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Clinical Trials/EUCTR2020-002394-94-BE
EUCTR2020-002394-94-BE
Active, not recruiting
Phase 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 enrollmentJune 4, 2020
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Dr. De Backer Wilfried BV
Enrollment
6
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 4, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Dr. De Backer Wilfried BV

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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