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Safety and Efficacy Study of Inhaled Carbon Monoxide to Treat Acute Respiratory Distress Syndrome (ARDS)
Sponsor: Brigham and Women's Hospital
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
Official title: A Phase II Trial of Inhaled Carbon Monoxide for the Treatment of Acute Respiratory Distress Syndrome (ARDS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2019-07-01
Completion Date
2026-01
Last Updated
2025-08-24
Healthy Volunteers
No
Conditions
Interventions
Inhaled Carbon Monoxide at 200 ppm
Inhaled Carbon Monoxide at 200 ppm for 90 minutes daily for 3 days.
Inhaled Medical air
Inhaled Medical Air for up to 90 minutes daily for 3 days.
Locations (7)
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
Weill Cornell Medical College
New York, New York, United States
Duke Regional Hospital
Durham, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States