High Dose Inhaled Nitric Oxide for COVID-19 (ICU Patients)
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Nitric Oxide
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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
- 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
Sites / Locations
- University Health Network, Toronto General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care (control)
Inhaled Nitric Oxide
Arm Description
Patients will receive standard of care therapy
Outcomes
Primary Outcome Measures
COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate
Secondary Outcome Measures
Full Information
NCT ID
NCT04383002
First Posted
May 1, 2020
Last Updated
April 7, 2022
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04383002
Brief Title
High Dose Inhaled Nitric Oxide for COVID-19 (ICU Patients)
Official Title
Use of High Dose Inhaled Nitric Oxide in Intubated Patients Admitted With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
May 11, 2021 (Actual)
Study Completion Date
June 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care (control)
Arm Type
No Intervention
Arm Description
Patients will receive standard of care therapy
Arm Title
Inhaled Nitric Oxide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nitric Oxide
Intervention Description
iNO will be given at 160ppm for 6 hours, once a day, for 2 days
Primary Outcome Measure Information:
Title
COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Cypel, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network, Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
High Dose Inhaled Nitric Oxide for COVID-19 (ICU Patients)
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