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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

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID, Coronavirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Data Monitoring Committee

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

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

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Pegylated Interferon Lambda Treatment for COVID-19

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