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

COVID-19 Clinical Trial

Official title:

A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04537806
• Other study ID #: 547-ARD-301
• Status: Terminated
• Phase: Phase 3
• Start date: December 18, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2022
• Source: Sage Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• Brexanolone
Administered as IV infusion.
• Placebo
Administered as IV infusion.

Locations

Country	Name	City	State
United States	Sage Investigational Site	Augusta	Georgia
United States	Sage Investigational Site	Boston	Massachusetts
United States	Sage Investigational Site	Burlington	Massachusetts
United States	Sage Investigational Site	Charlotte	North Carolina
United States	Sage Investigational Site	Fresno	California
United States	Sage Investigational Site	Lansing	Michigan
United States	Sage Investigational Site	Las Vegas	Nevada
United States	Sage Investigational Site	Richmond	Virginia
United States	Sage Investigational Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Sage Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 28
Secondary	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.	From first dose of investigational product up to end of study (up to Day 40)
Secondary	Number of Participants Who Died Through Day 28	All cause mortality was reported up to Day 28 in this outcome measure.	From screening up to Day 28