Interferon β-1a (IFNβ-1a) in COVID-19 patients (INTERCOP): study protocol for a randomized controlled trial

Area of Science:

• Virology
• Immunology
• Clinical Pharmacology

Background:

• Limited effective pharmacological treatments exist for COVID-19.
• Interferon beta-1a (IFNβ-1a) demonstrates in vitro antiviral activity against SARS-CoV-2.
• IFNβ-1a was a key component in a successful prior COVID-19 therapeutic combination.

Purpose of the Study:

• To evaluate the efficacy and safety of IFNβ-1a as a repurposed drug for COVID-19.
• To assess the impact of IFNβ-1a on viral clearance and clinical outcomes in patients with mild-to-moderate disease.

Main Methods:

• A randomized, controlled, open-label, phase II trial (INTERCOP) involving 126 patients.
• Patients received either IFNβ-1a plus standard of care or standard of care alone.
• The primary outcome was time to negative SARS-CoV-2 swab conversion.

Main Results:

• The study is ongoing; primary and secondary outcome data are pending.
• Exploratory outcomes include analysis of viral load, clinical severity, and immune markers.
• Safety and tolerability of IFNβ-1a will be assessed through adverse event monitoring.

Conclusions:

• IFNβ-1a may reduce infectivity in mild-to-moderate COVID-19 if the primary outcome is met and the treatment is safe.
• Positive results could establish IFNβ-1a as a cornerstone therapy for COVID-19, improving clinical status and hospital stay duration.