Interferon Lambda Therapy for COVID-19

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

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.

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.

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