Inhaled Carbon Monoxide for ARDS

Recruiting at 5 trial locations

Overseen By Mark A Perrella, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Brigham and Women's Hospital

Must not be taking: Inhaled vasodilators

Disqualifiers: Pregnancy, Severe cardiopulmonary disease, Stroke, others

Compensation: Varies

Number of Visits: 7

Duration: 3 days

5 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using inhaled pulmonary vasodilator therapy like nitric oxide or prostaglandins, you may not be eligible to participate.

Is inhaled carbon monoxide generally safe for humans?

Research suggests that low-dose inhaled carbon monoxide might have protective effects in certain conditions like sepsis-induced ARDS and COPD, but its safety in humans is not fully established. While some studies indicate potential benefits, the effects and safety of inhaled carbon monoxide in humans need more investigation. ^{1 2 3 4 5}

How is the treatment of inhaled carbon monoxide unique for ARDS?

Inhaled carbon monoxide is a novel treatment for acute respiratory distress syndrome (ARDS) because it is administered as a gas through inhalation, and it works by potentially reducing inflammation and promoting healing in the lungs. Unlike other treatments, it is still under investigation and aims to provide a pharmacologic option where none currently exist. ^{1 6 7 8 9}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive inhaled carbon monoxide or placebo for up to 90 minutes daily for 3 days

3 days

Daily visits for 3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

Regular assessments on days 1-5, 7, 14, and 28

Long-term Follow-up

Participants are assessed for cognitive and other long-term outcomes

3-6 months

Telephone interviews at 3 and 6 months

Treatment Details

Interventions

• Inhaled Carbon Monoxide

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+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

A phase I trial of low-dose inhaled carbon monoxide in sepsis-induced ARDS. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Ambient carbon monoxide and the risk of hospitalization due to chronic obstructive pulmonary disease. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[Changes of carbon monoxide, nitric oxide levels and heme oxygenase system in acute respiratory distress syndrome induced by oleic acid]. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of inhaled carbon monoxide on acute lung injury in mice. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Anesthesia-Related Carbon Monoxide Exposure: Toxicity and Potential Therapy. [2018]

6. Italy pubmed.ncbi.nlm.nih.gov

[Nitric oxide inhalation test in patients with ARDS: preliminary assessment of the effect on arterial oxygenation]. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Endogenous Carbon Monoxide Production and Diffusing Capacity of the Lung for Carbon Monoxide in Sepsis-Induced Acute Respiratory Distress Syndrome. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of inhaled CO administration on acute lung injury in baboons with pneumococcal pneumonia. [2020]

9. Denmark pubmed.ncbi.nlm.nih.gov

Can carbon monoxide be absorbed from the upper respiratory tract in man? [2015]