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

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