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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 : May 18, 2020
Sponsor:
Collaborator:
Eiger BioPharmaceuticals
Information provided by (Responsible Party):
Thomas Marron, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Drug: Peginterferon Lambda-1A Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
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
Official Title: 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
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Arm Intervention/treatment
Experimental: Peginterferon lambda-1a
Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once
Drug: Peginterferon Lambda-1A
Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once
Other Names:
  • Lambda
  • Interferon Lambda

No Intervention: Best supportive care
Best supportive care



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04388709


Contacts
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Contact: Lynn Bui 212-824-7860 lynn.bui@mssm.edu

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Contact: Lynn Bui    212-824-7860    lynn.bui@mssm.edu   
Principal Investigator: Thomas Marron, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Eiger BioPharmaceuticals
Investigators
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Principal Investigator: Thomas Marron, MD Icahn School of Medicine at Mount Sinai
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Responsible Party: Thomas Marron, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04388709    
Other Study ID Numbers: GCO 20-0820
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Marron, Icahn School of Medicine at Mount Sinai:
Peginterferon lambda-1a
Lambda
SARS-CoV-2
Additional relevant MeSH terms:
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Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents