Interferon Lambda Therapy for COVID-19

Study Overview
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Brief Summary
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The main purpose of this research study is to test the safety and effectiveness of an investigational drug peginterferon lambda-1a in treating COVID-19.

Detailed Description
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Primary Objective: Determine efficacy of pegylated interferon lambda as measured by clinical improvement. This will be defined as improvement in supplemental oxygen requirement. Secondary Objectives: Determine safety and tolerability of pegylated interferon lambda Days with fever Time to resolution of fever Rate of progression to requiring critical care Overall survival Time to discharge Exploratory Objectives: Determining the effect systemically on inflammatory markers in the blood, as well as viral load. Diagnosis and Main Inclusion Criteria: Patients must have a confirmed diagnosis of infection with SARS-CoV-2 and be receiving supplemental oxygen. Many patients may be receiving hydroxychloroquine with or without other antimicrobials.

Official Title
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A Randomized Phase 2 Trial of Peginterferon Lambda-1a (Lambda) for the Treatment of Hospitalized Patients Infected With SARS-CoV-2 With Non-critical Illness

Conditions
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SARS-CoV-2

Intervention / Treatment
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* Drug: Peginterferon Lambda-1A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of SARS-CoV-2 Hospitalization due to diagnosis with SARS-CoV-2 Sp02 < 93% on ambient air or PaO2/FiO2 < 300 mmHg and requires supplemental oxygen Exclusion Criteria: Patients must not be pregnant or nursing Patients cannot be admitted to intensive care unit at time of admission or require positive pressure ventilation Patients cannot be requiring continuous supplemental oxygen normally (pre-SARS-CoV-2) Patient is receiving steroids >1mg/kg Has diagnosis of primary immunodeficiency Has active autoimmune disease that has required systemic treatment in the past year Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial Patients with ferritin >2000ng/mL and/or C-reactive protein >100mg/L History of allogeneic hematopoietic cell transplantation or solid organ transplantation Childs-Pugh class B or C cirrhosis or class A if portal hypertension is present Documented allergic or hypersensitivity response to protein therapeutics No serious disease requiring mechanical ventilation at time of enrollment

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
Interventional Model Description: Cohort A: Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once Cohort B: Best supportive care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peginterferon lambda-1a<br>Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once | Drug: Peginterferon Lambda-1A<br>* Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once<br>* Other names: Interferon Lambda;|
| No Intervention: Best supportive care<br>Best supportive care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with resolution of hypoxia | The clinical improvement as defined as resolution of hypoxia requiring supplemental oxygen to maintain SpO2>92% at 7 days. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events. | Number of Grade 3 or 4 adverse events as determined by the DAIDS criteria over the course of 3 months from initiation of trial to measure safety and tolerability of pegylated interferon lambda. Information on adverse events will be collected during hospitalization and then as an outpatient until 90 days from the time of receipt of treatment. | until 90 days after receipt of treatment | 
| Days with fever | Number of days participant has a fever. Information on fever will be collected during hospitalization. Cessation of fever is defined as the beginning of the first 48 hour period without fever without the use of antipyretic drug. | during hospitalization, average of 7 days | 
| Time to resolution of fever | This is defined as time from initial treatment with investigational agent, to the cessation of fever, defined as the beginning of the first 48 hour period without fever without the use of antipyretic drug. | during hospitalization, average of 7 days | 
| Rate of progression to requiring critical care | Defined as time from initial treatment with investigational agent to deterioration of clinical condition necessitating transfer to a critical care unit and/or intubation. | during hospitalization, average of 5 days | 
| Overall survival | Information on survival will be collected during hospitalization and then, for those patients discharged, will be collected as an outpatient until 90 days from the time of receipt of treatment | until 90 days after receipt of treatment | 
| Time to discharge | This is defined as the amount of time (in days or fraction thereof) between the receipt of investigational agent and discharge from The Mount Sinai Hospital to home or nursing home, or censoring at time of death. | average of 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peginterferon lambda-1a, Lambda, SARS-CoV-2