Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19
Clinical endpoint
Cumulative incidence
DOI:
10.7326/m22-1503
Publication Date:
2022-08-08T21:00:22Z
AUTHORS (1171)
ABSTRACT
Ensovibep (MP0420) is a designed ankyrin repeat protein, novel class of engineered proteins, under investigation as treatment SARS-CoV-2 infection.To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared care alone.Double-blind, randomized, placebo-controlled, trial. (ClinicalTrials.gov: NCT04501978).Multinational, multicenter trial.Adults COVID-19.Intravenous 600 mg, or placebo.Ensovibep was assessed for early futility on the basis pulmonary ordinal scores at day 5. The primary outcome time sustained recovery through 90, defined 14 consecutive days home place usual residence after hospital discharge. A composite safety that included death, serious adverse events, end-organ disease, infections 90.An independent data monitoring board recommended enrollment be halted 485 were randomly assigned received an infusion ensovibep (n = 247) placebo 238). odds ratio (OR) more favorable (vs. placebo) group 5 0.93 (95% CI, 0.67 1.30; P 0.68; OR > 1 would favor ensovibep). 90-day cumulative incidence 82% 80% (subhazard [sHR], 1.06 [CI, 0.88 1.28]; sHR 90 occurred 78 participants (32%) 70 (29%) (HR, 1.07 0.77 1.47]; HR < ensovibep).The trial prematurely stopped because futility, limiting power outcome.Compared placebo, did not improve receiving including remdesivir; no concerns identified.National Institutes Health.
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