This is a phase 2, open-label, single-blinded, randomized trial of a single dose of Peginterferon Lambda-1a compared with placebo in outpatients with mild COVID-19. Study participants will be randomly assigned 1:1 to a single subcutaneous dose of Peginterferon Lambda-1a or placebo along with the standard of care. The primary outcome will be duration of viral shedding in respiratory secretions by of SARS-CoV-2 qRT-PCR in 28 days of follow up.
Interferons are a group of cytokines that have antiviral activity. Interferon lamba is a type III interferon which primarily works on epithelial cells in the respiratory tract where SARS-CoV-2 replicates. Unlike other types of interferons, interferon lambda inhibits viral replication without being pro-inflammatory and does not trigger cytokine storm. This is ideal for treating COVID-19, since the most severe damage is caused by the inflammatory effects.
We are recruiting participants who have tested positive for COVID-19 with mild symptoms who can be treated as outpatients. In addition to one dose of Peginterferon Lambda-1a or placebo, patients will receive serial testing to detect length of viral shedding in respiratory secretions, monitoring of clinical signs and symptoms, and will receive compensation for each visit. Participants must be 18-64 years of age and in generally good health.
