Sanford details growing number of clinical trials for COVID-19

June 16, 2020

It’s a bold statement, but one Sanford Health’s Dave Pearce says he can back up:

“As a health system, whether they’re exposed to COVID or have been infected, patients have more options than anyone else, I’ll say, within the United States right now because of the infrastructure we have in place.”

When COVID-19 emerged in the U.S. early this year, there were no immediate ways to treat it aside from trying to control symptoms such as fever and respiratory effects.

That has changed, thanks to an explosion of new therapeutics and existing drugs being used to treat the disease. At Sanford, patients have or will have access soon to at least 17 clinical trials if they are infected with COVID-19 or have been exposed to it.

“The vast majority of them are therapeutic,” said Pearce, president of innovation and research at Sanford Health. “We signed up for a variety of phase one or first-in-human clinical trials … to see which is going to be the most effective.”

In most cases, Sanford is considered a site for the trials. In some, the health system petitioned to the FDA on behalf of patients for expanded access or emergency use of drugs being tried elsewhere.

In one trial, “we had the four, fifth, sixth and seventh patients treated with this one therapeutic,” Pearce said. “It’s still being assessed, (but) the patients are all doing very well. To truly say if it’s a result of the intervention, we need to do more patients. But we’re in the process of running that trial, and we have others we’re literally in the process of opening.”

One of those is a trial with a similar approach to the statewide one Sanford led involving hydroxychloroquine. This one uses a different drug compound and will be offered to see if it prevents someone from contracting COVID-19 after exposure.

“We read about it ourselves, and the protocol will be very similar to (the trial with) hydroxychloroquine,” Pearce said. “It will be administered to individuals we believe have been exposed to COVID.”

The trial has been submitted to the FDA for approval, and the hope is to open it in July.

sanford research lab

Another trial already started uses umbilical cord stem cells to treat COVID-19, an opportunity that resulted from Sanford’s previous stem cell research.

“The company said, ‘We know you can execute,’ ” Pearce said.

Sanford also received some of South Dakota’s supply of Remdesivir, part of a much-publicized trial using the drug to treat COVID-19 patients.

And the health system likely will be at the front of the line assuming Sioux Falls-based SAB Biotherapeutics is cleared to start human trials this summer of its therapeutic designed specifically to target COVID-19.

Sanford also continues to use plasma from recovered patients to treat those infected with COVID-19.

“The vast majority of our patients have been treated with convalescent plasma because it’s safe, and when it comes to some of these other therapies, it’s OK to give them plasma and do these therapies as well,” Pearce said.

“The physicians make the call based on what the patient condition is in terms of which of the therapeutics they want to put them on. We have weekly meetings with our physicians, our infectious disease doctors and pulmonologists … which aids research.”

Treatments for COVID-19 have progressed to the point where “we have a number of novel approaches,” he added. “You want to give it to the sickest of patients to save their lives and because safety is the first criteria. You really hope to have efficacy, but you give it to your sickest patients to see if it can work.”

The hope is to stop the disease before it has time to progress, Pearce added. In some trials, the goal is to see if a treatment can stop the virus from getting into cells. In others, the hope is to minimize respiratory distress or otherwise control symptoms so patients can heal.

Some studies are looking at how genetics may cause different reactions to the virus. Every Sanford patient is put in a registry for tracking.

“This is going to be a wonderful time to advance our understanding of how we use cellular therapies,” Pearce said. “Nine months ago, we would not have considered doing this, but it’s clearly advancing. You have 90 companies using approaches to develop a vaccine, many of which haven’t been applied, and we’re looking under every rock to find a new novel approach to treat COVID.”

All that scientific advancement likely will have broader, positive implications, he added.

“I’ve learned a lot,” Pearce said. “We’ll be able to be prepared for the next pandemic or certainly if there’s a second wave and just understand the whole basis of how a virus can run amok through a population like it has. We’ll be following these individuals for a long period of time.”

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Sanford details growing number of clinical trials for COVID-19

Sanford Health’s research leader details the more than 15 clinical trials underway or planned to start within the health system for COVID-19 patients.

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