Inhaled Carbon Monoxide for ARDS

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen by Rebecca Baron, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Brigham and Women's Hospital

Trial Summary

What is the purpose of this trial?

This study is a multi-center, randomized, partially double-blind, and placebo-controlled Phase Ib clinical trial of inhaled CO (iCO) for the treatment of sepsis-induced acute respiratory distress syndrome (ARDS). The purpose of this study is to evaluate the safety and accuracy of a Coburn-Forster-Kane (CFK) equation-based personalized iCO dosing algorithm to achieve a target carboxyhemoglobin (COHb) level of 6-8% in patients with sepsis-induced ARDS. We will also examine the biologic readouts of low dose iCO therapy in patients with sepsis-induced ARDS.

Research Team

Rebecca Baron, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

Adults with sepsis-induced ARDS, meeting specific criteria including a PaO2/FiO2 ratio ≤ 300 and requiring positive pressure ventilation. Excluded are those under 18, pregnant or breastfeeding women, patients without arterial/central lines, those not expected to survive 24 hours, and others with certain medical conditions.

Inclusion Criteria

I have sepsis with organ dysfunction due to an infection.

I have severe lung condition not caused by heart failure, needing a ventilator.

Your Sequential Organ Failure Assessment (SOFA) score has increased by 2 or more from the starting point.

Exclusion Criteria

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

You are a Jehovah's Witness or cannot or do not want to receive a blood transfusion while in the hospital.

I do not have severe heart, lung conditions, recent major surgeries, or participated in another drug study recently.

Treatment Details

Interventions

• Inhaled Carbon Monoxide (Gasotransmitter)

Trial Overview The trial tests personalized doses of inhaled Carbon Monoxide (200-500 ppm) to achieve COHb levels of 6-8% against inhaled medical air for safety and effectiveness in treating sepsis-induced ARDS. It's randomized and partially double-blind.

Participant Groups

Group I: Inhaled Carbon Monoxide Experimental Treatment 1 Intervention

Inhaled Carbon Monoxide at CFK equation-determined personalized dose (200-500 ppm to achieve a COHb level of 6-8%) 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

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

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

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

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