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

Study Overview
=================
Brief 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.

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

Official Title
-----------------
A Phase 2 Randomized, Single-Blind Study of a Single Dose of Peginterferon Lambda-1a (Lambda) Compared With Placebo in Outpatients With Mild COVID-19

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Drug: Peginterferon Lambda-1a
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study drug Peginterferon Lambda-1a<br>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<br>* Peginterferon Lambda-1a (180 ug subcutaneous injection) single dose along with Standard of Care<br>|
| Placebo Comparator: Placebo injection<br>Study participants will receive a placebo along with the standard of care treatment. | Other: Placebo<br>* Placebo subcutaneous injection along with Standard of Care Treatment for COVID-19 Infection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration Until Viral Shedding Cessation | Time to first of two consecutive negative respiratory secretions obtained by oropharyngeal and/or anterior nare swabs for SARS-CoV-2 by qRT-PCR. | Assessed for up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sars-CoV-2 Viral Load | Log10 Oropharyngeal viral load over time, mean change at day 14 (SD). Sars-CoV-2 RNA level in oropharyngeal and/or anterior nare swabs collected daily. | baseline, day 14 | 
| Area Under the Curve of SARS-COV-2 Viral Load | Log10 viral load area under the curve through day 14, median (IQR). Area under the curve of SARS-CoV-2 viral load in oropharyngeal and/or anterior nare swabs collected daily. | baseline through day 14 | 
| Duration Until Resolution of Symptoms | Duration until resolution of symptoms in days, median (95% CI). Time to alleviation of all symptoms (fever, chills, cough, nasal congestion, muscle pains), defined as the time from initiation of treatment until all symptoms are rated as absent or mild in symptomatic patients. | Up to 28 days | 
| Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronavirus