Pegylated Interferon Lambda Treatment for COVID-19

Raymond Chung

Status and phase: Terminated; Phase 2

Conditions: COVID-19; COVID

Treatments: Drug: Pegylated interferon lambda

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04343976

2020P001083

Details and patient eligibility

About

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.

Full 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

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

14 participants in 2 patient groups, including a placebo group

Lambda Treatment

Experimental group

Description:

Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda

Treatment:

Drug: Pegylated interferon lambda

Saline Placebo

Placebo Comparator group

Description:

Subcutaneous injection of saline placebo

Treatment:

Drug: Pegylated interferon lambda