Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19

Exclusion Criteria

• •1. Unable to screen, randomize and administer study drug within 48 hours from arrival to hospital
• •2. Systemic corticosteroid, baricitinib or tofacitinib (or other JAK-STAT signalling pathway inhibitors) therapy within 7 days prior to arrival to hospital or planned for the next days
• •3. Known hypersensitivity or contraindication to natural or recombinant IFN-beta-1a or its excipients, or to dexamethasone or its excipients
• •4. Currently receiving IFN-beta-1a therapy
• •5. Home assisted ventilation (via tracheotomy or non-invasive) except for Continuous Positive Airway Pressure (CPAP) / Bilevel Positive Airway Pressure (BIPAP) used only for sleep-disordered breathing
• •6. Participation in another concurrent interventional pharmacotherapy trial during the study period
• •7. Decision to withhold life-sustaining treatment; patient not committed to full support (except DNR after cardiac arrest only)
• •8. Woman known to be pregnant, lactating or with a positive pregnancy test (urine or serum test)
• •9. Subject is not expected to survive for 24 hours
• •10. Subject has liver failure (Child-Pugh grade C)
• •11. Any clinical condition that in the opinion of the attending clinician or Investigator would present a risk for the subject to participate in the study