Pegylated Interferon Lambda Treatment for COVID-19

Study Overview
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Brief Summary
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Prospective randomized trial to assess the antiviral efficacy of Pegylated Interferon Lambda (180 mcg SC injection) vs.placebo in up to 20 subjects with COVID-19 infection.

Detailed Description
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The study objective is to assess the efficacy of Pegylated Interferon Lambda (180 mcg) vs. placebo in inducting quantitative PCR negativity at day 7

Official Title
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A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda vs. Placebo in Subjects Infected With COVID-19

Conditions
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COVID-19, COVID

Intervention / Treatment
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* Drug: Pegylated interferon lambda


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide informed consent Confirmed COVID-19 diagnosis based on PCR analysis of respiratory secretions Positive SARS-CoV-2 RT-PCR test must be within 48 hours of randomization Exclusion Criteria: Clinically-significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol Treatment with IFN or other immunomodulatory/immunosuppressive agent within 12 months before screening. Respiratory compromise requiring ventilatory support other than nasal cannula (mask, bipap or intubation and mechanical ventilation) History of treatment with any of the following medications within five half-lives or 30 days before administration of the study drug (whichever is longer): anti-IL-6, anti-IL6R antagonists, Janus kinase inhibitors, ustekinumab (anti-IL-12/23), or anti IL-23 agents (guselkumab). Life threatening SAE during the screening period Pregnant or Nursing Females Platelet count <90,000 cells/mm3 WBC count <3,000 cells/mm3 ANC <1,500 cells/mm3 Hb <11 g/dL for women and <12 g/dL for men CrCl < 50 mL/min Bilirubin level ≥ 1.5x ULN INR ≥1.5 (except in the setting of concomitant anticoagulant use) CRP > 200 mg/L Clinically-relevant alcohol or drug abuse within 12 months of screening Known hypersensitivity to Interferons Current or planned participation in an investigational new drug (IND) trial from 30-days prior to randomization through Day 14 post treatment

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lambda Treatment<br>Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda | Drug: Pegylated interferon lambda<br>* 180 mcg subcutaneous injection of pegylated interferon lambda<br>* Other names: Lambda;|
| Placebo Comparator: Saline Placebo<br>Subcutaneous injection of saline placebo | Drug: Pegylated interferon lambda<br>* 180 mcg subcutaneous injection of pegylated interferon lambda<br>* Other names: Lambda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Undetectable COVID PCR at Day 7 | Negative COVID PCR testing 7 days after first lambda dose | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Undetectable COVID PCR at Day 3 | Negative COVID PCR testing 3 days after first lambda dose | 3 days | 
| Percentage of Subjects on Lambda vs Placebo With Symptomatic Improvement | Daily symptom score improvement during treatment period | 2 weeks | 
| Percentage of Subjects on Lambda vs Placebo With Improved Clinical Outcomes | Time to event for death, intubation, hospital discharge | 2 weeks | 
| Undetectable COVID PCR Testing at Day 14 | Negative COVID PCR testing 14 days after first lambda dose | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID, Coronavirus