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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
29
Administered as IV infusion.
Administered as IV infusion.
Sage Investigational Site
Fresno, California, United States
Sage Investigational Site
Augusta, Georgia, United States
Sage Investigational Site
Boston, Massachusetts, United States
Sage Investigational Site
Percentage of Participants Who Are Alive and Free of Respiratory Failure at Day 28
Respiratory failure is defined based on resource utilization, requiring at least one of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified oxygen delivered via reinforced nasal cannula at flow rates \>20 liter/minute with fraction of delivered oxygen \>=0.5), noninvasive positive pressure ventilation, and extracorporeal membrane oxygenation (ECMO). Percentage of participants who were alive and free of respiratory failure at Day 28 were reported in this outcome measure.
Time frame: Day 28
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a participant administered with a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of an IP whether or not related to the product. An AE can include any undesirable medical condition, even if no study treatment has been administered. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.
Time frame: From first dose of investigational product up to end of study (up to Day 40)
Number of Participants Who Died Through Day 28
All cause mortality was reported up to Day 28 in this outcome measure.
Time frame: From screening up to Day 28
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Burlington, Massachusetts, United States
Sage Investigational Site
Lansing, Michigan, United States
Sage Investigational Site
Las Vegas, Nevada, United States
Sage Investigational Site
Charlotte, North Carolina, United States
Sage Investigational Site
Richmond, Virginia, United States
Sage Investigational Site
Seattle, Washington, United States