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A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04537806
Recruitment Status : Not yet recruiting
First Posted : September 3, 2020
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
The purpose of this study is 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)
Estimated Enrollment : 100 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
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021


Arm Intervention/treatment
Experimental: Brexanolone
Participants receiving mechanical ventilation as standard of care will receive brexanolone as a single, continuous, intravenous (IV) infusion for 60 hours.
Drug: Brexanolone
Brexanolone, intravenous (IV) infusion.
Other Names:
  • Allopregnanolone
  • Zulresso
  • SAGE-547

Placebo Comparator: Placebo
Participants receiving mechanical ventilation as standard of care will receive matching placebo as a single, continuous, IV infusion for 60 hours.
Drug: Placebo
Placebo, IV infusion.




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; noninvasive positive pressure ventilation or extracorporeal membrane oxygenation (ECMO).


Secondary Outcome Measures :
  1. Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) [ Time Frame: Up to Day 28 ]
  2. All-cause Mortality Through Day 28 [ Time Frame: Up to Day 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 has been confirmed positive for the novel coronavirus responsible for COVID-19 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) at Screening
  • Participant has a presumptive diagnosis of ARDS at Screening and partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) (PF ratio) < 300 prior to randomization
  • Participant is intubated and receiving mechanical ventilation prior to randomization
  • Participants must have initiated mechanical ventilation within 48 hours prior to screening, or have an immediate clinical plan for such intervention at time of screening
  • Participant is likely to survive, in the opinion of the investigator, for at least 72 hours from the time of screening

Exclusion Criteria:

  • Participant has fulminant hepatic failure at Screening
  • Participant has end stage renal disease at Screening
  • Participant has a known allergy to progesterone, allopregnanolone, or any excipients in the brexanolone injection
  • Be 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


Contacts
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Contact: Ariel Brown, PhD 617-949-4274 ariel.brown@sagerx.com

Sponsors and Collaborators
Sage Therapeutics
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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
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Pregnanolone
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs