A Randomized Double-Blinded Placebo Controlled Trial of Clazakizumab for the Treatment of COVID-19 Pneumonia With Hyperinflammation.

ABSTRACT:

Objectives

We designed this study to test whether clazakizumab, a direct interleukin-6 inhibitor, benefits patients hospitalized with severe or critical COVID-19 disease accompanied by hyperinflammation.

Design

Multicenter, randomized, double-blinded, placebo-controlled, seamless phase II/III trial.

Setting

Five U.S. medical centers.

Patients

Adults inpatients with severe COVID-19 disease and hyperinflammation.

Interventions

Eighty-one patients enrolled in phase II, randomized 1:1:1 to low-dose (12.5 mg) or high-dose (25 mg) clazakizumab or placebo. Ninety-seven patients enrolled in phase III, randomized 1:1 to high-dose clazakizumab or placebo.

Measurements and main results

The primary outcome was 28-day ventilator-free survival. Secondary outcom

SUBMITTER: Lonze BE 

PROVIDER: S-EPMC9380150 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature