RecruitingEarly Phase 1

iNO300 Therapy in Critically Ill Patients With Pneumonia

United States34 participantsStarted 2026-02-23

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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% * eGFR \< 30 ml/min/1.73m2 or use of continuous renal replacement therapy * 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

What they're measuring

Peaks of methomoglobin

Timeframe: From Day 1 to Day 5

Trial details

NCT IDNCT06950294

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Lorenzo Berra, MD

617-726-3030 lberra@mgh.harvard.edu