Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Peginterferon Lambda-1a; Placebo
Intervention description: Peginterferon Lambda-1a (180 ug subcutaneous injection) single dose along with Standard of Care; Placebo subcutaneous injection along with Standard of Care Treatment for COVID-19 Infection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An open-label, single-blind randomized controlled trial. Study participants will be randomly assigned 1:1 to a single subcutaneous dose of Peginterferon Lambda-1a or placebo along with the standard of care.
Masking: Single (Participant)
Masking description: Single-blind study in which only patients are blinded.
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Coronavirus

Summary:

      To evaluate the efficacy of a single dose of subcutaneous injections of 180 ug of
      Peginterferon Lambda-1a, compared with placebo in reducing the duration of viral shedding of
      SARS-CoV-2 virus in patients with uncomplicated COVID-19 disease.
    

Eligibility criteria:

        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