Responses to a Neutralizing Monoclonal Antibody for Hospitalized Patients With COVID-19 According to Baseline Antibody and Antigen Levels : A Randomized Controlled Trial.

ABSTRACT:

Background

In a randomized, placebo-controlled, clinical trial, bamlanivimab, a SARS-CoV-2-neutralizing monoclonal antibody, given in combination with remdesivir, did not improve outcomes among hospitalized patients with COVID-19 based on an early futility assessment.

Objective

To evaluate the a priori hypothesis that bamlanivimab has greater benefit in patients without detectable levels of endogenous neutralizing antibody (nAb) at study entry than in those with antibodies, especially if viral levels are high.

Design

Randomized, placebo-controlled trial. (ClinicalTrials.gov: NCT04501978).

Setting

Multicenter trial.

Patients

Hospitalized patients with COVID-19 without end-organ failure.

Intervention

Bamlanivimab (7000 mg) or placebo.

Measurement

SUBMITTER: ACTIV-3/TICO Bamlanivimab Study Group 

PROVIDER: S-EPMC9334931 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature