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

Terminated
COVID-19
COVID

Drug: Pegylated interferon lambda

180 mcg subcutaneous injection of pegylated interferon lambda
Other Name: Lambda

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Massachusetts General Hospital
Boston, Massachusetts, United States

Raymond Chung, MD, Principal Investigator
Massachusetts General Hospital

Eiger BioPharmaceuticals
NCT Number
Keywords
Covid
Coronavirus
MeSH Terms
COVID-19
Interferons