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Interferon Lambda Therapy for COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04388709
Recruitment Status : Not yet recruiting
First Posted : May 14, 2020
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
Eiger BioPharmaceuticals
Information provided by (Responsible Party):
Thomas Marron, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE May 12, 2020
First Posted Date  ICMJE May 14, 2020
Last Update Posted Date June 16, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
Number of participants with resolution of hypoxia [ Time Frame: 7 days ]
The clinical improvement as defined as resolution of hypoxia requiring supplemental oxygen to maintain SpO2>92% at 7 days.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
  • Number of adverse events. [ Time Frame: until 90 days after receipt of treatment ]
    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.
  • Days with fever [ Time Frame: during hospitalization, average of 7 days ]
    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 to resolution of fever [ Time Frame: during hospitalization, average of 7 days ]
    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.
  • Rate of progression to requiring critical care [ Time Frame: during hospitalization, average of 5 days ]
    Defined as time from initial treatment with investigational agent to deterioration of clinical condition necessitating transfer to a critical care unit and/or intubation.
  • Overall survival [ Time Frame: until 90 days after receipt of treatment ]
    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
  • Time to discharge [ Time Frame: average of 7 days ]
    This is defined as the amount of time (in days or fraction thereof) between the receipt of investigational agent and discharge from The Mount Sinai Hospital to home or nursing home, or censoring at time of death.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interferon Lambda Therapy for COVID-19
Official Title  ICMJE A Randomized Phase 2 Trial of Peginterferon Lambda-1a (Lambda) for the Treatment of Hospitalized Patients Infected With SARS-CoV-2 With Non-critical Illness
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:

  • 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Cohort A: Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once Cohort B: Best supportive care
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE SARS-CoV-2
Intervention  ICMJE Drug: Peginterferon Lambda-1A
Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once
Other Names:
  • Lambda
  • Interferon Lambda
Study Arms  ICMJE
  • Experimental: Peginterferon lambda-1a
    Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once
    Intervention: Drug: Peginterferon Lambda-1A
  • No Intervention: Best supportive care
    Best supportive care
Publications * Lee JS, Shin EC. The type I interferon response in COVID-19: implications for treatment. Nat Rev Immunol. 2020 Oct;20(10):585-586. doi: 10.1038/s41577-020-00429-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2020)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lynn Bui 212-824-7860 lynn.bui@mssm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04388709
Other Study ID Numbers  ICMJE GCO 20-0820
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Thomas Marron, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Eiger BioPharmaceuticals
Investigators  ICMJE
Principal Investigator: Thomas Marron, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP