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

Phase 1

• Conditions: ARDS caused by COVID-19 infection; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001329-30-AT
• Lead Sponsor: Massachussetts General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-03
• Last Update Posted: 29 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

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 < 300 mmHg.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the rate of change in oxygenation <br><br>;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.<br><br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): Time to reach normoxia for at least 24 hours, defined by a PaO2/FiO2> 300 mmHg<br>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