Pulsed, inhaled nitric oxide (iNO) for the treatment of patients with mild ormoderate corona virus disease (COVID-19)

Phase 1

• Conditions: Corona virus disease; MedDRA version: 23.0Level: LLTClassification code 10084355Term: COVID-19 virus test positiveSystem Organ Class: 100000004848; MedDRA version: 23.0Level: LLTClassification code 10084383Term: Novel COVID-19-infected pneumoniaSystem Organ Class: 100000004862; MedDRA version: 23.0Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-002394-94-BE
• Lead Sponsor: Dr. De Backer Wilfried BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-04
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 6

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

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

Study & Design

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