Pegylated Interferon Lambda Treatment for COVID-19

Purpose

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.

Conditions

  • COVID-19
  • COVID

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)
Masking Description
Single blind

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04343976
Status
Terminated
Sponsor
Raymond Chung

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