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

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