A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19

Inclusion Criteria:

- Signed informed consent

- At least 18 years old

- Subjects must be hospitalized and have the following:

- proven or high suspicion of SARS-CoV-2 infection and,

- requiring oxygen supplementation defined as:

- SpO2 ≤ 92% regardless of supplemental oxygen (ie on room air or on oxygen), or

- SpO2 ≥ 92% on supplemental O2 and in the opinion of the Investigator it is not
safe to decrease or remove the supplemental oxygen

- require supplemental oxygen of no more than 10 L/minute, and

- radiologic suspected or proven COVID-19 pneumonitis (chest x-ray or CT scan)

- Female subjects must have a negative pregnancy test

- Willing and able to comply with the treatment schedule and study procedures

Exclusion Criteria:

- Participating in another clinical trial of an investigational treatment for COVID-19

- Methemoglobin > 3%

- Evidence of severe multi organ failure

- Use of assisted ventilation prior to initiation of iNO

- Pregnancy or positive pregnancy test pre-dose

- Open tracheostomy

- Chronic use of a nitric oxide donor agent such as nitroglycerin or drugs known to
increase methemoglobin such as lidocaine, prilocaine, benzocaine, nitroprusside,
isosorbide, or dapsone at screening

- History or clinical evidence of systolic heart failure, left ventricular dysfunction
(LVEF <40%)

- Subjects reporting massive hemoptysis associated with the current illness or with
radiologically proven pulmonary embolus