Phase 2
N=200
Nitric Oxide Gas Inhalation in Severe Acute Respiratory Syndrome in COVID-19
SARS (Severe Acute Respiratory Syndrome) · Coronavirus
Bottom Line
View on ClinicalTrials.gov: NCT04306393 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Change of Arterial Oxygenation at 48 Hours From Enrollment — 200; 183 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nitric Oxide Gas (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Arterial Oxygenation at 48 Hours From Enrollment |
200; 183 | — |
| SECONDARY Time to Reach Normoxemia During the First 28 Days After Enrollment |
8.7; 8.4 | — |
| SECONDARY Proportion of SARS-nCoV-2 Free Patients During the First 28 Days After Enrollment |
33; 21 | — |
| SECONDARY Survival at 28 Days From Enrollment |
67; 72 | — |
| SECONDARY Survival at 90 Days From Enrollment |
62; 67 | — |
Summary
Severe acute respiratory syndrome (SARS-CoV2) due to novel Coronavirus (2019-nCoV) related infection (COVID-19) is characterized by severe ventilation perfusion mismatch leading to refractory hypoxemia. To date, there is no specific treatment available for 2019-nCoV. Nitric oxide is a selective pulmonary vasodilator gas used in as a rescue therapy in refractory hypoxemia due to acute respiratory distress syndrome (ARDS). In-vitro and clinical evidence indicate that inhaled nitric oxide gas (iNO) has also antiviral activity against other strains of coronavirus. The primary aim of this study is to determine whether inhaled NO improves oxygenation in patients with hypoxic SARS-CoV2. This is a multicenter single-blinded randomized controlled trial with 1:1 individual allocation
Eligibility Criteria
Inclusion criteria: (1) Adult patients, >/= 18 year-old; (2) Patients admitted to the ICU; (3) Patients who are intubated and mechanically ventilated; (4) Confirmed diagnosis of SARS-CoV2 by positive rt-PCR.
Exclusion criteria: (1) Patients intubated for more than 72 hours from initiation of the treatment gas; (2) Subjects enrolled in another interventional research study; (3) Physician of record opposed to enrolling the patient due to perceived safety concerns; or any condition that does not allow the protocol to be followed safely; (4) Subjects with past medical history of lung malignancy or pneumonectomy or lung transplant; (5) Subjects receiving a tidal volume 50%; (12) Subjects not fully committed to full support at the time of enrollment; (13) Subject receiving inhaled nitric oxide gas prior to enrollment; (14) Subject's hospital admission unrelated to COVID-19.
Data sourced from ClinicalTrials.gov (NCT04306393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.