Stanford Medical Center launched a clinical trial using a drug called interferon-lambda, a repurposed compound already tested against viruses that cause hepatitis. The investigators have set up a special tent and will administer one dose of the investigational product under the skin, reports investigator Upinder Singh, MD.
Stanford reports that interferons are a group of cytokines that have antiviral activity. For example, interferon lambda 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. An ideal dynamic for treating COVID-19, as most severe damage to patients comes from the inflammatory effects.
According to investigator Dr. Singh, interferon essentially helps the body’s natural immune system into action and has evidenced positive effects on influenza and earlier instances of SARS. As reported by ABC 7 News in the Bay Area, Dr. Singh commented, “This compound was not made for COVID-19, but because we know that it’s safe, it’s easy to give, it has anti-viral activity, we think this is a good compound to test. And now we also have really good animal data.”
The study drug was licensed to Eiger Biopharmaceuticals from Bristol-Myers Squibb in 2016. A neighbor to Stanford—based in Palo Alto, California—Eiger is a late-stage biopharma venture developing and commercializing a pipeline of “first-in-class, well characterized drugs for serious rare and ultra-rare diseases for patients with high unmet medical needs and for which no therapies exist. For company details, see their most recent corporate presentation.
A Phase II, open-label, single-blinded, randomized trial of a single dose of Peginterferon Lambda-1a compared with placebo in outpatients with mild COVID-19, the study investigators randomly assign patients 1:1 to a single subcutaneous dose of Peginterferon Lambda-1a or placebo along with the standard of care. The primary outcome measure will be duration of viral shedding in respiratory secretions of SARS-CoV-2 qrt-PCR in 28 days of follow up. With a target of 120 patients, they will be divided into two arms: a placebo group and the study drug group. The patients will then be monitored ongoing for four-weeks, measuring symptoms and severity of the condition. They hope to have results within two months.
Dr. Singh reports that this study focuses on patients that were recently diagnosed with SARS-CoV-2 within a few days and haven’t developed any material secondary conditions. The study sponsors and participating sites seek to help patients with milder cases recover faster and avoid costly hospitalization.
Call to Action: If you or a loved one know of someone that fits the inclusion criteria in the Bay Area, consider contacting Stanford. Patients will be compensated $40 per visit.