Interferon Lambda Therapy for COVID-19

NCT ID: NCT04388709

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2021-02-05

Brief Summary

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

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.

Conditions

SARS-CoV-2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peginterferon lambda-1a

Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once

Group Type: EXPERIMENTAL

Peginterferon Lambda-1A

Intervention Type: DRUG

Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once

Best supportive care

Best supportive care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Peginterferon Lambda-1A

Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once

Intervention Type: DRUG

Other Intervention Names

Lambda; Interferon Lambda

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eiger BioPharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Thomas Marron

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Marron, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

References

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.

Reference Type: DERIVED

PMID: 32788708 (View on PubMed)

Other Identifiers

GCO 20-0820

Identifier Type: -

Identifier Source: org_study_id