Status:
WITHDRAWN
Interferon Lambda Therapy for COVID-19
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Eiger BioPharmaceuticals
Conditions:
SARS-CoV-2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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:...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04388709
Start Date
September 1 2020
End Date
February 5 2021
Last Update
February 26 2021
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