WASHINGTON (AP) — U.S. regulators will allow emergency use of an experimental drug that appears to help some coronavirus patients recover faster.
It is the first drug shown to help fight COVID-19.
The Food and Drug Administration acted Friday after preliminary results from a government-sponsored study showed that the drug remdesivir shortened the time to recovery for hospitalized COVID-19 patients.
The drug also might be reducing deaths, although that’s not certain from the partial results revealed so far.
The research-based biopharmaceutical company, Gilead Sciences, Inc. has been studying Remdesivir for more than 10 years. It said it would donate its currently available stock of the drug and is ramping up production to make more.
Gilead scientists tested the drug as a treatment for hemorrhagic fever viruses such as Ebola, Marburg, and Nipah viruses, as well as other coronaviruses such as SARS and MERS.
When COVID-19 started to turn into a global pandemic, Gilead Sciences put Remdesivir into clinical trials to test how it would work as a treatment. The National Institute of Allergy and Infectious Diseases sponsored the Adaptive COVID-19 Treatment Trial, ACTT.
In February 2020, the first study site opened at the University of Nebraska Medical Center. The trial stopped taking new volunteers on April 19.
One of the ACTT trial sites is right here in the Tampa Bay area at Sarasota Memorial Hospital (SMH.)
There are eight people enrolled in the ACTT trial at SMH. "We are using the experimental drug in very sick people on ventilators, so it is difficult to assess the benefit of the drug on our patients at this time,” said Kirk Voelker, a critical care pulmonologist caring for COVID-19 patients in Sarasota Memorial Hospital’s ICU and medical director and sub-investigator of the health system’s COVID-19 research trials.
Although SMH is in the early phase of the ACTT trial, Voelker said things look promising. "We are seeing positive indications in the trial and are hopeful that this treatment, along with other therapies we are researching, will be effective.”
The initial group of people in the ACTT trial are Americans who quarantined aboard the Diamond Princess cruise ship, which was docked in Yokohama, Japan.
There are 68 study sites around the world, including 47 in the United States. The other test sites are located throughout Europe and Asia.
This week, Dr. Anthony Fauci, director of the NIAID, said findings from the Remdesivir trial are promising. He said the drug reduced the time it takes people to recover by 31 percent — 11 days on average versus 15 days for those just given usual care.
“What it has proven is that a drug can block this virus. This will be the standard of care," Dr. Fauci said.
The National Institutes of Health (NIH) also followed up with its own study and found patients who took Remdesivir recovered faster than patients who did not.
However, the NIH study also found eight percent of patients who took the drug died versus 11.6 percent of patients who did not take Remdesivir.
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