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.
Drug: Peginterferon lambda alfa-1a subcutaneous injection
Peginterferon lambda-1a 180 micrograms by subcutaneous injection
Saline subcutaneous injection
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
Mark Sulkowski, MD
Johns Hopkins University