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NCT02425579 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Inhaled Carbon Monoxide to Treat Acute Respiratory Distress Syndrome (ARDS)
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT02425579: Completed Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT02425579 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02425579, a Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety of inhaled carbon monoxide (iCO) in intubated patients with sepsis-induced ARDS.
Primary Outcome
1. Acute myocardial infarction (MI) within 48 hours of study drug administration 2. Acute cerebrovascular accident (CVA) within 48 hours of study drug administration 3. New onset atrial or ventricular arrhythmia requiring direct current (DC) cardioversion within 48 hours of study drug administration 4. Increased oxygenation requirements defined as: an increase in fraction of inspired oxygen (FiO2) of greater than or equal to 0.2 AND increase in PEEP greater than or equal to 5 cm of water (H2O) w
Interventions
- DRUG Inhaled Carbon Monoxide at 100ppm (4 participants)
- DRUG Placebo for Inhaled Carbon Monoxide at 100ppm (2 participants)
- DRUG Inhaled Carbon Monoxide at 200ppm (4 participants)
- DRUG Placebo for Inhaled Carbon Monoxide at 200ppm (2 participants)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2015-04 |
| Est. Completion | 2019-08 |
| Phase | Phase 1 |
What the finished NCT02425579 record still lists
NCT02425579 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 4 interventions - of which Inhaled Carbon Monoxide at 100ppm (4 participants) is the first listed.
NCT02425579 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02425579 about?
NCT02425579 is a clinical study titled "Safety Study of Inhaled Carbon Monoxide to Treat Acute Respiratory Distress Syndrome (ARDS)". The purpose of this study is to assess the safety of inhaled carbon monoxide (iCO) in intubated patients with sepsis-induced ARDS.
What is the current status of trial NCT02425579?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2015-04. Estimated completion is 2019-08.
What interventions are being tested in trial NCT02425579?
The interventions under investigation include: Inhaled Carbon Monoxide at 100ppm (4 participants) (DRUG), Placebo for Inhaled Carbon Monoxide at 100ppm (2 participants) (DRUG), Inhaled Carbon Monoxide at 200ppm (4 participants) (DRUG), Placebo for Inhaled Carbon Monoxide at 200ppm (2 participants) (DRUG).
Who is sponsoring clinical trial NCT02425579?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02425579's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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