Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 (COVID-19) Infection

Study Overview
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Brief Summary
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This is a phase 2b prospective, randomized, single-blind, controlled trial of a single subcutaneous injection of peginterferon lambda-1a versus placebo for prevention of SARS-CoV-2 infection in non-hospitalized participants at high risk for infection due to household exposure to an individual with coronavirus disease (COVID-19). The study will also evaluate the regimens participants with asymptomatic SARS-CoV-2 infection detected at study entry. All participants will be followed for up to 12 weeks.

Official Title
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Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 Infection

Conditions
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Sars-CoV-2 Infection

Intervention / Treatment
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* Drug: Peginterferon lambda alfa-1a subcutaneous injection
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to provide written informed consent Peripheral capillary oxygen saturation (SpO2) ≥ 95% on room air at screening Age ≥18 years Exclusion Criteria: Hospitalized or impending hospitalization at the time of screening Symptoms of cough, fever or shortness of breath within 72 hours Prior or current treatment with other experimental or approved agents targeting SARS-CoV-2 or SARS-CoV-1 Positive pregnancy test Active autoimmune disease or sarcoidosis (with the exception of controlled thyroid disease) Active decompensated liver disease (ascites, encephalopathy) Active congestive heart failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, single-blind, controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peginterferon lambda alfa-1a<br>peginterferon lambda-1a (Lambda) 180 micrograms by subcutaneous injection for participants who are not infected with SARS-CoV-2 | Drug: Peginterferon lambda alfa-1a subcutaneous injection<br>* Peginterferon lambda-1a 180 micrograms by subcutaneous injection<br>|
| Placebo Comparator: Placebo<br>Placebo (saline) by subcutaneous injection for participants who are not infected with SARS-CoV-2 | Other: Saline<br>* Saline subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With no Evidence of SARS-CoV-2 Infection | Number of participants with no evidence of SARS-CoV-2 infection at or before study day 28. | Up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to no Detection of SARS-CoV-2 | Resolution of SARS-CoV-2 infection in the upper respiratory tract as assessed by time (in days) to no detection of SARS-CoV-2 in two upper respiratory samples. | Up to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, COVID-19, Lambda interferon