Official Title
Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 Infection
Brief Summary

This is a phase 2b prospective, randomized, single-blind, controlled trial of a single subcutaneous injection of peginterferon lambda-1a versus placebo for prevention of SARS-CoV-2 infection in non-hospitalized participants at high risk for infection due to household exposure to an individual with coronavirus disease (COVID-19). The study will also evaluate the regimens participants with asymptomatic SARS-CoV-2 infection detected at study entry. All participants will be followed for up to 12 weeks.

Recruiting
SARS-COV2

Drug: Peginterferon lambda alfa-1a subcutaneous injection
Peginterferon lambda-1a 180 micrograms by subcutaneous injection
Peginterferon lambda alfa-1a

Other: Saline
Saline subcutaneous injection
Placebo

Eligibility Criteria

Inclusion Criteria: - Willing and able to provide written informed consent - Peripheral capillary oxygen saturation (SpO2) ≥ 95% on room air at screening - Age ≥18 years

Exclusion Criteria: - Hospitalized or impending hospitalization at the time of screening - Symptoms of cough, fever or shortness of breath within 72 hours - Prior or current treatment with other experimental or approved agents targeting SARS-CoV-2 or SARS-CoV-1 - Positive pregnancy test - Active autoimmune disease or sarcoidosis (with the exception of controlled thyroid disease) - Active decompensated liver disease (ascites, encephalopathy) - Active congestive heart failure

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 80 Years
Countries
United States
Locations

Johns Hopkins Hospital
Baltimore, Maryland, 21287

Recruiting

Investigator: Stephanie Katz, RN, MSN
Contact: 410-955-7568
ssneddo2@jhmi.edu


Investigator: Mark Sulkowski, MD
Contact: 410-955-7538
msulkowski@jhmi.edu

Investigator: Mark S. Sulkowski, MD

Contacts

Stephanie Katz, RN, MSN
410-955-7538
ssneddo2@jhmi.edu

Mark Sulkowski, MD
410-955-7538
msulkowski@jhmi.edu

Mark Sulkowski, MD
Principal Investigator
Johns Hopkins University

Johns Hopkins University
Eiger BioPharmaceuticals
NCT Number
Keywords
SARS-CoV-2
Covid-19
Lambda interferon
MeSH Terms
Infection