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Safety and Efficacy Study of Inhaled Carbon Monoxide to Treat Acute Respiratory Distress Syndrome (ARDS)

NCT03799874 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-08-24

No results posted yet for this study

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

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

DRUG

Inhaled Carbon Monoxide at 200 ppm

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

OTHER

Inhaled Medical air

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • Durham VA Medical Center

    collaborator FED

  • New York Presbyterian Brooklyn Methodist Hospital

    collaborator OTHER

  • Duke Regional Hospital

    collaborator OTHER

  • U.S. Army Medical Research Acquisition Activity

    collaborator FED

  • Washington University School of Medicine

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Rebecca Baron, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2026-01-31
Completion
2026-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03799874 on ClinicalTrials.gov