A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)

Summary

The purpose of this study was to evaluate the efficacy and safety of brexanolone in participants on ventilator support for acute respiratory distress syndrome (ARDS) due to COVID-19.

Timeline

Start

2020-12-18

Primary completion

2021-07-01

Completion

2021-07-01

Outcome

Missed primary endpoint

Stopped: “Internal company decision”

registry analysis (superiority test); Placebo vs Brexanolone; p = 1.0000; Proc Genmod 0.0 (95% CI -31.8 to 31.8); Chi-squared NCT04537806 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brexanolone	Unknown	70 ug/kg	Intravenous

Indications