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South Dakota to run clinical trial for hydroxychloroquine as COVID-19 treatment

Noem Presser Monument Health 20200318

Gov. Kristi Noem

Gov. Kristi Noem announced Monday that the state will be the first in the nation to run a clinical trial to help determine if hydroxychloroquine can effectively treat COVID-19.

Noem said this is the first “state-endorsed, state-backed, statewide” clinical trial in the U.S. and the state will cover some costs with federal funds it received for the coronavirus.

Noem said in her daily coronavirus briefing that she’s communicated with President Trump, Vice President Mike Pence and Trump senior advisor Jared Kushner about securing enough hydroxychloroquine to treat up to 100,000 South Dakotans.

She spoke with them to make sure “they knew what we wanted to do in South Dakota, that we had all of our health systems on board in partnering with us,” Noem said, noting that the first doses of the drug were sent to the state over the weekend and some South Dakotans may already be part of the trial.

Trials

The state’s three largest hospital systems are joining efforts for the trials. Researchers at Sanford Health’s research group first started the effort and are leading the trials along with Avera and Monument Health in the Black Hills.

Dr. Allison Suttle, chief medical officer at Sanford, said there will be two parts to the clinical trials.

The first trial is a registry trial for patients who have COVID-19. Inpatients can receive hydroxychloroquine with azithromycin, and outpatients can receive just the hydroxychloroquine.

The second trial is a randomized clinical trial for patients who have been exposed to COVID-19, including health care workers, who would receive either the placebo or the drug on a random basis.

Those at high risk, older than 60 or have chronic medical conditions who have been exposed to COVID-19 could also be part of this randomized trial. 

“The outpatient clinical trials are the 2,000 we want to treat,” Suttle said. “The inpatient and the outpatient that have COVID-19, we can treat as many patients as needed in that registry trial, so there’s not a limitation to how many of those are positive with the disease that we can treat. What we really want to find out is does this medication work?”

Suttle said the drug is taken similar to a Z-Pack, which is a drug containing the antibiotic azithromycin and stays in the body from 30 to 50 days.

“It will help those individuals that might be exposed to potentially fight the illness,” Suttle said. “We are learning that it has the potential to work by preventing the virus from entering a cell. That prevents the virus from then spreading.”

The clinical trials are funded by health care organizations, so any patient who wishes to opt-in to the trial in the state can do so for free, Suttle said.

Patients and families will have informed consent for the trials, Suttle said, noting the side effects include nausea, fatigue and “common side effects you can find with a lot of medication.” 

“Now that the state has been able to get enough samples and enough of the medication, every South Dakotan who has COVID-19 can have that discussion with their physician” about if they’re a good candidate for the trial, Suttle said.

She said the trials will not dip into the supply of the drug for patients who need it for lupus, rheumatoid arthritis or other proven treatments.

Suttle said Sanford is also running other clinical trials related to convalescent plasma, other antivirals and therapeutics that work with the immune system.

Smithfield

Sioux Falls Mayor Paul Tenhaken asked Gov. Noem to issue a shelter-in-place order for Minnehaha and Lincoln counties for three weeks as it was announced that 350 Smithfield Foods employees now have COVID-19.

Noem said she would evaluate the shelter-in-place order for Sioux Falls, while Smithfield Foods announced it would close indefinitely starting on Wednesday.

“This is something to look at, but we need to consider that at the appropriate time to make the biggest difference on when you could see people surge into our hospital systems,” Noem said.

Minnehaha County has had substantial community spread of COVID-19 for weeks now, according to the state Department of Health.

Kim Malsam-Rysdon, state health secretary, said she can’t definitively pinpoint the exact cause of the outbreak at Smithfield Foods yet, but noted the substantial community spread of COVID-19 in the area when the first case was discovered there March 26.

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