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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-18

Study Completion Date

2021-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fibrinolytic Therapy to Treat ARDS in the Setting of COVID-19 Infection

NCT04357730

Severe Acute Respiratory Syndrome Respiratory Failure Acute Respiratory Distress Syndrome

COMPLETED PHASE2

Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19

NCT04565249

Acute Respiratory Distress Syndrome SARS-CoV-2

TERMINATED PHASE2

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)

NCT06703073

Acute Respiratory Distress Syndrome (ARDS) ARDS ARDS (Acute Respiratory Distress Syndrome) +1 more

RECRUITING PHASE2

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart

NCT06701669

Acute Respiratory Distress Syndrome (ARDS) ARDS ARDS (Acute Respiratory Distress Syndrome) +1 more

RECRUITING PHASE2

Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)

NCT04377620

COVID-19

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Respiratory Distress Syndrome COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered as IV infusion.

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.

Group Type EXPERIMENTAL

Brexanolone

Intervention Type DRUG

Administered as IV infusion.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brexanolone

Administered as IV infusion.

Intervention Type DRUG

Placebo

Administered as IV infusion.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Allopregnanolone Zulresso SAGE-547

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No