Inhaled Carbon Monoxide for Acute Respiratory Distress Syndrome (ARDS)

Recruiting at6 trial locations

Overseen by Rebecca Baron, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Brigham and Women's Hospital

Prior Safety Data

Trial Summary

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

Research Team

Rebecca Baron, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

All intubated patients ≥ 18 years old with ARDS

ARDS is defined when all four of the following criteria are met:

A PaO2/FiO2 ratio ≤ 300 with at least 5 cm H2O positive end-expiratory airway pressure (PEEP)

Exclusion Criteria

Subjects who are Jehovah's Witnesses or are otherwise unable or unwilling to receive blood transfusions during hospitalization

No arterial or central line/no intent to place an arterial or central line

Diffuse alveolar hemorrhage from vasculitis

Treatment Details

Interventions

• Inhaled Carbon Monoxide (Gasotransmitter)

Trial Overview 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).

Participant Groups

Group I: Inhaled Carbon Monoxide Experimental Treatment 1 Intervention

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

Group II: Medical air Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Dr. Robert Min

Weill Medical College of Cornell University

Chief Executive Officer since 2024

MD, MBA

Dr. Adam R. Stracher

Weill Medical College of Cornell University

Chief Medical Officer since 2024

MD

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

David H. Perlmutter

Washington University School of Medicine

Chief Executive Officer since 2015

MD from Washington University School of Medicine

Paul Scheel

Washington University School of Medicine

Chief Medical Officer since 2022

MD from Washington University School of Medicine

Durham VA Medical Center

Collaborator

Trials

40

Recruited

9,300+

New York Presbyterian Brooklyn Methodist Hospital

Collaborator

Trials

21

Recruited

3,900+

Duke Regional Hospital

Collaborator

Trials

2

Recruited

2,400+

Duke Regional Hospital

Collaborator

Trials

2

Recruited

2,400+

U.S. Army Medical Research Acquisition Activity

Collaborator

Trials

26

Recruited

10,500+