Status:
COMPLETED
High Dose Inhaled Nitric Oxide for COVID-19 (ICU Patients)
Lead Sponsor:
University Health Network, Toronto
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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-1...
Eligibility Criteria
Inclusion
- 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
- 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
- Pregnancy
- 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
Key Trial Info
Start Date :
September 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04383002
Start Date
September 2 2020
End Date
June 11 2021
Last Update
April 11 2022
Active Locations (1)
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1
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4