COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04537806

Ariel Brown, PhD

ariel.brown@sagerx.com

2020-09-03

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

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

2

Sage Therapeutics

18

100

United States

Critical disease at enrollment

8: Critical disease at enrollment

29

Percentage of Participants Who are Alive and Free of Respiratory Failure at Day 28

None

Phase 3

[{"arm_notes": "", "treatment_id": 235, "treatment_name": "Brexanolone", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]