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The first participants have been enrolled by Illinois-based Northwestern Medicine in a new clinical drug trial that aims to tackle coronavirus.
“The drug being tested is remdesivir, a novel antiviral drug developed to treat Ebola and which has subsequently been found, in animal models, to have antiviral activity against coronaviruses including MERS and now SARS-Cov-2, the virus that causes [the] COVID-19 disease,” Northwestern Medicine told Fox News. “The randomized, placebo-controlled, double-blind trial will evaluate the safety and efficacy of the drug in hospitalized adult patients diagnosed with COVID-19.”
The medical system explained that the first Chicago-area patient to receive the drug at Northwestern Memorial Hospital is an 89-year-old man in intensive care.
“Participants in the trial receive either a placebo drug or remdesivir intravenously once a day for a maximum of 10 days. If a patient recovers sooner, the treatment is stopped. The patient will be evaluated for 30 days,” Northwestern Medicine explained. “About 50 sites around the country will enroll 440 patients in the trial.”
The international trial, which is sponsored by the National Institute of Allergy and Infectious Diseases' Division of Microbiology and Infectious Diseases of the National Institutes of Health, will last three years.
“I think we’ll get our results soon because the enrollment pace is very quick,” said principal investigator Dr. Babafemi Taiwo, chief of infectious diseases at Northwestern University Feinberg School of Medicine and Northwestern Medicine. “I hope that in a matter of months, we’ll be able to tell whether this therapy is effective or not.”
In an open letter sent out Saturday, Gilead CEO Daniel O’Day said the company is carefully ramping up its efforts to make remdesivir available to coronavirus patients.
Remdesivir, which is awaiting regulatory approval as a coronavirus treatment, is being used in a number of clinical trials across the globe, according to O’Day. In a project designed by regulators, it has also been made available, on an individual basis, to some severely ill patients who cannot participate in clinical trials.
Gilead is shifting to “expanded access” programs, he said, which aim to get the drug to more patients. “With expanded access, hospitals or physicians can apply for emergency use of Remdesivir for multiple severely ill patients at a time,” O’Day explained in the letter. “While it will take some time to build a network of active sites, this approach will ultimately accelerate emergency access for more people.”
Drug trials to treat coronavirus patients have garnered massive attention in recent weeks, although experts have warned that people should not take drugs unless prescribed by a doctor.
In a news conference earlier this month, President Trump and Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn described several approaches that are being tested, such as chloroquine -- a drug long used to treat malaria, and remdesivir.
The National Institutes of Health (NIH) recently began a clinical trial of remdesivir to treat COVID-19. The project at the University of Nebraska Medical Center (UNMC) in Omaha is the first clinical trial in the U.S. to evaluate an experimental treatment for the infectious disease.
Other research into remdesivir includes two clinical trials in China’s Hubei province, according to Gilead. Results from the studies in China are expected in April.
On Feb. 26, Gilead Sciences announced the start of two Phase 3 clinical studies to evaluate the safety and effectiveness of remdesivir to treat adults diagnosed with COVID-19. “These randomized, open-label, multicenter studies will enroll approximately 1,000 patients at medical centers primarily across Asian countries, as well as other countries globally with high numbers of diagnosed cases, beginning in March,” Gilead said. “The studies will assess two dosing durations of remdesivir, administered intravenously.”
Previously, remdesivir was used to treat humans with Ebola. It had also shown promise in animal models for treating the Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), according to the NIH.
As of Tuesday morning, at least 800,049 coronavirus cases have been diagnosed worldwide, at least 164,610 of which are in the U.S. The disease has accounted for at least 38,714 deaths around the world, including more than 3,000 people in the U.S.
The Associated Press contributed to this report.
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