Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- Signed informed consent
- At least 18 years old
- Symptoms of shortness of breath within previous 8 days prior to screening
- Subjects must have:
- proven or high suspicion of SARS-CoV-2 infection and,
- O2 saturation < 92% on room air, and
- require supplemental O2 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
- 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
- History or clinical evidence of heart failure, left ventricular dysfunction (LVEF <40%)
- Subjects reporting hemoptysis