Safety Study of Inhaled Carbon Monoxide to Treat Pneumonia and Sepsis-Induced Acute Respiratory D… (NCT04870125) | Clinical Trial Compass
TerminatedPhase 1
Safety Study of Inhaled Carbon Monoxide to Treat Pneumonia and Sepsis-Induced Acute Respiratory Distress Syndrome (ARDS)
Stopped: Due to low enrollment, the study was halted early.
United States5 participantsStarted 2023-12-06
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Suspected or proven infection: Sites of infection include thorax, urinary tract, abdomen, skin, sinuses, central venous catheters, and central nervous system
. Increase in Sequential Organ Failure Assessment (SOFA) Score ≥ 2 over baseline
. 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 is present
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — do you know why it was stopped, and what that means for whether inhaled carbon monoxide is still being studied as a treatment for ARDS?
2Since this was a Phase 1 safety study focused on tracking adverse events related to carbon monoxide inhalation, what is currently known about the risks of this approach, and are there any safety signals from this trial that would be relevant to my situation?
3The trial was measuring how precisely doctors could hit a target level of carboxyhemoglobin in the blood — what does it mean for a patient on a ventilator with ARDS if that level isn't controlled accurately?
4Given that this trial was terminated and involved an experimental gas therapy still in early safety testing, would a more established treatment pathway for sepsis-related ARDS make more sense for me right now?
5Are there any other active trials or follow-on studies exploring inhaled carbon monoxide for ARDS that I should know about, given that this one is no longer enrolling?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Safety Outcome: Number of Pre-specified Administration-related Adverse Events (AEs).
Timeframe: 7 days
2
Percentage Change Measured Relative to Target COHb Level
Timeframe: Post exposure 90 min day 1
3
Variance of Measured Relative to Target COHb Level
Timeframe: Post exposure 90 min day 2
4
Variance of Measured Relative to Target COHb Level
. 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