Interferon Lambda Therapy for COVID-19

Icahn School of Medicine at Mount Sinai

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

SARS-CoV-2

Interventions

Peginterferon Lambda-1ADRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 7 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.