D., Ph.D., for the BLAZE-1 Investigators*
This study evaluates the efficacy and safety of LY-CoV555, a neutralizing monoclonal antibody, in treating mild or moderate Covid-19 in outpatients. The BLAZE-1 trial randomly assigned 452 patients to receive either LY-CoV555 at one of three doses (700 mg, 2800 mg, or 7000 mg) or a placebo. The primary outcome was the change in viral load from baseline at day 11. The results showed that the mean decrease in log viral load for the entire population was -3.81, eliminating more than 99.97% of viral RNA. The 2800 mg dose of LY-CoV555 significantly reduced viral load compared to placebo, while the 700 mg and 7000 mg doses showed smaller or no significant differences. Patients receiving LY-CoV555 had slightly less severe symptoms and a lower rate of hospitalization or emergency department visits compared to the placebo group. The safety profile of LY-CoV555 was similar to that of placebo, with no serious adverse events reported. The study suggests that LY-CoV555 may be effective in reducing viral load and improving symptoms in patients with mild or moderate Covid-19.This study evaluates the efficacy and safety of LY-CoV555, a neutralizing monoclonal antibody, in treating mild or moderate Covid-19 in outpatients. The BLAZE-1 trial randomly assigned 452 patients to receive either LY-CoV555 at one of three doses (700 mg, 2800 mg, or 7000 mg) or a placebo. The primary outcome was the change in viral load from baseline at day 11. The results showed that the mean decrease in log viral load for the entire population was -3.81, eliminating more than 99.97% of viral RNA. The 2800 mg dose of LY-CoV555 significantly reduced viral load compared to placebo, while the 700 mg and 7000 mg doses showed smaller or no significant differences. Patients receiving LY-CoV555 had slightly less severe symptoms and a lower rate of hospitalization or emergency department visits compared to the placebo group. The safety profile of LY-CoV555 was similar to that of placebo, with no serious adverse events reported. The study suggests that LY-CoV555 may be effective in reducing viral load and improving symptoms in patients with mild or moderate Covid-19.