The Montefiore Health System, 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, and Albert Einstein College of Medicine, one of the nation’s premier centers for research, medical education and clinical investigation, has joined a clinical trial to evaluate an experimental drug to treat people with severe COVID-19 infection.
The hospital’s recruitment for the trial began in March and is still underway. Those hospitalized with serious lung complications as a result of COVID-19 might be among the first ones to try remdesivir, the investigational antiviral therapy, developed by Gilead Sciences, Inc. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is serving as a sponsor of the trial.
Ranked No. 6 of the 197 New York City metropolitan area hospitals by U.S. News & World Report, Montefiore-Einstein is one of 46 testing sites nationwide and is the first site in New York State to open. To determine if remdesivir will act as a broad-spectrum antiviral drug against the COVID-19 viral infection, the NIAID launched a multi-center international effort. According to the researchers, remdesivir has shown promise in animal models of severe acute respiratory syndrome (SARS) and the 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.
According to Montefiore Health System and Albert Einstein College of Medicine, all 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 with a positive case of COVID-19 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, they informed.
No therapies have yet been approved by the U.S. Food and Drug Administration for treating COVID-19.