Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
NCT ID:
NCT04537806
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04537806
Study Brief:
Protocol Section:
NCT04537806