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

Part of paid clinical trials in Fresno, California.

Sponsor
Sage Therapeutics
Study ID
NCT04537806
Phase
PHASE3
Status
Terminated

Conditions

  • Acute Respiratory Distress Syndrome
  • COVID-19

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brexanolone — DRUG
    Administered as IV infusion.
  • Placebo — DRUG
    Administered as IV infusion.

Study Details

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.

Key Dates

Start date
Dec 18, 2020
Status verified
Aug 2022
Primary completion
Jul 1, 2021
Completion
Jul 1, 2021

Study Design

Enrollment
29 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Percentage of Participants Who Are Alive and Free of Respiratory Failure at Day 28 [ Time Frame: Day 28 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Sage Investigational SiteFresnoCalifornia93701-
Sage Investigational SiteAugustaGeorgia30912-
Sage Investigational SiteBostonMassachusetts02115-
Sage Investigational SiteBurlingtonMassachusetts01805-
Sage Investigational SiteLansingMichigan48912-
Sage Investigational SiteLas VegasNevada89102-
Sage Investigational SiteCharlotteNorth Carolina28203-
Sage Investigational SiteRichmondVirginia23298-
Sage Investigational SiteSeattleWashington98122-

Find similar trials in Fresno, CA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Sage Investigational Site· Fresno, CASage Investigational Site· Augusta, GASage Investigational Site· Boston, MASage Investigational Site· Burlington, MASage Investigational Site· Lansing, MISage Investigational Site· Las Vegas, NV

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