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

Inclusion Criteria:

1. Age ≥ 18 years and ≤ 75 years at the time of the assessment

2. Able and willing to understand the study, adhere to all study procedures, and provide
written informed consent

3. Diagnosis of COVID-19 disease:

1. 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:

2. 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:

1. Patients who are hospitalized for inpatient treatment or currently being evaluated for
potential hospitalization at the time of initiation of informed consent

2. Patients with a known allergy to Peginterferon Lambda-1a or any component thereof

3. Display symptoms of respiratory distress (Respiratory rate >20, room air oxygen
saturation of <94%.)

4. Participation in a clinical trial with or use of any investigational agent within 30
days before screening

5. Treatment with interferons (IFN) within 12 months before screening

6. Previous use of Peginterferon Lambda-1a

7. History or evidence of any intolerance or hypersensitivity to IFNs or other substances
contained in the study medication.

8. Female patients who are pregnant or breastfeeding. Male patients must confirm that
their female sexual partners are not pregnant.

9. Current or previous history of decompensated liver disease (Child-Pugh Class B or C)
or hepatocellular carcinoma

10. Co-infected with human immunodeficiency virus (HIV)

11. Significant abnormal laboratory test results at screening.

12. Other significant medical condition that may require intervention during the study

13. Concurrent use of any of the following medications:

1. Therapy with an immunomodulatory agent

2. Current use of heparin or Coumadin

3. Received blood products within 30 days before study randomization

4. Use of hematologic growth factors within 30 days before study randomization

5. Systemic antibiotics, antifungals, or antivirals for treatment of active
infection within 24 hours before study randomization

6. Any prescription or herbal product that is not approved by the investigator

7. Long-term treatment (> 2 weeks) with agents that have a high risk for
nephrotoxicity or hepatotoxicity unless it is approved by the medical monitor

8. Receipt of systemic immunosuppressive therapy within 3 months before screening