iNOPulse for COVID-19
NCT04398290 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2020-08-19
Summary
This randomized, controlled trial will assess the efficacy and safety of pulsed iNO in subjects with COVID-19 who are hospitalized and require supplemental oxygen.
Conditions
- COVID-19
- Hypoxemia
- Hypoxemic Respiratory Failure
Interventions
- DRUG
-
Inhaled nitric oxide (iNO)
iNO Pulse 250 mcg/kg ideal body weight (IBW)/hour
- DRUG
-
Nitrogen gas
250 mcg/kg ideal body weight (IBW)/hour
- DRUG
-
Oxygen gas
Supplemental oxygen administered via nasal cannula
Sponsors & Collaborators
-
Bellerophon Therapeutics
collaborator UNKNOWN -
Roger Alvarez
lead OTHER
Principal Investigators
-
Roger A Alvarez, D.O. · University of Miami
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-01
- Primary Completion
- 2021-06-01
- Completion
- 2021-07-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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