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 inpatient 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

Enrolling by invitation
COVID-19
COVID

Drug: Pegylated interferon lambda
180 mcg subcutaneous injection of pegylated interferon lambda
Lambda Treatment
Saline Placebo
Other Name: Lambda

Eligibility Criteria

Inclusion Criteria: - Able to provide informed consent - Admitted to the hospital (MGH) with COVID-19 infection - 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Massachusetts General Hospital
Boston, Massachusetts, 02114

Raymond Chung, MD
Principal Investigator
Massachusetts General Hospital

Raymond Chung
Eiger BioPharmaceuticals
NCT Number
Keywords
Covid
Coronavirus
MeSH Terms
Interferons