iNO300 Therapy in Critically Ill Patients With Pneumonia

Phase

Condition

Pneumonia

Treatment

standard therapy

High dose inhaled nitric oxide

Sham treatment

Clinical Study ID

NCT06950294

2025P000909

Ages > 18
All Genders

Study 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

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 authorizedrepresentatives

Exclusion

Exclusion Criteria:

Baseline methemoglobin 3% or higher
Genetic diseases including glucose-6-phosphate dehydrogenase deficiency, cytochromeb5 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 ejectionfraction less than 20%
Receiving inhaled NO therapy or decision to initiate inhaled NO therapy within 24hours 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

Study Design

standard therapy

February 23, 2026

December 31, 2026

Study Description

This study is designed as a pilot, double-blinded, randomized controlled trial to investigate levels of methemoglobin in the treatment group versus the control group and efficacy of high dose inhaled NO among critically ill patients with pneumonia. We will enroll 34 adult patients with newly diagnosed pneumonia and invasive mechanical ventilation who are admitted to the ICUs at Massachusetts General Hospital.

After enrollment, participants will be randomized in 1:1 ratio to intervention group or control group. Baseline characteristics will be collected.

During treatment period, patients allocated to the intervention group will receive high dose inhaled NO starting at 250 ppm (not exceeding 300 ppm), 40min, 4 times daily, for 5 days. The control group will receive sham intervention. Both groups will receive standard therapy.

During follow-up period, we will follow participants for a total duration of 60 days. Methemoglobin kinetic levels and efficacy outcomes will be collected.

Connect with a study center

Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Active - Recruiting

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