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

Phase 3

Terminated

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Participant was confirmed positive for the novel coronavirus responsible for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection as determined by polymerase chain reaction (PCR) at Screening
Participant had a presumptive diagnosis of ARDS at Screening and partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) (ratio of partial pressure of arterial oxygen to fraction of inspired oxygen [PF ratio]) less than (<) 300 prior to randomization
Participant was intubated and receiving mechanical ventilation prior to randomization
Participants must had initiated mechanical ventilation within 48 hours prior to screening, or had an immediate clinical plan for such intervention at time of screening
Participant was likely to survive, in the opinion of the investigator, for at least 72 hours from the time of screening

Exclusion Criteria

Participant had fulminant hepatic failure at Screening
Participant had end stage renal disease at Screening
Participant had a known allergy to progesterone, allopregnanolone, or any excipients in the brexanolone injection
Participant was concurrently participating in another clinical trial for an investigational product or device at screening

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants receiving mechanical ventilation as standard of care were randomized to receive a 60-hour single continuous intravenous (IV) infusion of brexanolone-matching placebo.
Brexanolone	Brexanolone	Participants receiving mechanical ventilation as standard of care were randomized to receive a 60-hour single continuous IV infusion of brexanolone at 70 micrograms per kilogram per hour (mcg/kg/h) for 58 hours followed by a 2-hour taper of brexanolone at 35 mcg/kg/h.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Are Alive and Free of Respiratory Failure at Day 28	Day 28	Respiratory failure is defined based on resource utilization, requiring at least one of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified oxygen delivered via reinforced nasal cannula at flow rates \>20 liter/minute with fraction of delivered oxygen \>=0.5), noninvasive positive pressure ventilation, and extracorporeal membrane oxygenation (ECMO). Percentage of participants who were alive and free of respiratory failure at Day 28 were reported in this outcome measure.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)	From first dose of investigational product up to end of study (up to Day 40)	An adverse event (AE) is any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.
Number of Participants Who Died Through Day 28	From screening up to Day 28	All cause mortality was reported up to Day 28 in this outcome measure.