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

NCT04537806 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 547-ARD-301
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 9

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.

Conditions

Acute Respiratory Distress Syndrome; COVID-19

Outcome Measures

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.

  Day 28

Secondary Outcomes (2)

• Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)

  From first dose of investigational product up to end of study (up to Day 40)

• Number of Participants Who Died Through Day 28

  From screening up to Day 28

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Brexanolone

EXPERIMENTAL

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

Brexanolone DRUG

Administered as IV infusion.

Also known as: Allopregnanolone, Zulresso, SAGE-547

Brexanolone

Placebo DRUG

Administered as IV infusion.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sage Therapeutics: lead

Study Sites (9)

Sage Investigational Site

Fresno, California, 93701, United States

Location

Sage Investigational Site

Augusta, Georgia, 30912, United States

Location

Sage Investigational Site

Boston, Massachusetts, 02115, United States

Location

Sage Investigational Site

Burlington, Massachusetts, 01805, United States

Location

Sage Investigational Site

Lansing, Michigan, 48912, United States

Location

Sage Investigational Site

Las Vegas, Nevada, 89102, United States

Location

Sage Investigational Site

Charlotte, North Carolina, 28203, United States

Location

Sage Investigational Site

Richmond, Virginia, 23298, United States

Location

Sage Investigational Site

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Interventions

brexanolone; Pregnanolone

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The study was terminated early due to sponsor's decision and there were no safety concerns.

Results Point of Contact

• Title: Medical Monitor
• Organization: Sage Therapeutics

info@sagerx.com

(617) 299-8380

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 3, 2020
• Study Start: December 18, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 19, 2022
• Results First Posted: July 27, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)