Clinical trial NCT04537806: A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)
Official title: A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Respiratory Distress Syndrome
COVID-19
Lead sponsor: Sage Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-09-03
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Percentage of Participants Who Are Alive and Free of Respiratory Failure at Day 28
timeFrame: Day 28
Secondary outcomes:
measure: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: From first dose of investigational product up to end of study (up to Day 40)
measure: Number of Participants Who Died Through Day 28
timeFrame: From screening up to Day 28
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Sage Investigational Site
state: California
city: Augusta
country: United States
facility: Sage Investigational Site
state: Georgia
city: Boston
country: United States
facility: Sage Investigational Site
state: Massachusetts
city: Burlington
country: United States
facility: Sage Investigational Site
state: Massachusetts
city: Lansing
country: United States
facility: Sage Investigational Site
state: Michigan
city: Las Vegas
country: United States
facility: Sage Investigational Site
state: Nevada
city: Charlotte
country: United States
facility: Sage Investigational Site
state: North Carolina
city: Richmond
country: United States
facility: Sage Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Sage Investigational Site
state: Washington
Study officials:
References: