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.
Drug: Nitric Oxide
iNO will be given at 160ppm for 6 hours, once a day, for 2 days
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
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada
Marcelo Cypel, MD, Principal Investigator
University Health Network, Toronto