NCT04383002
Completed
Phase 1
Use of High Dose Inhaled Nitric Oxide in Intubated Patients Admitted With COVID-19
University Health Network, Toronto1 site in 1 country21 target enrollmentStarted: September 2, 2020Last updated:
Overview
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate
Overview
Brief Summary
Novel therapies are desperately needed for treatment of COVID-19 patients. At present, there are no proven interventions to prevent progression of the disease or to rapidly treat patients with COVID-19 related respiratory failure. Data on the original coronavirus -SARS pneumonia suggested that high dose (>160ppm) inhaled Nitric Oxide could have beneficial effects also on COVID-19, due to the genomic similarities between these two coronaviruses (1-3). This study will test whether high dose inhaled nitric oxide is safe and can reverse virus burden and respiratory failure in patients on mechanical ventilation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed infection with COVID-19 positive RT-PCR tracheal aspirate prior to treatment
- •Use of mechanical ventilation with or without ECMO
- •Male or female ages \> 18 years
- •\< 14 days from symptom initiation to study enrolment and \< 7 days from intubation to study enrolment
Exclusion Criteria
- •Patients on other interventional clinical trials
- •Subjects diagnosed with congestive or unstable heart disease including heart failure, left ventricular dysfunction (LVEF \< 40 %) or myocardial damage, severe pulmonary hypertension and/or unstable hypertension
- •Subjects diagnosed with immunodeficiency
- •Hematology: patients with clinically significant anemia e.g. Hemoglobin \< 100 and thrombocytopenia e.g. Platelets \< 75
- •Subjects with clinically significant history of, or active bleeding including active pulmonary or gastrointestinal bleeding
- •Hepatic Function: Patients with abnormal liver function defined as any two of the following ALT \>3x ULN, AST \>3x ULN, Total bilirubin \< 1.5 X ULN
- •Patient receiving drugs that have a contraindication with NO e.g. 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 as relevant to the proposed study population
- •Subjects with a known hypersensitivity to methylene blue, subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Known or suspected thalassemia, sickle cell disease, or other conditions associated with poor oxygen carrying capacity
Arms & Interventions
Inhaled Nitric Oxide
Experimental
Intervention: Nitric Oxide (Drug)
Outcomes
Primary Outcomes
COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate
Time Frame: 7 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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