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High Dose Inhaled Nitric Oxide for COVID-19 (ICU Patients)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04383002
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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
COVID-19 Drug: Nitric Oxide Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of High Dose Inhaled Nitric Oxide in Intubated Patients Admitted With COVID-19
Actual Study Start Date : September 2, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard of Care (control)
Patients will receive standard of care therapy
Experimental: Inhaled Nitric Oxide Drug: Nitric Oxide
iNO will be given at 160ppm for 6 hours, once a day, for 2 days




Primary Outcome Measures :
  1. COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate [ Time Frame: 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed infection with COVID-19 positive RT-PCR tracheal aspirate prior to treatment
  2. Use of mechanical ventilation with or without ECMO
  3. Male or female ages > 18 years
  4. < 14 days from symptom initiation to study enrolment and < 7 days from intubation to study enrolment

Exclusion Criteria:

  1. Patients on other interventional clinical trials
  2. 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
  3. Subjects diagnosed with immunodeficiency
  4. Hematology: patients with clinically significant anemia e.g. Hemoglobin < 100 and thrombocytopenia e.g. Platelets < 75
  5. Subjects with clinically significant history of, or active bleeding including active pulmonary or gastrointestinal bleeding
  6. 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
  7. 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
  8. Pregnancy
  9. Subjects with a known hypersensitivity to methylene blue, subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency
  10. Known or suspected thalassemia, sickle cell disease, or other conditions associated with poor oxygen carrying capacity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04383002


Contacts
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Contact: Jennifer Lister 416-340-4857 Jennifer.Lister@uhn.ca

Locations
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Canada, Ontario
University Health Network, Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Jennifer Lister, BSc CCRP    416-340-4857    Jennifer.Lister@uhn.ca   
Principal Investigator: Marcelo Cypel, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Marcelo Cypel, MD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04383002    
Other Study ID Numbers: 20-5449
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents