Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 (COVID-19) Infection

• Status: Terminated
• Trial end date: 2021-09-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Eiger BioPharmaceuticals

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