A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19

• Status: Terminated
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sage Therapeutics
• Treatments: Brexanolone; Pregnanolone

Criteria

Inclusion Criteria:

• Participant has been confirmed positive for the novel coronavirus responsible for COVID-19 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) at Screening

• Participant has a presumptive diagnosis of ARDS at Screening and partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) (PF ratio) < 300 prior to randomization

• Participant is intubated and receiving mechanical ventilation prior to randomization

• Participants must have initiated mechanical ventilation within 48 hours prior to screening, or have an immediate clinical plan for such intervention at time of screening

• Participant is likely to survive, in the opinion of the investigator, for at least 72 hours from the time of screening

Exclusion Criteria:

• Participant has fulminant hepatic failure at Screening

• Participant has end stage renal disease at Screening

• Participant has a known allergy to progesterone, allopregnanolone, or any excipients in the brexanolone injection

• Be concurrently participating in another clinical trial for an investigational product or device at screening