Trial for Potential Coronavirus Treatment is Underway at Montefiore and Einstein

BRONX, N.Y., April 3, 2020 /PRNewswire/ -- Montefiore Health System and Albert Einstein College of Medicine has joined a clinical trial to evaluate the experimental drug remdesivir to treat people who are hospitalized with severe COVID-19 infection. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring the trial. This treatment has the potential to help people who have serious lung complications as a result of COVID-19. Recruitment for the trial began in March and is still underway. 

Montefiore-Einstein is one of 46 testing sites nationwide and is the first site in New York State to open. NIAID launched the multi-center international effort to determine if remdesivir, a broad-spectrum antiviral drug, acts against COVID-19 viral infection. Remdesivir has shown promise in animal models of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), both caused by human coronaviruses.

The randomized, double-blind, placebo-controlled trial is being led by principal investigator Barry Zingman, M.D., professor of medicine at Einstein and clinical director, infectious diseases, in the Moses division of Montefiore Health System. The trial is "adaptive," meaning it can be modified to include other investigational treatments. "This flexibility allows us to add additional therapies to the trial step-by-step to improve treatment as the pandemic continues," said Dr. Zingman.

Trial participants are hospitalized patients with a laboratory-confirmed coronavirus infection and lung complications, including rattling sounds when breathing, a need for supplemental oxygen, abnormal chest X-rays showing pneumonia, or the need for a mechanical ventilator.

People in the treatment group will receive 200 mg of remdesivir intravenously on the first day of their enrollment in the study and will receive another 100 mg each day for the duration of hospitalization, for up to 10 days total. The placebo group will receive an equal volume of a solution that resembles remdesivir but contains inactive ingredients.

Montefiore and Einstein's robust clinical trial infrastructure contributed to its selection and rapid approval for participation.

No therapies have yet been approved by the U.S. Food and Drug Administration for treating COVID-19.

Remdesivir, an investigational antiviral therapy, was developed by Gilead Sciences, Inc.

About Montefiore Health System

Montefiore Health System is one of New York's premier academic health systems and is a recognized leader in providing exceptional quality and personalized, accountable care to approximately three million people in communities across the Bronx, Westchester and the Hudson Valley. It is comprised of 11 hospitals, including the Children's Hospital at Montefiore, Burke Rehabilitation Hospital and more than 200 outpatient ambulatory care sites. The advanced clinical and translational research at its medical school, Albert Einstein College of Medicine, directly informs patient care and improves outcomes. From the Montefiore-Einstein Centers of Excellence in cancer, cardiology and vascular care, pediatrics, and transplantation, to its preeminent school-based health program, Montefiore is a fully integrated healthcare delivery system providing coordinated, comprehensive care to patients and their families. For more information please visit www.montefiore.org. Follow us on Twitter and view us on Facebook and YouTube.

About Albert Einstein College of Medicine

Albert Einstein College of Medicine is one of the nation's premier centers for research, medical education and clinical investigation. During the 2019-20 academic year, Einstein is home to 724 M.D. students, 158 Ph.D. students, 106 students in the combined M.D./Ph.D. program, and 265 postdoctoral research fellows. The College of Medicine has more than 1,800 full-time faculty members located on the main campus and at its clinical affiliates. In 2019, Einstein received more than $178 million in awards from the National Institutes of Health (NIH). This includes the funding of major research centers at Einstein in aging, intellectual development disorders, diabetes, cancer, clinical and translational research, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Its partnership with Montefiore, the University Hospital and academic medical center for Einstein, advances clinical and translational research to accelerate the pace at which new discoveries become the treatments and therapies that benefit patients. Einstein runs one of the largest residency and fellowship training programs in the medical and dental professions in the United States through Montefiore and an affiliation network involving hospitals and medical centers in the Bronx, Brooklyn and on Long Island. For more information, please visit www.einstein.yu.edu, read our blog, follow us on Twitter, like us on Facebook, and view us on YouTube.

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SOURCE Montefiore Health System; Albert Einstein College of Medicine