Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial.
Publication/Presentation Date
9-1-2022
Abstract
BACKGROUND: Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection.
OBJECTIVE: To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone.
DESIGN: Double-blind, randomized, placebo-controlled, clinical trial. (ClinicalTrials.gov: NCT04501978).
SETTING: Multinational, multicenter trial.
PARTICIPANTS: Adults hospitalized with COVID-19.
INTERVENTION: Intravenous ensovibep, 600 mg, or placebo.
MEASUREMENTS: Ensovibep was assessed for early futility on the basis of pulmonary ordinal scores at day 5. The primary outcome was time to sustained recovery through day 90, defined as 14 consecutive days at home or place of usual residence after hospital discharge. A composite safety outcome that included death, serious adverse events, end-organ disease, and serious infections was assessed through day 90.
RESULTS: An independent data and safety monitoring board recommended that enrollment be halted for early futility after 485 patients were randomly assigned and received an infusion of ensovibep (
LIMITATION: The trial was prematurely stopped because of futility, limiting power for the primary outcome.
CONCLUSION: Compared with placebo, ensovibep did not improve clinical outcomes for hospitalized participants with COVID-19 receiving standard care, including remdesivir; no safety concerns were identified.
PRIMARY FUNDING SOURCE: National Institutes of Health.
Volume
175
Issue
9
First Page
1266
Last Page
1274
ISSN
1539-3704
Published In/Presented At
ACTIV-3/TICO Study Group, Barkauskas, C., Mylonakis, E., Poulakou, G., Young, B. E., Vock, D. M., Siegel, L., Engen, N., Grandits, G., Mosaly, N. R., Vekstein, A. M., Rogers, R., Shehadeh, F., Kaczynski, M., Mylona, E. K., Syrigos, K. N., Rapti, V., Lye, D. C., Hui, D. S., Leither, L., … Lundgren, J. D. (2022). Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial. Annals of internal medicine, 175(9), 1266–1274. https://doi.org/10.7326/M22-1503
Disciplines
Medicine and Health Sciences
PubMedID
35939810
Department(s)
Department of Medicine
Document Type
Article