Pegylated Interferon Lambda Treatment for COVID-19
Primary Purpose
COVID-19, COVID
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pegylated interferon lambda
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID, Coronavirus
Eligibility Criteria
Inclusion Criteria:
- Able to provide informed consent
- 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 ≥ 1.5x ULN
- INR ≥1.5 (except in the setting of concomitant anticoagulant use)
- 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lambda Treatment
Saline Placebo
Arm Description
Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda
Subcutaneous injection of saline placebo
Outcomes
Primary Outcome Measures
Undetectable COVID PCR at Day 7
Negative COVID PCR testing 7 days after first lambda dose
Secondary Outcome Measures
Undetectable COVID PCR at Day 3
Negative COVID PCR testing 3 days after first lambda dose
Percentage of Subjects on Lambda vs Placebo With Symptomatic Improvement
Daily symptom score improvement during treatment period
Percentage of Subjects on Lambda vs Placebo With Improved Clinical Outcomes
Time to event for death, intubation, hospital discharge
Undetectable COVID PCR Testing at Day 14
Negative COVID PCR testing 14 days after first lambda dose
Full Information
NCT ID
NCT04343976
First Posted
April 9, 2020
Last Updated
June 29, 2022
Sponsor
Raymond Chung
Collaborators
Eiger BioPharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT04343976
Brief Title
Pegylated Interferon Lambda Treatment for COVID-19
Official Title
A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda vs. Placebo in Subjects Infected With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Unable to meet enrollment goal, lack of funding.
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Raymond Chung
Collaborators
Eiger BioPharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective randomized trial to assess the antiviral efficacy of Pegylated Interferon Lambda (180 mcg SC injection) vs.placebo in up to 20 subjects with COVID-19 infection.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, COVID
Keywords
COVID, Coronavirus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single blind
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lambda Treatment
Arm Type
Experimental
Arm Description
Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda
Arm Title
Saline Placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneous injection of saline placebo
Intervention Type
Drug
Intervention Name(s)
Pegylated interferon lambda
Other Intervention Name(s)
Lambda
Intervention Description
180 mcg subcutaneous injection of pegylated interferon lambda
Primary Outcome Measure Information:
Title
Undetectable COVID PCR at Day 7
Description
Negative COVID PCR testing 7 days after first lambda dose
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Undetectable COVID PCR at Day 3
Description
Negative COVID PCR testing 3 days after first lambda dose
Time Frame
3 days
Title
Percentage of Subjects on Lambda vs Placebo With Symptomatic Improvement
Description
Daily symptom score improvement during treatment period
Time Frame
2 weeks
Title
Percentage of Subjects on Lambda vs Placebo With Improved Clinical Outcomes
Description
Time to event for death, intubation, hospital discharge
Time Frame
2 weeks
Title
Undetectable COVID PCR Testing at Day 14
Description
Negative COVID PCR testing 14 days after first lambda dose
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to provide informed consent
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 ≥ 1.5x ULN
INR ≥1.5 (except in the setting of concomitant anticoagulant use)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Chung, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Coded data is anticipated to be shared with outside institutions. Safety data will be shared with the drug manufacturer
IPD Sharing 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
IPD Sharing Access Criteria
researchers accessing IPD must be an approved and have a data use agreement in place with Partners Healthcare to access the data
Citations:
PubMed Identifier
32788708
Citation
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.
Results Reference
derived
Learn more about this trial
Pegylated Interferon Lambda Treatment for COVID-19
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