Recruiting
Early Phase 1

iNO

Sponsor:

Massachusetts General Hospital

Code:

NCT06950294

Conditions

Critical Illness

Pneumonia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High dose inhaled nitric oxide

Sham treatment

standard therapy

Study Details

Brief 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

Conditions

Critical Illness

Pneumonia

Study ID

NCT06950294

Start date

Feb 23, 2026

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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%
  • 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

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: iNO300 group

High dose inhaled nitric oxide starting at 250 ppm (not exceeding 300 ppm) , 40min, 4 times daily, from day 1 to day 5. Nitric oxide is delivered using a gas cylinder containing nitric oxide and nitrogen.

sham comparator: Control group

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

Interventions

High 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.

Sham 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

standard therapy

Standard therapy pneumonia and critical illness

Primary outcome measure

  • Peaks of methomoglobin [ Time Frame: From Day 1 to Day 5 ]

Central Contacts and Locations

Central contacts

Lorenzo Berra, MD

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

Run Dong, MD

617-726-3030rdong2@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Run Dong

6172563916rdong2@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • High dose inhaled nitric oxide
  • Pneumonia
  • Critical care
  • Methemoglobin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-22.