South Dakota implements statewide hydroxychloroquine clinical trial for potential coronavirus treatment

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EXCLUSIVE: South Dakota Gov. Kristi Noem on Monday announced a statewide clinical trial of hydroxychloroquine for the possible treatment of COVID-19, making her state the first in the country to institute a program exploring the potential effectiveness of the drug in treating and preventing coronavirus.

“From Day One, I’ve said we’re going to let the science, facts and data drive our decision-making in South Dakota,” Noem said in a statement provided to Fox News.

Noem, a Republican, announced the “comprehensive” clinical trial Monday after communicating with White House officials in the last week to “let them know that South Dakota’s medical community was ready to step up and lead the way on research efforts."

CLINICAL TRIAL OF POTENTIAL CORONAVIRUS TREATMENT HYDROXYCHLOROQUINE BEGINS, NIH SAYS

“I made direct requests to President Trump and Vice President Pence to supply us with enough hydroxychloroquine so that it could be made available for every hospitalized person the state may have, as well as those for health care workers on the frontlines and those in the most vulnerable populations,” Noem said.

The governor said South Dakota has received doses of hydroxychloroquine to begin the trial.

“Today, I’m pleased to report we have received the initial doses we need, and thanks to the leadership of Sanford Health and the assistance of medical teams at Avera and Monument Health, we’re going to be the first state in the nation to do a comprehensive clinical trial to assess whether hydroxychloroquine can treat and perhaps even prevent COVID-19,” she said.

Sanford Health is the largest provider of rural health care in the country, according to Noem. With the help of Avera and Monument Health, they will treat “up to 100,000 people including outpatient and hospitalized patients with COVID-19, in addition to frontline health care workers, and high-risk individuals who have been exposed to the virus.”

“The health care community in South Dakota consistently works together with the state for the benefit of all our patients,” South Dakota Secretary of Health Kim Malsam-Rysdon said Monday. “I am excited patients across the state will have access to this drug, and we will learn more about its benefits in treating and even preventing COVID-19.”

The drug has been a source of political controversy as President Trump has repeatedly touted it as a possible treatment for COVID-19. Critics of the president have pushed back by emphasizing that scientists have not yet determined whether the drug works or is safe in treating coronavirus.

The effectiveness of hydroxychloroquine has been a source of debate within the medical community, with some warning it’s too soon to know if it’s an efficacious option in treating patients with the novel virus.

Dr. Anthony Fauci of the White House coronavirus task force has urged caution when it comes to the drug. “We still need to do the definitive studies to determine whether any intervention, not just this one, is truly safe and effective,” Fauci recently said on Fox News.

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South Dakota’s announcement comes days after the National Institutes of Health said it would run a human clinical trial for hydroxychloroquine, which typically serves as an antimalarial drug, as an option to treat patients with COVID-19. The trial, which started last week, began with 500 adult participants enrolled at Vanderbilt University Medical Center in Nashville, Tenn.

The trial is placebo-controlled and randomized, meaning some of the patients will be treated with hydroxychloroquine while others will not. However, “all participants in the study will continue to receive clinical care as indicated for their condition,” the NIH said.

Theoretically, the drug, with its ability to quiet an immune system response, could help prevent a COVID-19-infected person’s immune system from going into overdrive, attacking the virus so vigorously that it ultimately causes organ failure and death, as has occurred in some patients. Though preliminary studies have shown the drug protects lab-grown cells from the virus, the human clinical trial is aimed at evaluating its “safety and effectiveness” in treating coronavirus patients, according to the NIH.

The drug has also faced shortages since being touted as a possible treatment option, namely affecting lupus patients who depend on it to treat the auto-immune disorder.

“The drug has demonstrated antiviral activity, an ability to modify the activity of the immune system, and has an established safety profile at appropriate doses, leading to the hypothesis that it may also be useful in the treatment of COVID-19,” the NIH said in a news release last week, though warned: “The drug is not without risks, as even short term use can cause cardiac arrhythmias, seizures, dermatological reactions and hypoglycemia.”

Fox News' Madeline Farber contributed to this report.