Clinical Trial

iNO300 Therapy in Critically Ill Patients With Pneumonia

Study acronym: iNO300
Recruiting Early Phase 1
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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
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-04-24; most recent amendment 2026-05-20.
Status change: Not Yet Recruiting → Recruiting 2026-03-02
Trial Details
NCT Number NCT06950294
Lead Sponsor Massachusetts General Hospital
Conditions Critical Illness, Pneumonia
Enrollment 34 participants
Start Date 2026-02-23
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-22