Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pegylated Interferon Lambda Treatment 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: NCT04343976
Recruitment Status : Not yet recruiting
First Posted : April 14, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Eiger BioPharmaceuticals
Information provided by (Responsible Party):
Raymond Chung, Massachusetts General Hospital

Brief Summary:
Prospective randomized trial to assess the antiviral efficacy of Pegylated Interferon Lambda (180 mcg SC injection) vs. standard of care in up to 20 inpatient subjects with COVID-19 infection.

Condition or disease Intervention/treatment Phase
COVID-19 COVID Drug: Pegylated interferon lambda Phase 2

Detailed Description:
The study objective is to assess the efficacy of Pegylated Interferon Lambda (180 mcg) vs. standard of care in inducting PCR negativity at day 7

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda vs. Standard Supportive Care in Subjects Infected With COVID-19
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Arm Intervention/treatment
Experimental: Lambda Treatment
Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda
Drug: Pegylated interferon lambda
180 mcg subcutaneous injection of pegylated interferon lambda
Other Name: Lambda

No Intervention: Standard of Care
Clinical supportive treatment for COVID-19 (standard of care)



Primary Outcome Measures :
  1. Undetectable COVID PCR at day 7 [ Time Frame: 1 week ]
    Negative COVID PCR testing 7 days after first lambda dose


Secondary Outcome Measures :
  1. Undetectable COVID PCR at day 3, 10 and 14 [ Time Frame: 2 weeks ]
    Negative COVID PCR testing 3, 10 and 14 days after first lambda dose

  2. Percentage of subjects on Lambda vs standard of care with symptomatic improvement [ Time Frame: 2 weeks ]
    Daily symptom score improvement during treatment period

  3. Percentage of subjects on Lambda vs standard of care with improved clinical outcomes [ Time Frame: 2 weeks ]
    Time to event for death, intubation, hospital discharge



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Able to provide informed consent
  • Admitted to the hospital (MGH) with COVID-19 infection
  • Confirmed COVID-19 diagnosis based on PCR analysis of respiratory secretions
  • Positive SARS-CoV-2 RT-PCR test must be within 48 hours of randomization

Exclusion Criteria:

  • Clinically-significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol
  • Treatment with IFN or other immunomodulatory/immunosuppressive agent within 12 months before screening.
  • Respiratory compromise requiring ventilatory support other than nasal cannula (mask, bipap or intubation and mechanical ventilation)
  • Enrollment in another clinical research study involving a COVID-19 treatment regimen
  • Life threatening SAE during the screening period
  • Pregnant or Nursing Females
  • Platelet count <90,000 cells/mm3
  • WBC count <3,000 cells/mm3
  • ANC <1,500 cells/mm3
  • Hb <11 g/dL for women and <12 g/dL for men
  • CrCl < 50 mL/min
  • Bilirubin level ≥ 2.5 mg/dL
  • Alb <3.5 g/dL
  • INR ≥1.5 (except in the setting of concomitant anticoagulant use)
  • Clinically-relevant alcohol or drug abuse within 12 months of screening
  • Known hypersensitivity to Interferons
  • Current or planned participation in an investigational new drug (IND) trial from 30-days prior to randomization through Day 14 post treatment

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): NCT04343976


Contacts
Layout table for location contacts
Contact: Jenna Gustafson, MSc 6177243836 JLGustafson@mgh.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Contact: Raymond Chung, MD       Chung.Raymond@mgh.harvard.edu   
Contact: Jenna Gustafson, MSc       JLGustafson@mgh.harvard.edu   
Principal Investigator: Raymond Chung, MD         
Sub-Investigator: Arthur Kim, MD         
Sponsors and Collaborators
Raymond Chung
Eiger BioPharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Raymond Chung, MD Massachusetts General Hospital
Layout table for additonal information
Responsible Party: Raymond Chung, Director of Hepatology, MGH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04343976    
Other Study ID Numbers: 2020P001083
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Coded data is anticipated to be shared with outside institutions. Safety data will be shared with the drug manufacturer
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data is anticiapted to be made available within 3 months of study completion. Safety data, specifically treatment related adverse events, will be shared in real time
Access Criteria: researchers accessing IPD must be an approved and have a data use agreement in place with Partners Healthcare to access the data

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raymond Chung, Massachusetts General Hospital:
COVID
Coronavirus
Additional relevant MeSH terms:
Layout table for MeSH terms
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents