NCT06950294 iNO300 Therapy in Critically Ill Patients With Pneumonia
| NCT ID | NCT06950294 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Massachusetts General Hospital |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2026-02-23 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 34 participants in total. It began in 2026-02-23 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn the formation and recovery rate of methemoglobin (MetHb) in severely sick patients with pneumonia who receive high doses of inhaled nitric oxide (iNO) therapy at 250 parts per million (ppm), not exceeding 300 ppm. Meanwhile, the benefits of the therapy to treat severely sick patients with pneumonia will be explored. Patients who are 18 years or older, newly diagnosed with pneumonia, and severely sick with requirement of a breathing machine could be included. The main questions it aims to answer are: How does methemoglobin change through the iNO treatment? Does iNO therapy increase the number of patients recovering from pneumonia? Researchers will compare iNO treatment to placebo, which means using the same device as the treatment group without delivering the study drug. Participants will: * Receive iNO treatment starting at 250 ppm, not exceeding 300 ppm, 40 min, every 6 hours, from day 1 to day 5 * Be followed up for 60 days
Eligibility Criteria
Inclusion Criteria: * 18 years or older * Intubated and mechanically ventilated * Within 72h of diagnosis of community- or hospital-acquired pneumonia * Written informed consent obtained from patients or legally authorized representatives Exclusion Criteria: * Baseline methemoglobin 3% or higher * Genetic diseases including glucose-6-phosphate dehydrogenase deficiency, cytochrome b5 reductase deficiency, sickle cell disease * Oxygen saturation \< 88% on 100% inspired fraction of oxygen * Anemia with hemoglobin \< 7.0 g/dl * Acute cardiogenic shock requiring inotropic or mechanical support with an ejection fraction less than 20% * Receiving inhaled NO therapy or decision to initiate inhaled NO therapy within 24 hours post randomization * A decision to do-not-resuscitate (DNR) * Enrollment in another experimental antimicrobial treatment protocol * Patients for whom follow-up is expected to be impossible
Contact & Investigator
Lorenzo Berra, MD
PRINCIPAL INVESTIGATOR
Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT06950294 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06950294 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06950294 currently recruiting?
Yes, NCT06950294 is actively recruiting participants. Contact the research team at lberra@mgh.harvard.edu for enrollment information.
Where is the NCT06950294 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06950294 clinical trial?
NCT06950294 is sponsored by Massachusetts General Hospital. The principal investigator is Lorenzo Berra, MD at Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital. The trial plans to enroll 34 participants.