Allies in the war against COVID-19

As MUSC Health leaders began to plan for the onslaught of COVID-19, they thought that Charleston would see the highest increases in hospitalizations in South Carolina. Instead, some of MUSC Health’s regional hospitals, acquired just over 15 months ago, have been the hardest hit. MUSC Health Florence Medical Center, for example, has one-fourth the patient census of MUSC Health Charleston but four times the number of COVID-19 cases.

Fortunately, from the beginning, MUSC Health opted to take a “systems” approach to COVID-19, according to Rami C. Zebian, M.D., chief medical officer of MUSC Health Florence and Marion Medical Centers.

“It is hard for me as a physician and for the medical staff in general to see someone get severely ill and feel that you are helpless, that you don't have much to offer. When we have a new disease, often the only things that are available are experimental therapies offered through clinical trials.”

-- Dr. Rami Zebian, chief medical officer, MUSC Health Florence and Marion Medical Centers

“We said that, as a system, we don't know where COVID-19 will strike hardest, but we have to be ready to mobilize resources, anywhere in the system,” said Zebian.

Although MUSC Health has provided regional hospitals with the necessary  resources to face the crisis, the front-line health care workers, like their fellow caregivers across the nation, felt keenly the lack of treatment options to offer patients against this new foe.

“It's hard for me as a physician and for the medical staff in general to see someone get severely ill and feel that you are helpless, that you don't have much to offer,” said Zebian. “When we have a new disease, often the only things that are available are experimental therapies offered through clinical trials.”

Zebian had been encouraged by MUSC Health leadership at every turn to ask for what he needed. So when he heard that a convalescent plasma study had opened at MUSC Health Charleston, he picked up the phone to ask whether it could be brought to Florence. The study is testing whether antibodies in plasma from patients who have had COVID-19 can help patients with severe COVID-19 fight the disease better.

On the other end of the telephone call were leaders at the South Carolina Clinical and Translational Research (SCTR) Institute. SCTR is one of more than 60 Clinical and Translational Awards hubs nationwide dedicated to speeding the translation of research breakthroughs into the clinic. During the crisis, SCTR has been pulling out all the stops to fast-track the activation of promising COVID-19 trials on the Charleston campus.

 

Zebian had met with SCTR leaders last fall when they traveled to Florence to learn about the community’s needs and to discuss opportunities for expanding the availability of clinical trials.  During the visit, SCTR co-principal investigator Patrick Flume, M.D. had been impressed by the level of community interest.

“And what I found so impressive was the people who came: mayors, sheriffs, the head of their EMT group, school board officials and community representatives,” said Flume. “They looked at it as an opportunity.”

Expanding clinical research to the regional hospitals and to rural areas is one of the goals of SCTR, which was just awarded a five-year grant renewal to continue its work. To meet that goal, it had already been working to build the infrastructure to conduct trials remotely. Those efforts ramped up during the COVID-19 lockdown, when many traditional trials adapted to a virtual format.

“When COVID hit, that was just an accelerant for our efforts,” said Flume.

So when SCTR received Zebian’s call, a number of research teams jumped into action.

These included the Research Opportunities Core within the Office of Clinical Research, which fielded potential COVID-19 trials and assessed their fit for the regional hospitals, the Regulatory Knowledge and Support team and navigators at SCTR’s SUCCESS Center, which worked with the MUSC Institutional Review Board to help gain approval for the trials, and the Pulmonary and Critical Care Clinical Research program, which has run the trials.

“Our team is staffing these trials seven days a week to make this happen,” said Ashley Warden, clinical research manager for the MUSC Pulmonary and Critical Care Clinical Research program. “We are helping regional sites to enroll patients into the trials while also providing support to the physicians in Charleston, both pulmonologists and specialists in other fields, who are running the trials here.”

“We don't want these studies just for the sake of doing research –we want to bring hope, and we want to bring real opportunity. And when you have something that actually hits and works, it's a major home run. You know that you can bring something to (...) the people that we serve in the state of South Carolina, not just Charleston.”

-- Dr. Patrick Flume,
SCTR co-principal investigator

None of this could have happened without the support of SCTR’s Research Nexus Laboratory, the Office of Research and Sponsored Programs and the compliance officers in Charleston and at the regional hospitals.  

“It's really been a collaboration of a bunch of people who understand it, are passionate about it and made it work,” said Flume.

“The MUSC and SCTR teams were very helpful and embraced us,” said Zebian. “They told us that there's no difference between doing clinical trials in Florence and in Charleston. We're already doing it via tablets or remotely or signing in via telemedicine. So it doesn't matter where the patient is.”

 SCTR staff began to deliver training in how to conduct research to personnel at the regional hospitals. The providers and newly trained research staff at those sites worked long hours and weekends to get those trials opened.

Within weeks, MUSC Health Florence Medical Center began enrolling its first patients into the convalescent plasma study. Since then, more than 32 patients have been enrolled, as compared with seven in Charleston, demonstrating the importance of being able to reallocate more nimbly research resources to regions with the greatest need. MUSC Health Marion and Lancaster Medical Centers have also begun enrolling patients into the study.

“It’s unbelievable when I look back at where we were a few weeks ago, when we just hoped that one day we might have research or clinical trials. And now, at Lancaster and Marion, a lot of people have designated research roles. That would not have been possible without the health system and without SCTR’s support,” said Zebian.

 

 Pulmonary and Critical Care Research team

Currently, three COVID-19 trials are open at MUSC Health Florence and another is close to opening. In addition to the convalescent plasma study, the open studies include the ORCHID trial that is looking at COVID-19 outcomes for inpatients with symptomatic disease who are taking hydroxychloroquine and the SCTR COVID-19 biorepository, which is collecting specimens from patients tested for COVID-19 in Florence and Charleston. Efforts are under way to bring additional trials to Marion and Lancaster as well. A website has been created to provide information on all active COVID-19 trials.

 SCTR reviews many more COVID-19 trials than it opens. It carefully vets potential trials, according to Flume, to choose those that show the most promise and are the best fit for the needs and the resources of the area.

“We're looking for ones that actually have promise,” said Flume. “We don't want these studies just for the sake of doing research –we want to bring hope, and we want to bring real opportunity. And when you have something that actually hits and works, it's a major home run. You know that you can bring something to these people, and our commitment is to the people that we serve in the state of South Carolina, not just Charleston.”

And SCTR’s dedication to serving the citizens of South Carolina will not end with COVID-19, according to Flume. The relationships and research infrastructure currently being built will make it easier to conduct clinical trials other health problems being faced by those communities, such as the opioid crisis and high levels of smoking.

“I think that the relationships we’re building during the COVID-19 crisis show that we’re fully invested with our regional sites,” said Flume. “We're not going to fly in and do our research and get out. We need for them to be the front line, and we've got the infrastructure for these types of studies, and we'll work together to make that happen.”

Zebian could not agree more.

“We are starting with COVID-19, but we're not stopping there,” said Zebian. “Adding clinical trials to the arsenal of treatments for many diseases here at MUSC Health Florence Medical Center will be a huge win for the community. Patients in the Pee Dee region of South Carolina deserve the best, and MUSC Health and SCTR have been and will continue to be committed to bringing them cutting-edge therapies via clinical trials.”