Interferon Lambda Therapy for COVID-19

Mount Sinai Health System

Status and phase

Withdrawn

Phase 2

Conditions

SARS-CoV-2

Treatments

Drug: Peginterferon Lambda-1A

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04388709

GCO 20-0820

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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