The National Institutes of Health has begun a clinical trial of the anti-malarial drug hydroxychloroquine for treatment of adults hospitalized with COVID-19.
The first study participants have been enrolled at Vanderbilt University Medical Center in Nashville, Tennessee, according to an NIH statement released Thursday. The clinical trial aims to enroll more than 500 adults currently hospitalized with COVID-19 or in an emergency department with anticipated hospitalization.
Study participants will be randomly assigned to receive hydroxychloroquine 400 mg twice daily for two doses on the first day, then receive 200 mg twice daily for the next four days or a placebo twice daily for five days.
All study participants will receive clinical care based on their condition, but those randomized to experimental intervention will also receive hydroxychloroquine, the drug President Trump has touted during his White House press briefings.
The trial, called the ORCHID study, is being conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of the National Heart, Lung and Blood Institute (NHLBI).
“Effective therapies for COVID-19 are urgently needed,” said James Kiley, director of the NHLBI’s Division of Lung Diseases. “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. However, we really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19.”
Currently, no therapies have been proven to prevent the progression of COVID-19 to severe illness. Several medicines in the U.S. have been proposed as possible therapies.
Hydroxychloroquine is used to treat malaria and rheumatoid conditions such as arthritis. The drug has demonstrated antiviral activity, an ability to modify the activity of the immune system and demonstrated safety at “appropriate doses” in various studies, leading to the idea that it could possibly help treat COVID-19.
However, the drug does come with risks including cardiac arrhythmias, seizures, dermatological reactions and hypoglycemia.
• Shen Wu Tan can be reached at stan@washingtontimes.com.
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