Pegylated Interferon Lambda Treatment for COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04343976
• Other study ID #: 2020P001083
• Status: Terminated
• Phase: Phase 2
• Start date: June 22, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: June 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• COVID-19

Intervention

Drug:
• Pegylated interferon lambda
180 mcg subcutaneous injection of pegylated interferon lambda

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Raymond Chung	Eiger BioPharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Undetectable COVID PCR at Day 7	Negative COVID PCR testing 7 days after first lambda dose	7 days
Secondary	Undetectable COVID PCR at Day 3	Negative COVID PCR testing 3 days after first lambda dose	3 days
Secondary	Percentage of Subjects on Lambda vs Placebo With Symptomatic Improvement	Daily symptom score improvement during treatment period	2 weeks
Secondary	Percentage of Subjects on Lambda vs Placebo With Improved Clinical Outcomes	Time to event for death, intubation, hospital discharge	2 weeks
Secondary	Undetectable COVID PCR Testing at Day 14	Negative COVID PCR testing 14 days after first lambda dose	14 days