Therapy with Inhaled Nitric Oxide for Patients Infected with Coronavirus Suffering form Lung Failure

Inhaled Nitric Oxide Gas Therapy in Mechanically Ventilated Patients with Severe Acute Respiratory Syndrome in COVID-19 - NOSARSCOVID19

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001329-30-AT

Enrollment

200

Registered

2020-04-03

Start date

2020-04-09

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS caused by COVID-19 infection

Interventions

Product Name: Inhaled nitric oxide Product Code: n.a. Pharmaceutical Form: Inhalation solution INN or Proposed INN: NITRIC OXIDE CAS Number: 10102-43-9 Other descriptive name: Nitrogen monoxide Conce

Eligibility

Sex/Gender

All

Inclusion 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; 5. Severe hypoxemia, defined by PaO2/FiO2 =65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: 1. Patients intubated for more than 72 hours from initiation of the treatment gas 2. 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the rate of change in oxygenation ;Secondary Objective: To assess an improvement in survival, organ damage and weaning from mechanical ventilation in SARS-CoV-2 patients. This would indicate an effect that cannot be addressed only the amelioration of V/Q mismatching in the course of a disease characterized by pneumonia and, in most severe cases, multiorgan failure. To assess the time at which a patient is negative for SARS-CoV2, reflective of a possible antiviral effect.;Primary end point(s): Difference in oxygenation between the two groups;Timepoint(s) of evaluation of this end point: 48 hours	—

Measure

Time frame

Main Objective: To assess the rate of change in oxygenation ;Secondary Objective: To assess an improvement in survival, organ damage and weaning from mechanical ventilation in SARS-CoV-2 patients. This would indicate an effect that cannot be addressed only the amelioration of V/Q mismatching in the course of a disease characterized by pneumonia and, in most severe cases, multiorgan failure. To assess the time at which a patient is negative for SARS-CoV2, reflective of a possible antiviral effect.;Primary end point(s): Difference in oxygenation between the two groups;Timepoint(s) of evaluation of this end point: 48 hours

—

Secondary

Measure	Time frame
Secondary end point(s): Time to reach normoxia for at least 24 hours, defined by a PaO2/FiO2> 300 mmHg Proportion of normoxemic patients in the two groups during the first 28 days after enrollment. 3. Survival at 28 days and 90 days from enrollment.;Timepoint(s) of evaluation of this end point: 28 and 90 days	—

Countries

Austria, China, United States

Contacts

Public ContactClinical Research Division

Massachussetts General Hospital

0016177269252

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026