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Gasotransmitter

Inhaled Carbon Monoxide for Acute Respiratory Distress Syndrome (ARDS)

Phase 2
Waitlist Available
Led By Rebecca Baron, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months

Summary

This trial will study inhaled carbon monoxide (iCO) as a potential treatment for ARDS, testing its safety, tolerability, and efficacy. The trial will be conducted at 7 tertiary care medical centers.

Who is the study for?
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.
What is being tested?
The study tests inhaled carbon monoxide (iCO) at 200 ppm versus medical air to see if iCO can safely treat ARDS. It's conducted across several hospitals and includes patients randomly assigned to either treatment without knowing which one they receive (partially double-blind).
What are the potential side effects?
Potential side effects of inhaled carbon monoxide may include headache, dizziness, nausea, increased heart rate or chest pain due to its effect on oxygen delivery in the body; however specifics will be monitored closely given it's a safety trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Efficacy Outcome: Change in Mitochondrial DNA (mtDNA) level from day 1 to day 5
Primary Safety Outcome: Number of pre-specified administration-related adverse events.
Secondary study objectives
Change in biomarkers of autophagy
Change in biomarkers of inflammation and inflammasome activation
Change in biomarkers of mitochondrial quality control
+6 more
Other study objectives
Hayling Sentence Completion Test
Hospital mortality to day 28 and 60
Hospital-free days at day 60
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Inhaled Carbon MonoxideExperimental Treatment1 Intervention
Inhaled Carbon Monoxide at 200 ppm for up to 90 minutes daily for 3 days.
Group II: Medical airPlacebo Group1 Intervention
Inhaled Medical Air for up to 90 minutes daily for 3 days.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER
3,017 Previous Clinical Trials
13,309,663 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,088 Previous Clinical Trials
1,154,965 Total Patients Enrolled
Duke UniversityOTHER
2,455 Previous Clinical Trials
2,971,520 Total Patients Enrolled

Media Library

Inhaled Carbon Monoxide (Gasotransmitter) Clinical Trial Eligibility Overview. Trial Name: NCT03799874 — Phase 2
Acute Respiratory Distress Syndrome Research Study Groups: Inhaled Carbon Monoxide, Medical air
Acute Respiratory Distress Syndrome Clinical Trial 2023: Inhaled Carbon Monoxide Highlights & Side Effects. Trial Name: NCT03799874 — Phase 2
Inhaled Carbon Monoxide (Gasotransmitter) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03799874 — Phase 2
~4 spots leftby Sep 2025
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