Fc-Modified Antibody in Hospitalized Severe COVID-19 Patients.

ABSTRACT: Background: Hospitalized patients with severe COVID-19 are at high risk of clinical deterioration. Methods: A global, randomized, double-blinded, and placebo-controlled phase II trial that investigated the clinical efficacy of SCTA01, an Fc-modified monoclonal antibody, in patients hospitalized with severe COVID-19 during the Delta variant wave was performed. The primary outcome was time to clinical improvement up to Day 29. Secondary outcomes measured the all-cause mortality rate up to Day 29, time to SARS-CoV-2 RNA negativity up to Day 29, and the number of antibody-dependent enhancements. Results: From 27 March 2021, to 11 February 2022, 102 hospitalized adults with severe COVID-19 received a single intravenous infusion of SCTA01 15 mg/kg or 50 mg/kg or placebo in a

SUBMITTER: Dal-Pizzol F 

PROVIDER: S-EPMC12031629 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature