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Trial · NCT06950294

iNO300 Therapy in Critically Ill Patients With Pneumonia

NCT06950294, Early phase 1, Recruiting, Massachusetts General Hospital

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. iNO300 Therapy in Critically Ill Patients With Pneumonia. Trials, record NCT06950294. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06950294

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
iNO300 Therapy in Critically Ill Patients With Pneumonia
NCT number
NCT06950294
Status
Recruiting
Phases
Early phase 1
Enrollment
34 participants, estimated
Lead sponsor
Massachusetts General Hospital
Conditions
Critical Illness, Pneumonia
Interventions
High dose inhaled nitric oxide, Sham treatment, standard therapy
First posted
2025-04-30
Last updated
2026-05-22

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPeaks of methomoglobinFrom Day 1 to Day 5Continuous recording of MetHb and peaks of MetHb will be determined.
SecondaryNitrogen dioxide levelFrom Day 1 to Day 5Continuous measurement of nitrogen dioxide concentration in the inspiratory limb of breathing circuit
SecondaryFeasibilityFrom enrollment to Day 60Referral, recruitment, retention, compliance and follow-up completion rates of the study
SecondaryClinical cure rate of pneumoniaFrom enrollment to test of cure day (4 -11 days post end of treatment)
Clinical cure is assessed at test of cure (4 -11 days post end of treatment) and defined as resolution of clinical signs and symptoms of pneumonia compared with baseline, including a reduction in SOFA and CPIS scores, improvement or lack of progression in chest imaging, and no requirement for additional antibacterial treatment.
SecondaryClinical improvement rate of pneumoniaDay 5
Clinical improvement is assessed at end of treatment and defined as improvement in 2 or more clinical signs and symptoms of pneumonia compared with baseline, improvement or lack of progression of chest x-ray abnormalities, and no requirement for additional antibacterial treatment. Clinical signs and symptoms of pneumonia include new onset or worsening cough, purulent sputum or increased suction requirements, auscultation findings of pneumonia, dyspnea, tachypnea, or respiratory rate ≥ 30/min, hypoxemia, worsening gas exchange.
SecondaryMicrobiologic eradication rateFrom enrollment to test of cure day (4 -11 days post end of treatment)
Absence of the baseline pathogen from tracheal aspiration or bronchoalveolar lavage fluid will be confirmed. If it is not possible to obtain an appropriate clinical specimen for culture and the patient has a successful clinical outcome, the response was presumed to be eradication.
Secondary28-day all cause mortalityFrom enrollment to Day 28All cause mortality from enrollment to Day 28
Secondary60-day all cause mortalityFrom enrollment to Day 60All cause mortality from enrollment to Day 60
Secondary28-day ventilator free daysFrom enrollment to Day 28
Successful liberation from mechanical ventilation should last more than 48 h without re-intubation in patients who have survived 28 days after randomization (extubation was counted from the last successful attempt in patients who have survived 28 days since randomization) and for patients ventilated for 28 days or more or who died before 28 days (irrespective of intubation status), the number of ventilator-free days was recorded at zero.
SecondaryDays free from organ support in 28 daysFrom enrollment to Day 28Organ support includes mechanical ventilation, vasopressors and renal replacement therapy.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers10

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
22520076BACKGROUNDPubMed
29178284BACKGROUNDPubMed
32685229BACKGROUNDPubMed
33225304BACKGROUNDPubMed
33352464BACKGROUNDPubMed
34400339BACKGROUNDPubMed
35623183BACKGROUNDPubMed
35852269BACKGROUNDPubMed
39060420BACKGROUNDPubMed
39793728BACKGROUNDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06950294

GET https://conductscience.org/api/trials/v1/NCT06950294/registered