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Can hydroxychloroquine prevent COVID-19? President Donald Trump thinks maybe. There's no data to support that.

USA TODAY logo USA TODAY 19-05-2020 Elizabeth Weise, USA TODAY

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President Trump said Monday is he taking hydroxychloroquine, a drug the FDA says is neither safe nor effective in treating COVID-19.

Hydroxychloroquine is FDA-approved to treat autoimmune conditions such as lupus and rheumatoid arthritis. It can also be used to treat some forms of drug-resistant malaria or to protect against certain types of malaria.

The President appears to be taking it as a prophylactic, with the thought it could prevent someone exposed to coronavirus from getting it. There is at least one study looking into this usage underway but no data to support the idea yet. 

a hand holding a remote control: In this file photo taken on February 26, 2020, medical staff at the IHU Mediterranee Infection Institute in Marseille, show packets of Nivaquine, tablets containing chloroquine; and Plaqueril, tablets containing hydroxychloroquine. These drugs have shown signs of effectiveness against coronavirus. © GERARD JULIEN, AFP via Getty Images In this file photo taken on February 26, 2020, medical staff at the IHU Mediterranee Infection Institute in Marseille, show packets of Nivaquine, tablets containing chloroquine; and Plaqueril, tablets containing hydroxychloroquine. These drugs have shown signs of effectiveness against coronavirus.

Hydroxychloroquine can be administered either as a pill or by intravenous drip and is marketed under the brand name Plaquenil. 

Because it is FDA-approved for those diseases, physicians are legally free to prescribe it in any manner they want "off-label," meaning not for the reason listed on the drug's label. 

It is not available over the counter at drug stores. It is also different from chloroquine, an anti-malaria drug that Trump has at times suggested as a treatment or preventative for COVID-19. 

There is no data to support the notion that hydroxychloroquine or chloroquine helps people infected with SARS-CoV-2, the virus that causes COVID-19.

In pictures: Coronavirus (COVID-19) outbreak around the world

There is strong evidence that hydroxychloroquine can cause abnormal heart rhythms and a dangerously rapid heart rate, according to the U.S. Food and Drug Administration. 

“There’s no proof that it works and some people might experience side effects that could be severe. There’s no proof that it works and some people might experience side effects that could be severe,” said Dr. Daniel Kaul, a professor of infectious disease at the University of Michigan school of medicine. “

The FDA has cautioned that hydroxychloroquine should be limited to people in clinical trials, which are carefully overseen, or who are hospitalized, due to concerns about the potentially dangerous adverse effects. 

A study posted on April 21 involving 368 patients with confirmed cases of COVID-19 treated at Veterans Health Administration medical centers found there were more deaths among those given hydroxychloroquine than those receiving standard care. In addition, the drug made no difference in the need for ventilators. 

The U.S. National Institutes of Health launched a large clinical trial of hydroxychloroquine given in conjunction with the antibiotic azithromycin last week. It is among multiple studies underway to see if the drug can help decrease hospitalization and death from coronavirus. 

In a statement on the N.I.H. website about the study, Dr. Anthony Fauci noted that while where was anecdotal evidence that the drugs might benefit some people, "we need solid data from a large randomized, controlled clinical trial to determine whether this experimental treatment is safe and can improve clinical outcomes.”

The University of Minnesota is also in the midst of a large study of whether the drug can be used prophylactically, but it will not be completed until August. 

"There is no data that pre-exposure prophylaxis is effective in prevention COVID-19. The study we're conducting should help us answer the question," said Mahmoud Al-Kofahi, a professor of experimental and clinical pharmacology at the University of Minnesota. 

Another worry is that people taking it might have a false sense that they’re protected from becoming infected COVID-19 or cannot become infected and therefore cannot pass it along.

“The concern would be they might change their behavior and put others at risk,” said Michigan's Kaul.

Hydroxychloroquine craze has French roots

The drug first came to public attention after several small, anecdotal, non-peer reviewed reports about the drugs in China in February. None were up to the scientific gold standard of a double-blind, randomized, placebo-controlled trial that would definitively show they worked or not.

Interest in hydroxychloroquine took off when a controversial microbiologist in France posted a video on Feb. 25 promoting the use of hydroxychloroquine to treat COVID-19. Didier Raoult, has denied climate change is happening and wrote a book declaring Darwin's theory of evolution was wrong.  

Raoult then posted two small studies of the drugs on COVID-19 patients that were quickly criticized by scientists because they had no control group, making it impossible to know if people who got the drugs recovered any faster than those who didn't. 

Television doctor Mehmet Oz initially supported the drug multiple times on Fox and Friends but later backed away from it. 

Trump first spoke about hydroxychloroquine given together with the antibiotic azithromycin on March 19. He went on to tout them numerous times in various media and public events. 

On April 13 he announced his administration had deployed roughly 28 million doses of hydroxychloroquine from the National Stockpile.  "Just recently, a friend of mine told me he got better because of the use of that, that drug," he said in a briefing.  

Since late April Trump had toned down his support of the drug, but during a roundtable discussion with restaurant executives at the White House on Monday said he began about a week and a half ago.

That was around the time two people in the White House who would have been in close contact with him tested positive for COVID-19. One was a valet to the president, the other Vice President Mike Pence's press secretary, Katie Miller.

This article originally appeared on USA TODAY: Can hydroxychloroquine prevent COVID-19? President Donald Trump thinks maybe. There's no data to support that.

Follow the government's latest guidance on safeguarding yourself during the coronavirus pandemic, including travel advice within and outside the country. The World Health Organization has also busted some myths surrounding coronavirus. The Ministry of Health's special helpline is available at +91-11-23978046, ncov2019@gmail.com and ncov2019@gov.in.

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