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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. Read our disclaimer for details. Identifier: NCT04383002
Recruitment Status : Completed
First Posted : May 11, 2020
Last Update Posted : April 11, 2022
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)
Actual Enrollment : 21 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
Actual Primary Completion Date : May 11, 2021
Actual Study Completion Date : June 11, 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT04383002

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Canada, Ontario
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Marcelo Cypel, MD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto Identifier: NCT04383002    
Other Study ID Numbers: 20-5449
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: May 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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Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents