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., Imad 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 reports the results of an ongoing phase 2 trial (BLAZE-1) evaluating the efficacy and safety of the neutralizing antibody LY-CoV555 in patients with mild or moderate Covid-19. The trial involved 452 patients who received a single intravenous infusion of LY-CoV555 at three doses (700 mg, 2800 mg, or 7000 mg) or placebo. The primary outcome was the change in viral load at day 11, with a mean decrease of -3.81 in the log viral load for the entire population, indicating a reduction of over 99.97% of viral RNA. For patients receiving the 2800-mg dose, the decrease from baseline was -0.53 (95% CI, -0.98 to -0.08; P=0.02), corresponding to a lower viral load by a factor of 3.4 compared to placebo. Smaller differences were observed for the 700-mg and 7000-mg doses. Patients receiving LY-CoV555 had slightly lower symptom severity than those receiving placebo. The percentage of patients who had a Covid-19-related hospitalization or emergency department visit was 1.6% in the LY-CoV555 group and 6.3% in the placebo group.
The study found that the 2800-mg dose of LY-CoV555 appeared to accelerate the natural decline in viral load over time, while the other doses did not by day 11. The safety profile of LY-CoV555 was similar to that of placebo, with no serious adverse events reported in the LY-CoV555 group and only 0.7% in the placebo group. The results suggest that LY-CoV555 may be a useful treatment for emergency use in patients with recently diagnosed Covid-19. The study was funded by Eli Lilly and was conducted in accordance with the Declaration of Helsinki and ethical guidelines. The findings indicate that LY-CoV555 could reduce the rate of hospitalization and symptom severity in patients with mild or moderate Covid-19.This study reports the results of an ongoing phase 2 trial (BLAZE-1) evaluating the efficacy and safety of the neutralizing antibody LY-CoV555 in patients with mild or moderate Covid-19. The trial involved 452 patients who received a single intravenous infusion of LY-CoV555 at three doses (700 mg, 2800 mg, or 7000 mg) or placebo. The primary outcome was the change in viral load at day 11, with a mean decrease of -3.81 in the log viral load for the entire population, indicating a reduction of over 99.97% of viral RNA. For patients receiving the 2800-mg dose, the decrease from baseline was -0.53 (95% CI, -0.98 to -0.08; P=0.02), corresponding to a lower viral load by a factor of 3.4 compared to placebo. Smaller differences were observed for the 700-mg and 7000-mg doses. Patients receiving LY-CoV555 had slightly lower symptom severity than those receiving placebo. The percentage of patients who had a Covid-19-related hospitalization or emergency department visit was 1.6% in the LY-CoV555 group and 6.3% in the placebo group.
The study found that the 2800-mg dose of LY-CoV555 appeared to accelerate the natural decline in viral load over time, while the other doses did not by day 11. The safety profile of LY-CoV555 was similar to that of placebo, with no serious adverse events reported in the LY-CoV555 group and only 0.7% in the placebo group. The results suggest that LY-CoV555 may be a useful treatment for emergency use in patients with recently diagnosed Covid-19. The study was funded by Eli Lilly and was conducted in accordance with the Declaration of Helsinki and ethical guidelines. The findings indicate that LY-CoV555 could reduce the rate of hospitalization and symptom severity in patients with mild or moderate Covid-19.