High Dose Inhaled Nitric Oxide for COVID-19 (ICU Patients)
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ClinicalTrials.gov Identifier: NCT04383002 |
Recruitment Status :
Completed
First Posted : May 11, 2020
Last Update Posted : April 11, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: Nitric Oxide | Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
No Intervention: Standard of Care (control)
Patients will receive standard of care therapy
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Experimental: Inhaled Nitric Oxide |
Drug: Nitric Oxide
iNO will be given at 160ppm for 6 hours, once a day, for 2 days |
- COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate [ Time Frame: 7 days ]

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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:
- 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

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
Canada, Ontario | |
University Health Network, Toronto General Hospital | |
Toronto, Ontario, Canada, M5G 2C4 |
Principal Investigator: | Marcelo Cypel, MD | University Health Network, Toronto |
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 11, 2022 |
Last Verified: | May 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia 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 Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Gasotransmitters Protective Agents |