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

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
Eligibility Age
Minimum: 18 Years
United States

Massachusetts General Hospital
Boston, Massachusetts, 02114

Raymond Chung, MD
Principal Investigator
Massachusetts General Hospital

Raymond Chung
Eiger BioPharmaceuticals
NCT Number
MeSH Terms