Interferon Lambda Therapy for COVID-19

• Status: Withdrawn
• Trial end date: 2021-02-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: Eiger BioPharmaceuticals
• Treatments: Interferons

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