South Dakota Launches Clinical Trial of Hydroxychloroquine

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South Dakota has launched a clinical trial to test the effectiveness of hydroxychloroquine in treating and potentially preventing COVID-19.

Gov. Kristi Noem (R) on Monday said South Dakota is the first state to conduct a full clinical trial on hydroxychloroquine. The effort is being led by Sanford Health system, the largest rural health provider in the country.

"Our goal is to meaningfully advance the science around COVID-19 so physicians can be better prepared to respond to and treat this novel virus in the future, especially for our populations most at-risk,” Sanford Health's chief medical officer, Allison Suttle, said in a statement. “By doing clinical trials during this pandemic, we are trying to find treatments and, thereby, hope.”

The study initially will include 2,000 outpatient individuals exposed to COVID-19, including front-line health care workers and other high-risk patients.

Hydroxychloroquine is used to treat malaria and rheumatic conditions such as lupus and arthritis. However, its effectiveness at treating COVID-19 has never been proven, despite its embrace by President Trump.

The National Institutes of Health (NIH) last week announced it was also beginning a clinical trial on the use of hydroxychloroquine for COVID-19. However, the NIH trial is focused on people who are already hospitalized with the disease, while the South Dakota study will initially test the possible preventive use of the drug.

Sanford said it has clinical guidelines in place to prescribe hydroxychloroquine to hospitalized COVID-19 positive patients.

The evidence on hydroxychloroquine is conflicting, at best, and is mostly anecdotal. A French study that tested the antibiotic azithromycin with hydroxychloroquine caught the eye of Trump, who has alluded to it from the White House podium. But the study tested only 24 people, and the science has been widely criticized. The journal that published the study announced earlier this month that the study did not meet its standards.

In addition, a small Brazilian study was abruptly halted because some patients taking high doses developed irregular heart rates generating "safety hazards."

Last month, the Food and Drug Administration issued an emergency use authorization allowing health care providers to use the medicine for patients hospitalized with the coronavirus, despite the drug having never been approved as a specific treatment for COVID-19.

Hospitals have widely administered the drug to patients with COVID-19 in the hope that it would help, but there has not been much evidence of its effectiveness.

Even though the drug has been in use since World War II, the NIH has warned that even short-term use can cause cardiac arrhythmias, seizures, dermatological reactions and hypoglycemia.

“While this drug has been widely administered in the hope that it can help people, without controlled research studies we aren’t able to say for sure that it really works," Susan Hoover, principal investigator of the study, said in a statement. "Conducting this study allows us to do everything we can to help our patients now, and at the same time gather critical information that will help patients in the coming months and years."

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