Safety and Efficacy of Dupilumab for the Treatment of Hospitalized Patients With Moderate to Severe Coronavirus Disease 2019: A Phase 2a Trial.

ABSTRACT:

Background

Based on studies implicating the type 2 cytokine interleukin 13 (IL-13) as a potential contributor to critical coronavirus disease 2019 (COVID-19), this trial was designed as an early phase 2 study to assess dupilumab, a monoclonal antibody that blocks IL-13 and interleukin 4 signaling, for treatment of inpatients with COVID-19.

Methods

We conducted a phase 2a randomized, double-blind, placebo-controlled trial (NCT04920916) to assess the safety and efficacy of dupilumab plus standard of care vs placebo plus standard of care in mitigating respiratory failure and death in those hospitalized with COVID-19.

Results

Forty eligible subjects were enrolled from June to November of 2021. There was no statistically significant difference in adverse events nor in the

SUBMITTER: Sasson J 

PROVIDER: S-EPMC9361171 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature