Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Sepsis and Acute Respiratory Distress Syndrome, sponsored by Brigham and Women's Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
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 myocardial infarction 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 incre
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 |
What the registry record for NCT04870125 still lists
NCT04870125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 6,565-participant average among 90 other Sepsis trials with a reported enrollment target (100% lower).
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 lists 6 locations in 4 states (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.
Learn More About Clinical Trials
Similar trials for Sepsis
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 NCT04870125's enrollment target sits among peer trials
5 90th of 90 the lowest of 90 other Sepsis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sepsis 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
-
Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention
RECRUITING · Phase 1
-
Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance
COMPLETED · Phase 1
-
Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis
COMPLETED · Phase 1
-
Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections
COMPLETED · Phase 1
-
Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome
COMPLETED · Phase 1
-
The APS Phenotyping Study
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI