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iNO300 Therapy for Critically Ill Pneumonia Patients

This study is looking at how a high dose of inhaled nitric oxide (iNO) affects severely ill patients with pneumonia. Inhaled nitric oxide is a gas you breathe in. Researchers want to see how much of a substance called methemoglobin (MetHb) forms in the blood during iNO treatment and if this treatment helps patients recover from pneumonia. You might be able to join if you are 18 or older, have a new diagnosis of pneumonia, are very sick, and need a breathing machine. The study is comparing inhaled nitric oxide to a sham treatment (a treatment that looks real but has no active ingredient) and standard care. The study is currently unclear on its recruitment status.

Study design
This is a pilot, double-blinded, randomized controlled trial involving 34 adult patients. Participants will be randomly assigned to receive either inhaled nitric oxide or a sham treatment, in addition to standard care.
What's involved
If you join, you would receive either high dose inhaled nitric oxide or a sham treatment for 40 minutes, four times a day, for 5 days. Both groups will also receive standard pneumonia and critical illness therapy.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a total of 60 days after treatment to monitor methemoglobin levels and recovery.

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NCT06950294

iNO300 Therapy in Critically Ill Patients With Pneumonia

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Massachusetts General Hospital
~34 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:High dose inhaled nitric oxideSham treatmentstandard therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peaks of methomoglobin
Measured over From Day 1 to Day 5

Conditions

Critical Illness
Pneumonia

Explore related trials

Critical IllnessPneumonia

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Lorenzo Berra, MD · PRINCIPAL_INVESTIGATOR · Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital

Who to contact

Lorenzo Berra, MD
[email protected]
617-726-3030
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Peaks of methomoglobinFrom Day 1 to Day 5

    Continuous recording of MetHb and peaks of MetHb will be determined.