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FDA is fast tracking malaria drug to possibly treat coronavirus

Chloroquine, or hydroxychloroquine, used to treat malaria, severe cases of arthritis

French lab scientists in hazmat gear inserting liquid in test tube manipulate potentially infected patient samples at Pasteur Institute in Paris, Thursday, Feb. 6, 2020. Scientists at the Pasteur Institute developed and shared a quick test for the new virus that is spreading worldwide, and are using genetic information about the coronavirus to develop a potential vaccine and treatments. (AP Photo/Francois Mori) (Francois Mori, Copyright 2020 The Associated Press. All rights reserved)

It could be more than a year before a COVID-19 vaccine is developed and tested to treat the current coronavirus pandemic, in the meantime doctors and scientists with the U.S. Food and Drug Administration are looking to drugs already in use for other illnesses to possibly slow or stop the respiratory virus from spreading further.

FDA Commissioner Dr. Steve Hahn said during a White House briefing Thursday that the FDA is examining using a drug called Chloroquine, or hydroxychloroquine, which has been used to treat malaria since 1944 and severe cases of arthritis.

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Hahn said because the drug is already in use and the side affects are known it is safer.

President Donald Trump put it more directly, “If things don’t go as planned, it’s not going to kill anybody,” he said Thursday.

Dr. David Agus, CBS medical correspondent, said Cholorquine can be taken in pill form and works to reduce inflammation.

Agus said if the drug is to work, patients should be taking it as soon as possible, even as soon as they are exposed to the coronavirus.

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Hahn said it was too soon to tell when people could begin receiving treatments with the drug but it is available in pharmacies.

“In short term, we’re looking at drugs that are already approved for other uses,” Hahn said, adding that the FDA is going to do a large clinical trial of the drug to determine its effectiveness, the right dosage and administration.

On Wednesday, the FDA issued new guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus pandemic to allow for some protocol changes.

“The FDA is aware that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19,” a statement from the agency said. "Although the impact of COVID-19 on clinical trials will vary depending on many factors, including the nature of disease under study, the trial design and in what region(s) the study is being conducted, the FDA outlines considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity. Considerations recommended include, among others, sponsors evaluating alternative methods for assessments, like phone contacts or virtual visits and offering additional safety monitoring for those trial participants who may no longer have access to the investigational product or the investigational site.

Trump and Hahn also mentioned other possible treatments, including a drug called Remdesivir, an experimental antiviral that’s being tried in at least five separate experiments, and possibly antibodies culled from the blood of COVID-19 patients after they recover. But no new and imminent treatment was announced.

Meanwhile, other therapies for the coronavirus could take three to six months to to develop and a vaccine for the COVID-19 is in phase 1 after being fast tracked by the FDA with the help from public partners, according to Hahn. A vaccine is still 12 months away at the earliest.

To keep up with the latest news on the pandemic, subscribe to News 6′s coronavirus newsletter or go to ClickOrlando.com/coronavirus.

The Associated Press contributed to this story.


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