An experimental drug once intended to treat Ebola has been given emergency approval by U.S. regulators to treat seriously ill coronavirus patients.
The approval is temporary and Gilead Sciences antiviral drug remdesivir continues to be studied at sites around the country that include the University of Maryland School of Medicine. But early evidence, and high mortality from the virus, persuaded the U.S. Food and Drug Administration not to wait to put it in wider use.
“It becomes the only tool that we have that can be effective for treating COVID-19,” said Dr. Karen Kotloff, principal investigator on the trial in Baltimore. “It will become the standard of care for some hospitalized patients.”
Kotloff said the early data showed a 30 percent reduction in the length of time for patients to recover. She also said it showed a similar reduction in deaths, though the study was refocused to emphasize recovery time.
The numbers don’t sound like much, she said. But using hospital resources for fewer days, an average of about 3 or 4 days, frees up critical health care resources for others.
And COVID-19, the illness caused by the coronavirus, has led to almost 240,000 deaths worldwide, including about 1,100 in Maryland. Potentially, she said, remdesivir could have prevented more than 70,000 deaths.
Researchers organized the remdesivir trial at 68 sites in a matter of weeks recently, an astonishingly fast pace for a large drug trial. It was identified during a review of existing drugs as having potential to treat COVID-19. Remdesivir also was tested to treat Ebola but was never approved for that disease or any other.
More results are expected later in the month and will show more fully the safety and effectiveness of the drug, as well as any potentially dangerous side effects. The drug still needs formal FDA approval for long-term use.
In the meantime, the FDA approved its use in hospitals, where it is given intravenously over five or 10 days to patients who are serious ill, including those on ventilators.
“It is reasonable to believe that the known and potential benefits of [the drug] outweigh the known and potential risks of the drug for the treatment of patients hospitalized with severe COVID-19,” the FDA wrote in a letter to Gilead.
Before the drug trial, there was some concern about its possible effectiveness for critically ill patients. Antiviral drugs generally work by keeping the virus from replicating and spreading inside human cells and are typically given before a virus has progressed so far.
But small studies suggested some benefits. That includes a small “compassionate use” study in which the drug was used with severely sick patients for whom there were no other options. Researchers could not say for sure the resulting improvements were due to the drug because there was no comparison group that received the normal course of care.
Another study conducted in China found the drug did not prevent deaths or shorten the length of illness. But that study was small and was ended early when it failed to enroll enough patients.
The other studies also found some possible side effects such as organ dysfunction and gastrointestinal issues.
The large formal study that includes Maryland and several other universities enrolled more than 1,000 people, with some receiving the drug and others not receiving it.
Gilead said it will donate existing remdesivir supplies, about 1.5 million doses, and will scale up production. The federal government will coordinate distribution to hospitals in cities most heavily impacted by the disease.
The emergency use authorization "opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of COVID-19,” said Daniel O’Day, chairman and CEO of the Gilead, in a statement.
O’Day was at the White House Friday when President Donald Trump announced the emergency approval.
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“We will continue to work with partners across the globe to increase our supply of remdesivir while advancing our ongoing clinical trials to supplement our understanding of the drug’s profile," he said. "We are working to meet the needs of patients, their families and healthcare workers around the world with the greatest sense of urgency and responsibility.”
Kotloff said other drugs are in the works to treat COVID-19, and if another one is approved it could be given with remdesivir in a sort of drug cocktail. Researchers are looking into the effectiveness of other antiviral drugs, but also anti-inflammatory drugs. Some of the sickest COVID-19 patients suffer from a surge in inflammation, called a cytokine storm, where the body starts to attack its own cells. It can lead to death.
At the Maryland medical school, the study is being conducted through the Baltimore school’s Vaccine Treatment and Evaluation Unit, which is funded by the National Institute of Allergy and Infectious Diseases and used as a ready resource for evaluating promising infectious disease treatments and vaccines.
The university is also studying another drug approved on an emergency basis for COVID-19 called hydroxychloroquine after it was touted repeatedly by Trump. But the FDA has urged that it only be used in trials because it can have severe side effects, especially for those with heart issues.
The university study of that drug is in healthy people who have been exposed to COVID-19 in their homes or elsewhere as a means of preventing infection or lessening the severity of the illness.
That drug is normally used to treat malaria and lupus, and the attention to it has led to shortages.
Several other treatments and vaccines are under review in the United States and around the world for COVID-19.