Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sage Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
