Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Recruiting
First Posted : September 3, 2020
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Tracking Information
First Submitted Date  ICMJE September 1, 2020
First Posted Date  ICMJE September 3, 2020
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE December 18, 2020
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2020)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2020)
  • Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) [ Time Frame: Up to Day 28 ]
  • All-cause Mortality Through Day 28 [ Time Frame: Up to Day 28 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19
Official Title  ICMJE A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Respiratory Distress Syndrome
  • COVID-19
Intervention  ICMJE
  • Drug: Brexanolone
    Brexanolone, intravenous (IV) infusion.
    Other Names:
    • Allopregnanolone
    • Zulresso
    • SAGE-547
  • Drug: Placebo
    Placebo, IV infusion.
Study Arms  ICMJE
  • Experimental: Brexanolone
    Participants receiving mechanical ventilation as standard of care will receive brexanolone as a single, continuous, intravenous (IV) infusion for 60 hours.
    Intervention: Drug: Brexanolone
  • Placebo Comparator: Placebo
    Participants receiving mechanical ventilation as standard of care will receive matching placebo as a single, continuous, IV infusion for 60 hours.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 1, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ariel Brown, PhD 617-949-4274 ariel.brown@sagerx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04537806
Other Study ID Numbers  ICMJE 547-ARD-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Responsible Party Sage Therapeutics
Study Sponsor  ICMJE Sage Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sage Therapeutics
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP