A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)

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• COVID-19 7,640
• Respiratory Distress Syndrome 1,597
• Respiratory Distress Syndrome, Newborn 1,179
• Acute Lung Injury 989
• Syndrome 9,217

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 29 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Lead sponsor

Sage Therapeutics is the lead sponsor of 6 studies on the registry; none are open to participants now.

Study arms

• Placebo comparator
  Placebo

  Participants receiving mechanical ventilation as standard of care were randomized to receive a 60-hour single continuous intravenous (IV) infusion of brexanolone-matching placebo.

  Drug: Placebo

• Experimental
  Brexanolone

  Participants receiving mechanical ventilation as standard of care were randomized to receive a 60-hour single continuous IV infusion of brexanolone at 70 micrograms per kilogram per hour (mcg/kg/h) for 58 hours followed by a 2-hour taper of brexanolone at 35 mcg/kg/h.

  Drug: Brexanolone

Interventions

• DrugBrexanolone

  Administered as IV infusion.

  Also known as: Allopregnanolone, Zulresso, SAGE-547

• DrugPlacebo

  Administered as IV infusion.

Primary outcomes

1. 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

Secondary outcomes

1. 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)

2. 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

Baseline characteristics

Study documents

• Study protocol · Feb 26, 2021
• Statistical analysis plan · Nov 23, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.