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Phase 2 N=200 Randomized Single-blind Treatment

Nitric Oxide Gas Inhalation in Severe Acute Respiratory Syndrome in COVID-19

SARS (Severe Acute Respiratory Syndrome) · Coronavirus

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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