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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Respiratory Distress Syndrome

In brief

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

Key facts

Study ID

NCT03799874

Run by

Brigham and Women's Hospital

People needed

4

Starts

2019-09-30

Expected to finish

2021-04-13

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• Bilateral opacities on frontal chest radiograph (not fully explained by effusions, lobar/lung collapse, or nodules) within 1 week of a known clinical insult or new or worsening respiratory symptoms
• A need for positive pressure ventilation by an endotracheal or tracheal tube
• Respiratory failure not fully explained by cardiac failure or fluid overload; need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present.
• ARDS onset is defined as the time the last of criteria 1-4 are met. ARDS must persist through the enrollment time window of 168 hours.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Age less than 18 years
• Greater than 168 hours since ARDS onset
• Pregnant or breastfeeding
• Prisoner
• Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
• No consent/inability to obtain consent or appropriate legal representative not available
• Physician refusal to allow enrollment in the trial
• Moribund patient not expected to survive 24 hours
• No arterial or central line/no intent to place an arterial or central line
• No intent/unwillingness to follow lung protective ventilation strategy
• Severe hypoxemia defined as SpO2 < 95 or PaO2 < 90 on FiO2 ≥ 0.9
• Hemoglobin < 7.0 g/dL
• Subjects who are Jehovah's Witnesses or are otherwise unable or unwilling to receive blood transfusions during hospitalization
• Acute myocardial infarction (MI) or acute coronary syndrome (ACS) within the last 90 days
• Coronary artery bypass graft (CABG) surgery within 30 days
• Angina pectoris or use of nitrates with activities of daily living
• Cardiopulmonary disease classified as NYHA class IV
• Stroke (ischemic or hemorrhagic) within the prior 1 month, cardiac arrest requiring CPR within the prior 72 hours, or inability to assess mental status following cardiac arrest
• Burns > 40% total body surface area (TBSA)
• Severe airway inhalational injury
• Use of high frequency oscillatory ventilation
• Use of extracorporeal membrane oxygenation (ECMO)
• Concomitant use of inhaled pulmonary vasodilator therapy (eg. nitric oxide [NO] or prostaglandins)
• Diffuse alveolar hemorrhage from vasculitis

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• New York-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Duke Regional Hospital — Durham, North Carolina, United States
• Duke University Hospital — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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