Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19

Inclusion criteria

• Male or non-pregnant female ≥ 18 years of age.
• Willing and able to provide written informed consent (or provided by a proxy).
• Currently hospitalized with laboratory confirmed COVID-19 novel coronavirus infection.
• PaO2/FiO2 ratio <300 mmHg.
• Illness of any duration, and at least one of the following:

• Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
• Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤94% on room air, OR
• Requiring mechanical ventilation and/or supplemental oxygen.
• Once released from the hospital, women of childbearing potential (WOCBP) and all men must agree to use at contraception methods for 9 months.

Exclusion criteria

• Pregnant or breast feeding.
• Respiratory distress for reasons other than COVID-19 infection (e.g., congestive heart failure (CHF), bacterial pneumonia, etc.).
• Presence of secondary bacterial pneumonia.
• Presence of significant pulmonary fibrosis.
• Hypotension (need for hemodynamic pressors to maintain blood pressure).
• Greater than 7 days on mechanical ventilation.
• Anemia defined as hemoglobin or RBC <75% of the institutional lower limit of normal for race, age and gender.
• History of COPD or bronchospasm prior to COVID-19 infection.
• History of hypersensitivity to ribavirin.
• Any condition that could cause noncompliance with treatment or may otherwise contraindicate the subject's participation in the study
• Subject is currently participating in any drug or device clinical investigation.
• Subject has received an investigational agent or approved drug that, in the Investigator's judgement, may have a chemical or pharmacological interaction with Virazole if administered within 5 half-lives or 30 days of the Baseline Visit.