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.

SARS-CoV-2 Infection

Drug: Peginterferon lambda alfa-1a subcutaneous injection

Peginterferon lambda-1a 180 micrograms by subcutaneous injection

Other: Saline

Saline subcutaneous injection

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

- Active decompensated liver disease (ascites, encephalopathy)

- Active congestive heart failure

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

Johns Hopkins Hospital
Baltimore, Maryland, United States

Mark Sulkowski, MD, Principal Investigator
Johns Hopkins University

Eiger BioPharmaceuticals
NCT Number
Lambda interferon
MeSH Terms
Communicable Diseases