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
Other: Saline
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
Johns Hopkins Hospital
Baltimore, Maryland, United States
Mark Sulkowski, MD, Principal Investigator
Johns Hopkins University