Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial.

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 su

SUBMITTER: ACTIV-3/TICO Study Group 

PROVIDER: S-EPMC9384272 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature