CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled / 4 target
Drug / intervention
Inhaled Carbon Monoxide at 200 ppm +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03799874
NCT03799874Phase 2CompletedUpdate Overdue (0.1/mo)Completion was 62mo ago
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A Phase II Trial of Inhaled Carbon Monoxide for the Treatment of Acute Respiratory Distress Syndrome (ARDS)

Brigham and Women's Hospital·interventional·Posted Jan 10, 2019·Updated Jun 16, 2026

In Brief

A Phase 2 clinical trial evaluating Inhaled Carbon Monoxide at 200 ppm and Inhaled Medical air for Acute Respiratory Distress Syndrome. Completed, enrolled 4 participants across 7 sites.

Signals

Enrollment appears stalled

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Respiratory Distress Syndrome
CountriesUnited States
CollaboratorsMassachusetts General Hospital, Weill Medical College of Cornell University, Duke University, Durham VA Medical Center, New York Presbyterian Brooklyn Methodist Hospital, Duke Regional Hospital, U.S. Army Medical Research Acquisition Activity, Washington University School of Medicine

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 10, 2019
Enrollment StartSep 30, 2019
Primary CompletionApr 13, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.5 years ago

Arms & Interventions

Inhaled Carbon Monoxideexperimental

Inhaled Carbon Monoxide at 200 ppm for up to 90 minutes daily for 3 days.

Drug: Inhaled Carbon Monoxide at 200 ppm
Medical airplacebo_comparator

Inhaled Medical Air for up to 90 minutes daily for 3 days.

Other: Inhaled Medical air

Interventions

Inhaled Carbon Monoxide at 200 ppmdrug

Inhaled Carbon Monoxide at 200 ppm for 90 minutes daily for 3 days.

Inhaled Medical airother

Inhaled Medical Air for up to 90 minutes daily for 3 days.