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

NCT04383002 | Completed Phase 1 DMC

• 1 other identifier: 20-5449
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate

  7 days

Study Arms (2)

Standard of Care (control)

NO INTERVENTION

Patients will receive standard of care therapy

Inhaled Nitric Oxide

EXPERIMENTAL

Drug: Nitric Oxide

Interventions

Nitric Oxide DRUG

iNO will be given at 160ppm for 6 hours, once a day, for 2 days

Inhaled Nitric Oxide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

COVID-19

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Marcelo Cypel, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 11, 2020
• Study Start: September 2, 2020
• Primary Completion: May 11, 2021
• Study Completion: June 11, 2021
• Last Updated: April 11, 2022

Record last verified: 2021-05

Locations

CA (1)