CD2H COVID-19

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

Purpose

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.

Condition

COVID-19

Eligibility

Eligible Ages: Between 18 Years and 75 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Study Design

Phase: Phase 2
Study Type: Interventional
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.
Primary Purpose: Treatment
Masking: Single (Participant)
Masking Description: Single-blind study in which only patients are blinded.

Arm Groups

Arm	Description	Assigned Intervention
Experimental Study drug Peginterferon Lambda-1a	Study participants assigned to study drug will receive a single subcutaneous dose of Peginterferon Lambda-1a in addition to standard of care treatment.	Drug: Peginterferon Lambda-1a Peginterferon Lambda-1a (180 ug subcutaneous injection) single dose along with Standard of Care
Placebo Comparator Placebo injection	Study participants will receive a placebo along with the standard of care treatment.	Other: Placebo Placebo subcutaneous injection along with Standard of Care Treatment for COVID-19 Infection