RecruitingEarly Phase 1NCT06950294

iNO300 Therapy in Critically Ill Patients With Pneumonia

High Dose Inhaled Nitric Oxide Therapy in Critically Ill Patients With Pneumonia: a Pilot, Double-blinded, Randomized, Controlled Trial

Sponsor

Massachusetts General Hospital

Enrollment

34 participants

Start Date

Feb 23, 2026

Study Type

INTERVENTIONAL

Conditions

Pneumonia Critical Illness

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria10

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

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGHigh dose inhaled nitric oxide

Inhaled nitric oxide starting at 250-300 ppm, 40min, every 6 hours, from day 1 to day 5. Nitric oxide is delivered using a gas cylinder containing nitric oxide and nitrogen.

OTHERSham treatment

Sham intervention with the nitric oxide gas cylinder replaced by that containing only nitrogen and all other delivery procedures identical to the intervention group

OTHERstandard therapy

Standard therapy pneumonia and critical illness