COVID-19 Clinical Trial of Immune Therapy Open at Mount Sinai, Made Possible by Philanthropic Donation
Mount Sinai Health System is beginning the first clinical trial in the New York metropolitan region of an immune-boosting therapy in COVID-19 patients.
The Phase 2 randomized trial is expected to recruit 66 patients to study peginterferon lambda in hospitalized patients receiving supplemental oxygen. Peginterferon lambda is injected under the skin as a single, one-time dose, and scientists believe it can help the immune system control the virus infection, decreasing the duration and severity of COVID-19.
“There is significant evidence from laboratory studies done here at Mount Sinai and abroad that patients’ own immune systems are making inadequate amounts of interferon lambda—an alert signal the lungs normally send out to the immune system that a virus is present—when patients are infected with the coronavirus causing COVID-19,” said trial principal investigator Thomas Marron, MD, PhD, Assistant Director of Early Phase and Immunotherapy Clinical Trials at The Tisch Cancer Institute at Mount Sinai. “As naturally occurring interferon lambda is the first line of defense against COVID-19, we have designed a clinical trial that will quickly determine whether treatment with peginterferon lambda will decrease the severity of COVID-19.”
Scientists at Mount Sinai knew about peginterferon lambda from Phase 3 trials for viral hepatitis and felt its antiviral properties would be beneficial to COVID-19 patients based on studies in mouse models. Scott Friedman, MD, Dean for Therapeutic Discovery at the Icahn School of Medicine at Mount Sinai, sought out the maker of the therapy, Eiger Biopharmaceuticals.
Together with Eiger, Dr. Friedman also sought funding from the COVID-19 Early Treatment Fund started by Silicon Valley entrepreneur and philanthropist Steve Kirsch, who in turn found matching funds from donors that include Corrigan Walla Foundation and David Baszucki, the founder and CEO of Roblox Corporation, and his wife, author Jan Ellison Baszucki. The total monetary donation was $500,000, and Eiger Biopharmaceuticals donated the drug for the trial.
“This collaboration between scientists and private industry is what can foster needed drug development for patients during this unprecedented pandemic,” Dr. Friedman said. “We’re hopeful about the prospects for peginterferon lambda based on its activity against SARS-CoV-2, the virus that leads to COVID-19, in cultured cells and animal models and because of its safety in thousands of patients who have received the drug for other conditions. This clinical trial will be important to determine if the drug has activity against COVID-19 in patients.”
Other sites are testing peginterferon lambda’s effectiveness prophylactically and in outpatients with mild COVID-19 cases. Mount Sinai’s Human Immune Monitoring Center, led by Miriam Merad, MD, PhD, Director of the Precision Immunology Institute at the Icahn School of Medicine at Mount Sinai, will perform extensive analysis of patients’ blood to characterize the response to the peginterferon lambda, and help determine if it is effective in activating the immune system to attack the coronavirus.
About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report.