A drug originally developed in an effort to stave off an Ebola pandemic that never materialized is making its way to the Bronx to hopefully help in a much different pandemic: The one featuring the coronavirus that causes COVID-19.
Montefiore Health System and Albert Einstein College of Medicine have both joined a clinical trial designed to evaluate the experimental drug remdesivir, according to the release, among those who are hospitalized with severe COVID-19 symptoms.
Developed by California-based Gilead Sciences in 2015, remdesivir never underwent clinical trials because the Ebola outbreak fizzled out before it could. Yet, scientists believe it could be effective against other viruses, including coronaviruses, and once SARS-CoV-2 started spreading around the world, Gilead ramped up production of remdesivir as a potential emergency treatment for those suffering from COVID-19.
The Bronx trial is sponsored by the National Institute of Allergy and Infectious Diseases, designed for those who have serious lung complications as a result of COVID-19, according to a release. The borough is one of 46 testing sites nationwide, and is the first in New York to open.
The trial is randomized, double-blind and placebo-controlled — all led by Dr. Barry Zingman, a professor of medicine at Einstein, who also is the clinical director of infectious diseases in Montefiore's Moses division. The trial is "adaptive," meaning it can be modified with other therapies to help patients recover from COVID-19.
To be eligible for the trial, patients must be hospitalized with a laboratory-confirmed coronavirus infection that include severe lung complications like rattling sounds when breathing, a need for supplemental oxygen, abormal chest X-rays showing pneumonia, or the need for a mechanical ventilator.
Those in the treatment group receive 200mg of remdesivir intravenously on their first day in the study, getting another 100mg each day for up to 10 days. The placebo group receives an equal volume of a solution with inactive ingredrients.
Montefiore and Einstein hospital administrators do warn, however, that no therapies to treat COVID-19 has been approved by the U.S. Food and Drug Administration, and that it's not clear whether remdesivir will actually be effective with COVID-19 patients.
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