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
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 43,000 employees working across eight hospitals, over 400 outpatient practices, nearly 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.
Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 7,300 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country’s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is one of three medical schools that have earned distinction by multiple indicators: It is consistently ranked in the top 20 by U.S. News & World Report's "Best Medical Schools," aligned with a U.S. News & World Report "Honor Roll" Hospital, and top 20 in the nation for National Institutes of Health funding and top 5 in the nation for numerous basic and clinical research areas. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.