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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04537806
Recruitment Status : Terminated (Internal company decision)
First Posted : September 3, 2020
Results First Posted : July 27, 2022
Last Update Posted : August 19, 2022
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome COVID-19 Drug: Brexanolone Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19
Actual Study Start Date : December 18, 2020
Actual Primary Completion Date : July 1, 2021
Actual Study Completion Date : July 1, 2021


Arm Intervention/treatment
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
Administered as IV infusion.

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
Administered as IV infusion.
Other Names:
  • Allopregnanolone
  • Zulresso
  • SAGE-547




Primary Outcome Measures :
  1. 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 (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.


Secondary Outcome Measures :
  1. Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) [ Time Frame: From first dose of investigational product up to end of study (up to Day 40) ]
    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.

  2. Number of Participants Who Died Through Day 28 [ Time Frame: From screening up to Day 28 ]
    All cause mortality was reported up to Day 28 in this outcome measure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, California
Sage Investigational Site
Fresno, California, United States, 93701
United States, Georgia
Sage Investigational Site
Augusta, Georgia, United States, 30912
United States, Massachusetts
Sage Investigational Site
Boston, Massachusetts, United States, 02115
Sage Investigational Site
Burlington, Massachusetts, United States, 01805
United States, Michigan
Sage Investigational Site
Lansing, Michigan, United States, 48912
United States, Nevada
Sage Investigational Site
Las Vegas, Nevada, United States, 89102
United States, North Carolina
Sage Investigational Site
Charlotte, North Carolina, United States, 28203
United States, Virginia
Sage Investigational Site
Richmond, Virginia, United States, 23298
United States, Washington
Sage Investigational Site
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Sage Therapeutics
  Study Documents (Full-Text)

Documents provided by Sage Therapeutics:
Study Protocol  [PDF] February 26, 2021
Statistical Analysis Plan  [PDF] November 23, 2021

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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT04537806    
Other Study ID Numbers: 547-ARD-301
First Posted: September 3, 2020    Key Record Dates
Results First Posted: July 27, 2022
Last Update Posted: August 19, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Pregnanolone
Brexanolone
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Neurosteroids
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action