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.
Drug: Peginterferon Lambda-1A
Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once
Other Name: Array
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
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Investigator: Lynn Bui
Contact: 212-824-7860
Investigator: Thomas Marron, MD
Thomas Marron, MD, Principal Investigator
Icahn School of Medicine at Mount Sinai