Inhaled Carbon Monoxide for Acute Respiratory Distress Syndrome (ARDS)
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude participants using certain therapies like inhaled pulmonary vasodilators, so it's best to discuss your specific medications with the trial team.
Is inhaled carbon monoxide generally safe for humans?
Research suggests that low-dose inhaled carbon monoxide may have anti-inflammatory effects and could be safe for use in conditions like COPD, as it was associated with a decreased risk of hospitalization. However, more studies are needed to confirm its safety in humans, especially for different conditions like ARDS.12345
How is inhaled carbon monoxide treatment different from other treatments for ARDS?
Inhaled carbon monoxide (CO) is unique because it is being explored for its potential protective effects on cells in ARDS, a condition with no effective drug treatments. Unlike other therapies, it is administered as a gas directly into the lungs, which is different from typical drug treatments that are often given orally or intravenously.13678
What data supports the effectiveness of the treatment inhaled carbon monoxide for acute respiratory distress syndrome (ARDS)?
Research suggests that low-dose inhaled carbon monoxide may protect lung cells and reduce inflammation and stress in conditions similar to ARDS, like sepsis and acute lung injury. These protective effects have been observed in laboratory studies, indicating potential benefits for ARDS patients.19101112
Who Is on the Research Team?
Rebecca Baron, MD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for adults over 18 with ARDS, which is a severe lung condition. Participants must be intubated, have specific oxygenation and chest X-ray criteria, and not explained by heart failure. Exclusions include pregnancy, recent heart attacks or strokes, certain religious beliefs against blood transfusion, low hemoglobin levels, and unwillingness to follow the study's procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive inhaled carbon monoxide or medical air for up to 90 minutes daily for 3 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are assessed for long-term outcomes such as hospital-free days and cognitive assessments
What Are the Treatments Tested in This Trial?
Interventions
- Inhaled Carbon Monoxide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Massachusetts General Hospital
Collaborator
Weill Medical College of Cornell University
Collaborator
Duke University
Collaborator
Washington University School of Medicine
Collaborator
Durham VA Medical Center
Collaborator
New York Presbyterian Brooklyn Methodist Hospital
Collaborator
Duke Regional Hospital
Collaborator
Duke Regional Hospital
Collaborator
U.S. Army Medical Research Acquisition Activity
Collaborator