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

Oct 2020  
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Interim analysis of the BLAZE-1 phase 2 trial of outpatients showing lower hospitalization or ER visits (1.6% versus 6.3%), and improvements in symptoms and viral load compared to placebo. NCT04427501 (history).
Efficacy is highly variant dependent. In Vitro research suggests a lack of efficacy for omicron Liu, Sheward, VanBlargan.
risk of hospitalization, 74.3% lower, RR 0.26, p = 0.02, treatment 5 of 309 (1.6%), control 9 of 143 (6.3%), NNT 21.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Chen et al., 28 Oct 2020, Randomized Controlled Trial, USA, peer-reviewed, 12 authors, study period 17 June, 2020 - 5 September, 2020, average treatment delay 4.0 days, trial NCT04427501 (history).
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SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19
M.D Peter Chen, M.D Ajay Nirula, Ph.D Barry Heller, M.D Robert L Gottlieb, Ph.D Joseph Boscia, M.D Jason Morris, M.D Gregory Huhn, 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, Ph.D Kenneth L Custer, Ph.D Lei Shen, M.S Michael Durante, M.D Gerard Oakley, M.D Andrew E Schade, Ph.D Janelle Sabo, Pharm.D Dipak R Patel, Ph.D Paul Klekotka, Ph.D Daniel M Skovronsky
New England Journal of Medicine, doi:10.1056/nejmoa2029849
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 lifethreatening. 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 number, NCT04427501.
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