Pegylated Interferon Lambda Treatment for COVID-19

Phase 2

Terminated

• Conditions: COVID; COVID-19
• Interventions: Drug: Pegylated interferon lambda

• Registration Number: NCT04343976
• Lead Sponsor: Raymond Chung

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

Study Timeline

• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-14
• Study Start: 2020-06-22
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30
• Status Verified: 2022-06
• Results First Submitted: 2022-06-07
• Results First Submitted QC: 2022-06-29
• Last Update Submitted: 2022-06-29
• Results First Posted: 2022-07-21
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lambda Treatment	Pegylated interferon lambda	Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda
Saline Placebo	Pegylated interferon lambda	Subcutaneous injection of saline placebo

Primary Outcome Measures

Name	Time	Method
Undetectable COVID PCR at Day 7	7 days	Negative COVID PCR testing 7 days after first lambda dose

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States