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

Type Journal Article Author Peter Chen Author Ajay Nirula Author Barry Heller Author Robert L. Gottlieb Author Joseph Boscia Author Jason Morris Author Gregory Huhn Author Jose Cardona Author Bharat Mocherla Author Valentina Stosor Author Imad Shawa Author Andrew C. Adams Author Jacob Van Naarden Author Kenneth L. Custer Author Lei Shen Author Michael Durante Author Gerard Oakley Author Andrew E. Schade Author Janelle Sabo Author Dipak R. Patel Author Paul Klekotka Author Daniel M. Skovronsky URL https://www.nejm.org/doi/10.1056/NEJMoa2029849 Rights Copyright © 2020 Massachusetts Medical Society. All rights reserved. Publication New England Journal of Medicine Date 28/10/2020 Loc. in Archive world Extra Publisher: Massachusetts Medical Society DOI 10.1056/NEJMoa2029849 Library Catalog www.nejm.org Language en Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (Covid-19), which is most frequently mild yet can be severe and life-threatening. Virus-neutralizing monoclonal antibodies are predicted to reduce viral load, ameliorate symptoms, and prevent hospitalization. Methods In this ongoing phase 2 trial involving outpatients with recently diagnosed mild or moderate Covid-19, we randomly assigned 452 patients to receive a single intravenous infusion of neutralizing antibody LY-CoV555 in one of three doses (700 mg, 2800 mg, or 7000 mg) or placebo and evaluated the quantitative virologic end points and clinical outcomes. The primary outcome was the change from baseline in the viral load at day 11. The results of a preplanned interim analysis as of September 5, 2020, are reported here. Results At the time of the interim analysis, the observed mean decrease from baseline in the log viral load for the entire population was −3.81, for an elimination of more than 99.97% of viral RNA. For patients who received the 2800-mg dose of LY-CoV555, the difference from placebo in the decrease from baseline was −0.53 (95% confidence interval [CI], −0.98 to −0.08; P=0.02), for a viral load that was lower by a factor of 3.4. Smaller differences from placebo in the change from baseline were observed among the patients who received the 700-mg dose (−0.20; 95% CI, −0.66 to 0.25; P=0.38) or the 7000-mg dose (0.09; 95% CI, −0.37 to 0.55; P=0.70). On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo. The percentage of patients who had a Covid-19–related hospitalization or visit to an emergency department was 1.6% in the LY-CoV555 group and 6.3% in the placebo group. Conclusions In this interim analysis of a phase 2 trial, one of three doses of neutralizing antibody LY-CoV555 appeared to accelerate the natural decline in viral load over time, whereas the other doses had not by day 11. (Funded by Eli Lilly; BLAZE-1 ClinicalTrials.gov number, NCT04427501. opens in new tab.)