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.

Study Overview

• Status: Withdrawn
• Conditions: SARS-CoV-2
• Intervention / Treatment: Drug: Peginterferon Lambda-1A

Detailed Description

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.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Eiger BioPharmaceuticals
• Investigators: Principal Investigator: Thomas Marron, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• Lee JS, Shin EC. The type I interferon response in COVID-19: implications for treatment. Nat Rev Immunol. 2020 Oct;20(10):585-586. doi: 10.1038/s41577-020-00429-3.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Actual): February 5, 2021
• Study Completion (Actual): February 5, 2021

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Peginterferon lambda-1a; Lambda
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Interferons
• Other Study ID Numbers: GCO 20-0820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No