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

Sage Therapeutics

Status and phase: Terminated; Phase 3

Conditions: COVID-19; Acute Respiratory Distress Syndrome

Treatments: Drug: Placebo; Drug: Brexanolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT04537806

547-ARD-301

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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29 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants receiving mechanical ventilation as standard of care were randomized to receive a 60-hour single continuous intravenous (IV) infusion of brexanolone-matching placebo.

Treatment:

Drug: Placebo

Brexanolone

Experimental group

Description:

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.

Treatment:

Drug: Brexanolone