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

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo in Subjects With Mild or Moderate Coronavirus (COVID-19)

A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed inhaled iNO compared to placebo in subjects with COVID-19.

This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed iNO compared to placebo in subjects with COVID-19 who are hospitalized and require supplemental oxygen without assisted ventilation. Subjects will be randomized to receive placebo or iNO125 mcg/kg ideal body weight (IBW)/hour 24 hours daily up to 14 days or until resolution or discharge.

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