Enrollment stopped for futility based on no difference in pulmonary function on day 5 compared with placebo
MONDAY, Dec. 28, 2020 (HealthDay News) — The neutralizing monoclonal antibody LY-CoV555, given in conjunction with remdesivir, is not efficacious for hospitalized patients with COVID-19 without end-organ failure, according to a study published online Dec. 22 in the New England Journal of Medicine.
Jens D. Lundgren, M.D., from the CHIP Center of Excellence for Health, Immunity, and Infections in Copenhagen, Denmark, and colleagues randomly assigned hospitalized patients with COVID-19 without end-organ failure to receive either LY-CoV555 or matching placebo in a 1:1 ratio. All patients also received high-quality supportive care as background therapy, including remdesivir and supplemental oxygen and glucocorticoids when indicated. During a one-hour period, LY-CoV555 or placebo was administered as a single intravenous infusion.
The data and safety monitoring board recommended stopping enrollment for futility after 314 patients (163 in the LY-CoV555 group and 151 in the placebo group) had undergone randomization and infusion on Oct. 26, 2020. The researchers found that at day 5, 50 and 54 percent of patients in the LY-CoV555 and placebo groups, respectively, were in one of the two most favorable categories of the pulmonary outcome. The odds ratio was 0.85 for being in a more favorable category in the LY-CoV555 group versus the placebo group (95 percent confidence interval, 0.56 to 1.29; P = 0.45). The percentage of patients with the primary safety outcome was similar in the LY-CoV555 and placebo groups (19 and 14 percent, respectively; odds ratio, 1.56; 95 percent confidence interval, 0.78 to 3.10; P = 0.20).
“These results indicate a low likelihood that LY-CoV555 improves outcomes among hospitalized patients with COVID-19,” the authors write.
Several authors disclosed financial ties to the biopharmaceutical industry. Trial medications were donated by Gilead Sciences and Eli Lilly.
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