A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19
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|ClinicalTrials.gov Identifier: NCT04537806|
Recruitment Status : Not yet recruiting
First Posted : September 3, 2020
Last Update Posted : September 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome COVID-19||Drug: Brexanolone Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19|
|Estimated Study Start Date :||November 2020|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
Participants receiving mechanical ventilation as standard of care will receive brexanolone as a single, continuous, intravenous (IV) infusion for 60 hours.
Brexanolone, intravenous (IV) infusion.
Placebo Comparator: Placebo
Participants receiving mechanical ventilation as standard of care will receive matching placebo as a single, continuous, IV infusion for 60 hours.
Placebo, IV infusion.
- Percentage of Participants Who are Alive and Free of Respiratory Failure at Day 28 [ Time Frame: 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; noninvasive positive pressure ventilation or extracorporeal membrane oxygenation (ECMO).
- Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) [ Time Frame: Up to Day 28 ]
- All-cause Mortality Through Day 28 [ Time Frame: Up to Day 28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04537806
|Contact: Ariel Brown, PhDemail@example.com|