Pegylated Interferon Lambda Treatment for COVID-19

A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda vs. Placebo in Subjects Infected With COVID-19

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19; COVID
• Intervention / Treatment: Drug: Pegylated interferon lambda

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

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Lambda
Placebo Comparator: Saline Placebo; Subcutaneous injection of saline placebo	Drug: Pegylated interferon lambda; 180 mcg subcutaneous injection of pegylated interferon lambda; Other Names: Lambda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Undetectable COVID PCR at Day 7	Negative COVID PCR testing 7 days after first lambda dose	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Undetectable COVID PCR at Day 3	Negative COVID PCR testing 3 days after first lambda dose	3 days
Percentage of Subjects on Lambda vs Placebo With Symptomatic Improvement	Daily symptom score improvement during treatment period	2 weeks
Percentage of Subjects on Lambda vs Placebo With Improved Clinical Outcomes	Time to event for death, intubation, hospital discharge	2 weeks
Undetectable COVID PCR Testing at Day 14	Negative COVID PCR testing 14 days after first lambda dose	14 days

Collaborators and Investigators

• Sponsor: Raymond Chung
• Collaborators: Eiger BioPharmaceuticals
• Investigators: Principal Investigator: Raymond Chung, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2020
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Coronavirus; COVID
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Interferons
• Other Study ID Numbers: 2020P001083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No