Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19

Patients will attend up to 9 study visits over a period of up to 28 days.

Inclusion criteria

• Age ≥ 18 years and ≤ 75 years at the time of the assessment
• Able and willing to understand the study, adhere to all study procedures, and provide written informed consent
• Diagnosis of COVID-19 disease:

• If symptomatic, the presence of mild to moderate symptoms without signs of respiratory distress, with FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 within 72 hours from swab to the time of commencing informed consent:
• If asymptomatic, initial diagnosis of SARS-CoV-2 infection with positive FDA-cleared molecular diagnostic assay obtained no more than 72 hours from initial swab to the time of commencing informed consent

Exclusion criteria

• Patients who are hospitalized for inpatient treatment or currently being evaluated for potential hospitalization at the time of initiation of informed consent
• Patients with a known allergy to Peginterferon Lambda-1a or any component thereof
• Display symptoms of respiratory distress (Respiratory rate >20, room air oxygen saturation of <94%.)
• Participation in a clinical trial with or use of any investigational agent within 30 days before screening
• Treatment with interferons (IFN) within 12 months before screening
• Previous use of Peginterferon Lambda-1a
• History or evidence of any intolerance or hypersensitivity to IFNs or other substances contained in the study medication.
• Female patients who are pregnant or breastfeeding. Male patients must confirm that their female sexual partners are not pregnant.
• Current or previous history of decompensated liver disease (Child-Pugh Class B or C) or hepatocellular carcinoma
• Co-infected with human immunodeficiency virus (HIV)
• Significant abnormal laboratory test results at screening.
• Other significant medical condition that may require intervention during the study
• Concurrent use of any of the following medications:

• Therapy with an immunomodulatory agent
• Current use of heparin or Coumadin
• Received blood products within 30 days before study randomization
• Use of hematologic growth factors within 30 days before study randomization
• Systemic antibiotics, antifungals, or antivirals for treatment of active infection within 24 hours before study randomization
• Any prescription or herbal product that is not approved by the investigator
• Long-term treatment (> 2 weeks) with agents that have a high risk for nephrotoxicity or hepatotoxicity unless it is approved by the medical monitor
• Receipt of systemic immunosuppressive therapy within 3 months before screening