Acute Respiratory Distress SyndromePhase 3NCT04537806
A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)
A Phase 3 study testing Brexanolone in people with Acute Respiratory Distress Syndrome and COVID-19, run by Sage Therapeutics at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, COVID-19
- What is being tested?
- Brexanolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 9 sitesUnited States
- Study dates
- 18 Dec 2020to 1 Jul 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Sage Investigational Site
Augusta, Georgia, 30912
Sage Investigational Site
Boston, Massachusetts, 02115
Sage Investigational Site
Burlington, Massachusetts, 01805
Sage Investigational Site
Charlotte, North Carolina, 28203
Sage Investigational Site
Fresno, California, 93701
Sage Investigational Site
Lansing, Michigan, 48912
Sage Investigational Site
Las Vegas, Nevada, 89102
Sage Investigational Site
Richmond, Virginia, 23298
Sage Investigational Site
Seattle, Washington, 98122
About this study
Official title: A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19
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.
- Conditions
- Acute Respiratory Distress Syndrome, COVID-19
- Being tested
- Brexanolone, Placebo
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrexanoloneDrug
Also called Allopregnanolone, Zulresso, SAGE-547
Administered as IV infusion.
PlaceboDrug
Administered as IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants receiving mechanical ventilation as standard of care were randomized to receive a 60-hour single continuous intravenous (IV) infusion of brexanolone-matching placebo. Receives: Drug: Placebo |
| Brexanolone | Experimental | 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. Receives: Drug: Brexanolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Are Alive and Free of Respiratory Failure at 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.
Measured: Day 28
Secondary outcomes (2)
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
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.
Measured: From first dose of investigational product up to end of study (up to Day 40)
Number of Participants Who Died Through Day 28
All cause mortality was reported up to Day 28 in this outcome measure.
Measured: From screening up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start18 Dec 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Why it stopped: Internal company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sage Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537806
- Sponsor's protocol ID
- 547-ARD-301
- Status last verified
- Aug 2022
- First submitted
- 1 Sep 2020
- Last updated
- 19 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19
- ClinicalTrials.gov ID
- NCT04537806
- Acronym / sponsor ID
- 547-ARD-301
- Conditions
- Acute Respiratory Distress Syndrome, COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Internal company decision
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Sage TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Posted 27 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants receiving mechanical ventilation as standard of care were randomized to receive a 60-hour single continuous intravenous (IV) infusion of brexanolone-matching placebo. |
| Brexanolone | Experimental | Drug: BrexanoloneParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrexanoloneAlso: Allopregnanolone, Zulresso, SAGE-547Administered as IV infusion. | Drug | Brexanolone |
| PlaceboAdministered as IV infusion. | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
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)
Number of Participants Who Died Through Day 28
Time frame: From screening up to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brexanolone in people with Acute Respiratory Distress Syndrome and COVID-19, run by Sage Therapeutics at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Are Alive and Free of Respiratory Failure at Day 28 (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.