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Clinical Trial of Trump’s Coronavirus Drug Begins

Clinical Trial of Trump’s Coronavirus Drug Begins

The drug has been promoted by President Donald Trump, despite scant evidence that it is an effective treatment for COVID-19.

A pharmacist shows a bottle of the drug hydroxychloroquine on Monday, April 6, 2020, in Oakland, Calif.
Participants will receive 400 mg of hydroxychloroquine twice daily on day one of the trial then receive 200 mg twice daily days two through five.
A CLINICAL TRIAL TO evaluate the safety and efficacy of an anti-malarial drug promoted by the White House as a treatment for the coronavirus is underway, federal officials said Thursday.
The trial of the drug hydroxychloroquine was announced by the National Institutes of Health and enrolled its first patients at Vanderbilt University Medical Center, Nashville, officials said.
President Donald Trump has touted the drug at his daily news briefings, despite warnings from public health authorities who say there is little clinical data to suggest that hydroxychloroquine is an effective treatment for the virus.
Trump's recommendation of the drug, which he has attributed largely to "common sense," has prompted high-profile divisions within the team of advisers working with him on a response to the coronavirus.
Patrice Harris, president of the American Medical Association, told CNN she would not prescribe the medication as a coronavirus treatment and has cited potential risks that include heart rhythm problems.
The test, being conducted by the Prevention and Early Treatment of Acute Lung Injury Clinical Trials Network of the National Heart, Lung and Blood Institute, a division of NIH. It is a blinded, placebo-controlled randomized clinical trial, meaning the participants, treating clinicians, study personnel and outcome assessors do not know who receives the drug and who receives the placebo treatment. Additionally, which participants receive which treatment is random.
Participants receiving the drug treatment will receive 400 mg twice daily on Day One of the trial, then receive 200 mg twice daily days two through five. Those not getting hydroxychloroquine will be given placebo twice daily for five days.
The study is aiming to enroll 510 adults who are currently hospitalized with COVID-19 or who are in an emergency room awaiting hospitalization.
James Kiley, the director of the Division of Lung Diseases at NHLBI, said in a press release that effective treatments for the coronavirus "are urgently needed."
"Hydroxychloroquine has shown promise in a lab setting against SARS-CoV-2, the virus that causes COVID-19, and preliminary reports suggest potential efficacy in small studies with patients," Kiley said. "However, we really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19."
The drug, also known as plaquenil, is currently used to treat malaria, rheumatoid conditions such as arthritis and the autoimmune disease lupus. In some separate studies the drug has been shown to change the activity of the body's immune system, the press release stated, leading experts to believe it may be useful in treating COVID-19.
Trump's statements have led people rushing to stock up on hydroxychloroquine, leading to a shortage for people who regularly take the drug for chronic diseases. Pharmaceutical companies across the world have begun donating tens of millions of doses of hydroxychloroquine to the U.S. and millions of doses have been added to the stockpile.

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