Pegylated Interferon Lambda Treatment for COVID-19

A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda vs. Placebo in Subjects Infected With COVID-19

Prospective randomized trial to assess the antiviral efficacy of Pegylated Interferon Lambda (180 mcg SC injection) vs.placebo in up to 20 subjects with COVID-19 infection.

The study objective is to assess the efficacy of Pegylated Interferon Lambda (180 mcg) vs. placebo in inducting quantitative PCR negativity at day 7

Inclusion Criteria:

• Able to provide informed consent
• Confirmed COVID-19 diagnosis based on PCR analysis of respiratory secretions
• Positive SARS-CoV-2 RT-PCR test must be within 48 hours of randomization

Exclusion Criteria:

• Clinically-significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol
• Treatment with IFN or other immunomodulatory/immunosuppressive agent within 12 months before screening.
• Respiratory compromise requiring ventilatory support other than nasal cannula (mask, bipap or intubation and mechanical ventilation)
• History of treatment with any of the following medications within five half-lives or 30 days before administration of the study drug (whichever is longer): anti-IL-6, anti-IL6R antagonists, Janus kinase inhibitors, ustekinumab (anti-IL-12/23), or anti IL-23 agents (guselkumab).
• Life threatening SAE during the screening period
• Pregnant or Nursing Females
• Platelet count <90,000 cells/mm3
• WBC count <3,000 cells/mm3
• ANC <1,500 cells/mm3
• Hb <11 g/dL for women and <12 g/dL for men
• CrCl < 50 mL/min
• Bilirubin level ≥ 1.5x ULN
• INR ≥1.5 (except in the setting of concomitant anticoagulant use)
• CRP > 200 mg/L
• Clinically-relevant alcohol or drug abuse within 12 months of screening
• Known hypersensitivity to Interferons
• Current or planned participation in an investigational new drug (IND) trial from 30-days prior to randomization through Day 14 post treatment