A Phase 2 Multi-Center, Double-Blind, Randomized and Controlled Study of the Safety and Efficacy of Intravenous Recombinant Human Interferon Beta- 1a in Comparison to Dexamethasone for the Treatment of Hospitalized Patients with COVID-19 Infection
Abstract
Viable therapeutic options are extremely limited; therefore, a critical need exists to develop highly effective and rapidly scalable solutions to improve outcomes of severe COVID-19. This proposal directly addresses the programmatic goal of developing therapeutics to treat severe COVID-19. Interferon (IFN) beta-1a (Traumakine [Faron Pharma]) has generated substantial interest in COVID-19 for its known antiviral and immunomodulatory activity. IFN beta-1a plays a key role in host defense against respiratory viruses, preserving endothelial barrier function, and improving alveolar fluid clearance, through CD73-mediated production of adenosine. This phase II, multicenter, blinded, controlled, randomized clinical trial will evaluate IFN beta-1a compared to dexamethasone (control), in addition to standard of care, in patients with severe COVID-19, including pre-ARDS and ARDS. We hypothesize that early administration of intravenous IFN beta-1a will improve clinical status at day 14, compared to dexamethasone, among patients with severe COVID-19. The primary outcome is clinical status at day 14 (where first day of study drug is Day 0) as measured by WHO 9-point ordinal scale: 0 - No detectable infection; 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation; 7 - Hospitalized, on mechanical ventilation plus additional organ support: renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO); 8. Death. This project will efficiently yield an answer on the safety and preliminary efficacy of intravenous interferon beta-1a in the early treatment of severe COVID-19.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 26, 2022
- Accession Number
- AD1228151
Entities
People
- Adit Ginde
- Daniel Talmor
Organizations
- 59th Medical Wing