FX06 to rescue SARS-CoV-2-induced acute respiratory distress syndrome: a randomized clinical trial.

ABSTRACT:

Background

Vascular leakage is a major feature of acute respiratory distress syndrome (ARDS). We aimed to evaluate the efficacy of FX06, a drug under development that stabilizes interendothelial cell junctions, at reducing vascular leakage during SARS-CoV-2-induced ARDS.

Methods

This multicenter, double-blinded, randomized trial included adults with COVID-19-associated ARDS who had received invasive mechanical ventilation for < 5 days and were randomized to receive either intravenous FX06 (400 mg/d, for 5 days) or its vehicle as placebo. The primary endpoint was the lowering-from day 1 to day 7-of the transpulmonary thermodilution-derived extravascular lung-water index (EVLWi).

Results

Twenty-five patients were randomized to receive FX06 and 24 the placebo. Although E

SUBMITTER: Guerin E 

PROVIDER: S-EPMC10463389 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature