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NCT04870125 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Inhaled Carbon Monoxide to Treat Pneumonia and Sepsis-Induced Acute Respiratory Distress Syndrome (ARDS)
A Phase 1 study of Sepsis and Acute Respiratory Distress Syndrome, sponsored by Brigham and Women's Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 6
- Study locations
NCT04870125 is a Phase 1 study of Sepsis and Acute Respiratory Distress Syndrome that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 5 participants, below the 6,565-participant average among 90 other Sepsis trials with a reported enrollment target (100% lower). The trial reports 6 study locations across 4 states.
The verdict
NCT04870125, a Phase 1 study of Sepsis and Acute Respiratory Distress Syndrome, is active but no longer recruiting, sponsored by Brigham and Women's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 6
- Study locations
Study Summary
This study is a multi-center, randomized, partially double-blind, and placebo-controlled Phase Ib clinical trial of inhaled CO (iCO) for the treatment of sepsis-induced acute respiratory distress syndrome (ARDS). The purpose of this study is to evaluate the safety and accuracy of a Coburn-Forster-Kane (CFK) equation-based personalized iCO dosing algorithm to achieve a target carboxyhemoglobin (COHb) level of 6-8% in patients with sepsis-induced ARDS. We will also examine the biologic readouts of low dose iCO therapy in patients with sepsis-induced ARDS.
Conditions Studied
Interventions
- DRUG Inhaled Carbon Monoxide at CFK equation-determined personalized dose (200-500 ppm to achieve a COHb level of 6-8%)
- OTHER Inhaled Medical air
Study Locations (6)
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
Missouri
- Washington University - St Louis
North Carolina
- Duke University Hospital - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2023-12-06 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04870125
The ClinicalTrials.gov registry entry for NCT04870125 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,565-participant average among 90 other Sepsis trials with a reported enrollment target (100% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Sepsis appearing as the primary indexed condition, and to 2 interventions - of which Inhaled Carbon Monoxide at CFK equation-determined personalized dose (200-500 ppm to achieve a COHb level of 6-8%) is the first listed.
NCT04870125 reports 6 study locations spanning 4 distinct geographic areas - top geographies include Massachusetts, New York, Missouri.
Frequently Asked Questions
What is clinical trial NCT04870125 about?
NCT04870125 is a clinical study titled "Safety Study of Inhaled Carbon Monoxide to Treat Pneumonia and Sepsis-Induced Acute Respiratory Distress Syndrome (ARDS)". This study is a multi-center, randomized, partially double-blind, and placebo-controlled Phase Ib clinical trial of inhaled CO (iCO) for the treatment of sepsis-induced acute respiratory distress syndrome (ARDS). The purpose of this study is to evaluate the safety and accuracy of a Coburn-Forster-Ka...
What is the current status of trial NCT04870125?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2023-12-06. Estimated completion is 2026-03-31.
What conditions does trial NCT04870125 study?
This clinical trial studies the following conditions: Sepsis, Acute Respiratory Distress Syndrome.
What interventions are being tested in trial NCT04870125?
The interventions under investigation include: Inhaled Carbon Monoxide at CFK equation-determined personalized dose (200-500 ppm to achieve a COHb level of 6-8%) (DRUG), Inhaled Medical air (OTHER).
Who is sponsoring clinical trial NCT04870125?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04870125 being conducted?
This trial has 6 study locations across Massachusetts, Missouri, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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