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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04343976
Recruitment Status : Enrolling by invitation
First Posted : April 14, 2020
Last Update Posted : June 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.placebo 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. placebo in inducting quantitative PCR negativity at day 7

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Single blind
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda vs. Placebo in Subjects Infected With COVID-19
Actual Study Start Date : June 22, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : August 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

Placebo Comparator: Saline Placebo
Subcutaneous injection of saline placebo
Drug: Pegylated interferon lambda
180 mcg subcutaneous injection of pegylated interferon lambda
Other Name: Lambda




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, 5, 7 and 14 days after first lambda dose

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

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



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:

  • 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)
  • History of treatment with any of the following medications within five half-lives or 30 days before administration of the study drug (whichever is longer): anti-IL-6, anti-IL6R antagonists, Janus kinase inhibitors, ustekinumab (anti-IL-12/23), or anti IL-23 agents (guselkumab).
  • 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)
  • D-dimer > 1500 ng/mL
  • CRP > 200 mg/L
  • 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


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Raymond Chung
Eiger BioPharmaceuticals
Investigators
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Principal Investigator: Raymond Chung, MD Massachusetts General Hospital
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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: June 24, 2020
Last Verified: June 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

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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 Raymond Chung, Massachusetts General Hospital:
COVID
Coronavirus
Additional relevant MeSH terms:
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Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents