Corona virus disease MedDRA version: 23.0 Level: LLT Classification code 10084355 Term: COVID-19 virus test positive System Organ Class: 100000004848 MedDRA version: 23.0 Level: LLT Classification code 10084383 Term: Novel COVID-19-infected pneumonia System Organ Class: 100000004862 MedDRA version: 23.0 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: iNO
Pharmaceutical Form: Pressurised inhalation
Sponsors
Dr. De Backer Wilfried BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments. 2. At least 18 years old 3. Hospitalized patients with proven or high suspicion of SARS-CoV-2 infection and on supplemental oxygen >2 L/minute and = 10 L/minute 4. Suspected or proven pneumonia on chest imaging 5. Female patients of childbearing potential must have a negative pretreatment pregnancy test (serum or urine). All female patients should take adequate precaution to avoid pregnancy. 6. Willing and able to comply with treatment schedule and study procedures. 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 3 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1. Participating in any other clinical trial of an experimental treatment for COVID-19 2. Gas exchange and ventilation requiring the use of any continuous positive airway pressure (CPAP), or any system of Non Invasive Ventilation (NIV), with Positive End-Expiratory Pressure (PEEP) = 10 cmH2O prior to initiation of iNO 3. Pregnancy, or positive pregnancy test in a pre-dose examination 4. Open tracheostomy 5. Clinical contra-indication, as deemed by the attending physician including chronic lung disease 6. Use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as lidocaine, prilocaine, benzocaine or dapsone at screening 7. Known history or clinical evidence of heart failure, left ventricular dysfunction (LVEF < 40 %) 8. Patients reporting hemoptysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to examine the utility of high resolution computed tomography (HRCT) to measure changes in functional pulmonary imaging parameters as a function of iNO administration using the device INOpulse in relation to the corona virus disease. Changes from baseling to at least 5 minutes of iNO and after 5 days using iNO 8 to 24 h/day. Clinical evaluation of INOpulse for patients with COVID-19 using clinical and imaging endpoints;Secondary Objective: Not applicable;Primary end point(s): Clinical evaluation of INOpulse for patients with COVID-19 using clinical 1. Death 2. Hospitalized, requiring mechanical ventilation or ECMO 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - not requiring ongoing medical care (COVID-19 related or otherwise) 7. Not hospitalized - limitation on activities and/or requiring home oxygen 8. Not hospitalized, no limitations on activities;Timepoint(s) of evaluation of this end point: Assessed at the start of iNOpulse treatment,during treatment, upon completion of treatment and at follow up (Day 28). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following CT derived anatomical and functional parameters should be reported based on the initial CT’s taken before and during iNO inhalation: imaged airway volume (iVaw), imaged airway resistance (iRaw), blood vessels volumes for different sized vessels (<5 mm2, between 5-10 mm2, larger than 10 mm2);Timepoint(s) of evaluation of this end point: At baseline, after at least 5 minutes and after 5 daysof iNO (using 8 to 24 h/day) | — |
Countries
Belgium
Contacts
Public ContactClinical Trial Information Desk
Dr. De Backer Wilfried BV
Outcome results
None listed