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Doctors at regional health systems said it’s too early to draw conclusions about remdesivir, an experimental drug government officials tout as showing promising signs in treating patients with COVID-19.
Officials from Stony Brook Medicine, Northwell Health, Mount Sinai South Nassau and Catholic Health Services said there are a limited number of patients in their systems participating in the clinical trials.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said this week that he expects the drug to be approved by the U.S. Food and Drug Administration for emergency use soon. Remdesivir, which is given intravenously, has been in development as an anti-viral drug for years and tested on viruses including Ebola and SARS. It has yet to be approved for any purpose.
“The amount of patients who have enrolled here at Stony Brook is too small to be able to come to a conclusion regarding overall efficacy of this medication,” said Dr. Sharon Nachman, an infectious disease expert at Stony Brook Children’s Hospital. “Trials can have very strict inclusion-exclusion rules, and we are looking at the sickest of patients with COVID-19 for enrollment.”
At Stony Brook, participating patients must be on a ventilator and not on more than one drug to help regulate low blood pressure. Stony Brook has tested the medication in almost 20 adults and fewer than 10 children, Nachman said.
“The silver lining is the drug has not shown toxicity,” Nachman said.
Foster City, California-based Gilead Sciences, a biopharmaceutical company, developed Remdesivir and is running the clinical trials that regional hospitals are participating in.
In a trial sponsored by the National Institutes of Health, hospitalized patients with advanced COVID-19 and lung involvement who received Remdesivir recovered faster than similar patients who received a placebo, according to a preliminary data analysis from a randomized, controlled trial involving 1,063 patients, which began Feb. 21.
The NIH defines recovery as being well enough for hospital discharge or returning to a normal activity level.
Results also suggested a survival benefit, with a mortality rate of 8% for the group receiving Remdesivir versus 11.6% for the placebo group. More detailed data will be available in a forthcoming report, the NIH said. The study was closed to patients April 19.
Rockville Centre-based Catholic Health Services joined a Remdesivir trial for severely sick patients two weeks ago, said Dr. Uzma Syed, infectious disease specialist for Good Samaritan Hospital Medical Center in West Islip.
CHS is doing its part to create “statistically significant data” in the study, Syed said. She said 10 patients at the health system have been part of the trial.
Mount Sinai South Nassau hospital in Oceanside has tested Remdesivir on about 25 patients who were intubated, said Dr. Aaron Glatt, chair of medicine and chief of infectious diseases at the hospital.
“Twenty-five patients doesn’t give you an answer,” he said. “But the NIH study showed very encouraging preliminary information.”
New Hyde Park-based Northwell Health, the largest health system in the state, said it too was involved in Remdesivir studies. Northwell didn’t disclose how many patients have been involved in the trials.
Northwell said it has enrolled about 700 COVID-19 patients in six clinical trials.
“It’s remarkable to see all these trials go live in a record amount of time,” said Dr. Marcia Epstein, associate chief of medicine, infectious diseases, at North Shore University Hospital in Manhasset, who added that it often takes months, if not a year, to launch clinical trials.
David Reich-Hale reports on the business of health care, banking and other topics. He joined Newsday in 2014. He has also worked at American Banker and the New Haven Register. He is from Trumbull, Connecticut.