FDA approves COVID-19 treatment drug that was used in LI trials
U.S. regulators on Friday allowed emergency use of an experimental drug that appears to help some coronavirus patients recover faster after it part of clinical trials on Long Island.
Officials with the Feinstein Institutes for Medical Research, the research arm of Northwell Health, announced they were conducting two clinical trials of the drug in late March.
Feinstein Institute President and CEO Dr. Kevin Tracy said back when the announcement was made that, "The hope is these two trials, which are both intravenous drugs, will be given in the ICU or to critically ill people and hopefully have some of them turn around."
Tracey said one clinical trial targets patients who appear moderately ill with the virus, while the other is for patients in the ICU with lung failure and low oxygen levels.
A study done by the National Institutes of Health gave more than 1,000 patients either remdesivir or a placebo. Fauci says those on the placebo recovered in 15 days, compared to an 11-day recovery for patients on remdesivir.
Dr. Bettina Fries, chief of the Division of Infectious Diseases at Stony Brook University School of medicine says having approval is one thing, but having it available is another, and she says it is not widely available right now.
There are strict requirements for which COVID-19 patients can be in the trials, and the treatment doesn't help everyone.
"It's not like everybody who gets the drug is going to be alright and all the people who don't get the drug are not going to be alright," says Fries. "There's going to be a lot of other aspects that are going to contribute to the ultimate outcome of the patient."
Shirley Guale and her family believe remdesivir could help her 34-year-old brother Raul recover from COVID-19. The West Sayville man is currently on a ventilator.
"His levels go up and down, it just depends, you know this, this virus is just back and forth," says Shirley.
A representative with Northwell says a person in Raul's situation would need to be approved for a transfer from Mather Hospital to one conducting the trial, be cleared be their personal doctor and meet the guidelines for the trial.
The Guale family says they've been told Raul would not survive a transfer, so they hope that by sharing his story, maybe the drug could be brought to him.
"I would be even willing to pick it up and say, hey, you know, here, I just feel like it's right there, but it's so far," says Shirley.