High Dose Inhaled Nitric Oxide for COVID-19 (ICU Patients)
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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No Intervention: Standard of Care (control) Patients will receive standard of care therapy |
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Experimental: Inhaled Nitric Oxide
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Drug: Nitric Oxide
iNO will be given at 160ppm for 6 hours, once a day, for 2 days
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Outcome Measures
Primary Outcome Measures
- COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate [7 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Confirmed infection with COVID-19 positive RT-PCR tracheal aspirate prior to treatment
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Use of mechanical ventilation with or without ECMO
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Male or female ages > 18 years
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< 14 days from symptom initiation to study enrolment and < 7 days from intubation to study enrolment
Exclusion Criteria:
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Patients on other interventional clinical trials
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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
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Subjects diagnosed with immunodeficiency
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Hematology: patients with clinically significant anemia e.g. Hemoglobin < 100 and thrombocytopenia e.g. Platelets < 75
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Subjects with clinically significant history of, or active bleeding including active pulmonary or gastrointestinal bleeding
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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
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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
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Pregnancy
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Subjects with a known hypersensitivity to methylene blue, subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency
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Known or suspected thalassemia, sickle cell disease, or other conditions associated with poor oxygen carrying capacity
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University Health Network, Toronto General Hospital | Toronto | Ontario | Canada | M5G 2C4 |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
- Principal Investigator: Marcelo Cypel, MD, University Health Network, Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-5449