EUCTR2020-002394-94-BEActive, not recruitingPhase 1
Pulsed, inhaled nitric oxide (iNO) for the treatment of patients with mild ormoderate corona virus disease (COVID-19)
Dr. De Backer Wilfried BV0 sites6 target enrollmentStarted: June 4, 2020Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 6
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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