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NCT03799874 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Inhaled Carbon Monoxide to Treat Acute Respiratory Distress Syndrome (ARDS)
A Phase 2 study of Acute Respiratory Distress Syndrome, sponsored by Brigham and Women's Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 7
- Study locations
NCT03799874: Active Phase 2 study of Acute Respiratory Distress Syndrome, sponsored by Brigham and Women's Hospital.
NCT03799874 is a Phase 2 study of Acute Respiratory Distress Syndrome that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 32 participants, below the 366-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (91% lower). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03799874, a Phase 2 study of Acute Respiratory Distress Syndrome, is active but no longer recruiting, sponsored by Brigham and Women's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 7
- Study locations
Study Summary
This study will be a multi-center, prospective, randomized, partially double-blind, placebo-controlled Phase II clinical trial of inhaled CO (iCO) for the treatment of ARDS. The trial will be conducted at 7 tertiary care medical centers including Weill Cornell Medicine/NewYork-Presbyterian Hospital, Brigham and Women's Hospital (BWH), Massachusetts General Hospital (MGH), Duke University Hospital, Durham Veterans Administration Medical Center, New York-Presbyterian Brooklyn Methodist Hospital, and Duke Regional Hospital. The purpose of this study is to evaluate the safety, tolerability, and efficacy of inhaled carbon monoxide (iCO) for the treatment of ARDS and to examine the biologic readouts of low dose iCO therapy in patients with ARDS
Primary Outcome
Safety of inhaled CO, defined by the incidence of pre-specified administration-related AEs (as defined below) and spontaneously reported AEs through study day 7. 1. Acute 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 DC cardioversion within 48 hours of study drug administration 4. Increased oxygenation requirements defined as: an increase in FiO2 of ≥ 0.
Conditions Studied
Interventions
- OTHER Inhaled Medical air
- DRUG Inhaled Carbon Monoxide at 200 ppm
Study Locations (7)
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
New York
- New York-Presbyterian Brooklyn Methodist Hospital - Brooklyn
- Weill Cornell Medical College - New York
North Carolina
- Duke Regional Hospital - Durham
- Duke University Hospital - Durham
Missouri
- Washington University - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2026-01 |
| Phase | Phase 2 |
What the registry record for NCT03799874 still lists
NCT03799874 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 366-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Acute Respiratory Distress Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Inhaled Medical air is the first listed.
NCT03799874 lists 7 locations in 4 states (Massachusetts, New York, North Carolina).
Frequently Asked Questions
What is clinical trial NCT03799874 about?
NCT03799874 is a clinical study titled "Safety and Efficacy Study of Inhaled Carbon Monoxide to Treat Acute Respiratory Distress Syndrome (ARDS)". This study will be a multi-center, prospective, randomized, partially double-blind, placebo-controlled Phase II clinical trial of inhaled CO (iCO) for the treatment of ARDS. The trial will be conducted at 7 tertiary care medical centers including Weill Cornell Medicine/NewYork-Presbyterian Hospital,...
What is the current status of trial NCT03799874?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2019-07-01. Estimated completion is 2026-01.
What conditions does trial NCT03799874 study?
This clinical trial studies the following conditions: Acute Respiratory Distress Syndrome.
What interventions are being tested in trial NCT03799874?
The interventions under investigation include: Inhaled Medical air (OTHER), Inhaled Carbon Monoxide at 200 ppm (DRUG).
Who is sponsoring clinical trial NCT03799874?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03799874 being conducted?
This trial has 7 study locations across Massachusetts, Missouri, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Respiratory Distress Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03799874's enrollment target sits among peer trials
32 25th of 31 higher than 7 of 31 other Acute Respiratory Distress Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Respiratory Distress Syndrome 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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