Making the most of a limited resource to help patients with severe COVID-19 across the state

As COVID-19 cases surge in South Carolina and other hot spots around the country, demand continues to grow for remdesivir, one of the only medications that has shown benefit in patients with severe disease. 

An investigational antiviral agent developed by Gilead Science originally to treat Ebola, remdesivir was shown in a clinical trial to speed recovery of patients with severe COVID-19 by 31% and reduce the average hospital stay from 15 to 11 days. Just last week at the Virtual COVID-19 Conference, held during the 23rd International AIDS Conference, Gilead announced that the drug also reduced the risk of death in critically ill patients by 62%, a finding that has not yet been published in a peer-reviewed journal and will need confirmation by future studies.

Unfortunately, Gilead had limited supplies of remdesivir on hand when its benefits for patients with severe COVID-19 were first announced this spring. As a result, federal authorities had to allocate the available treatment courses to states based on their numbers of hospitalized COVID-19 patients. Gilead is now making the drug available commercially, but the federal government will continue to allocate the drug until September.

The allocation has not gone off without a hitch. Hospitals in some states have more remdesivir than they can use while others in hard-hit areas do not have enough to offer to all patients who could benefit. The federal government is working toward a solution, but the inability to target distribution to the hospitals and the patients with the greatest need has been a frustration. 

“I think it's very much to the credit of DHEC and SCHA that they really wanted an ethical framework to inform how South Carolinians received the medication. The key ethical principles were that the process should be patient-centered, equitable, transparent and clinically informed.”

--  Dr. Dee Ford, professor, Division of Pulmonary and Critical Care Medicine 

South Carolina officials recognized early that an equitable and transparent process was needed to ensure its initial allotment of 74 treatment courses would go to those patients who would benefit most. The South Carolina Department of Health and Environmental Control (DHEC) and the South Carolina Hospital Association (SCHA), charged with coming up with such a plan, turned to South Carolina’s leading health systems and ethics experts to establish a remdesivir advisory committee. MUSC Health critical care expert Dee Ford, M.D., is a key contributor. 

Ford was asked to join the advisory group to provide a clinical perspective on the drug’s distribution.  

“I think it's very much to the credit of DHEC and SCHA that they really wanted an ethical framework to inform how South Carolinians received the medication,” said Ford. “The key ethical principles were that the process should be patient-centered, equitable, transparent and clinically informed.”

One of the first decisions was to offer five-day, instead of ten-day, treatment courses, doubling the number of patients who could be helped. A recent study showing similar benefit from five- and ten-day courses of remdesivir confirms the wisdom of that decision.

Another key decision was to base the distribution on designated clinical criteria. Desperately needed, however, was a tool for gathering the necessary clinical data for COVID-19 patients to determine their eligibility. 

 

A clinical researcher who also serves as director of the  Dissemination and Implementation Science Collaborative for the South Carolina Clinical & Translational Research (SCTR) Institute, Ford thought immediately of REDCap, a Vanderbilt-developed research survey tool that is made available at MUSC through SCTR. A link to a REDCap survey can be shared easily by email, and the collected data can be downloaded into Excel files for analysis. 

Most of the other physicians and public health experts serving on the advisory group were unaware of this research tool, but it would turn out to be exactly what they needed to gather the information critical to remdesivir allocation. 

“We had the idea to have a query to obtain a set of clinical criteria that, to the best of our limited knowledge, would mean that the patients most likely to derive the most benefit would be allocated the treatment,” explained Ford.

Ford reached out to Royce Sampson, M.S.N., R.N., CRA, SCTR primary administrator, for help. Sampson championed the project and helped quickly muster SCTR resources to support it.

With the assistance of Stephanie Oppenheimer, a REDCap administrator at SCTR’s SUCCESS Center, the advisory committee developed a REDCap survey to collect clinical data about COVID-19 patients that could be sent to health care institutions statewide. 

“Less than forty-eight hours from when SCTR first heard about it, we were deploying this query out to providers –it was quick,” said Ford.

Stephanie Gentilin, program director of the SUCCESS Center, was able to help Ford obtain Net IDs for officials at DHEC so that they could use MUSC’s REDCap tool and analyze the collected data to make decisions about where the remdesivir would go.

“Through this process, I was really struck by what an example this challenge provided of how when a group of people, each with his or her own strengths, skills, perspective and experience, blend their resources toward a shared goal, that challenge can be addressed with a creative and effective solution at a level I don’t believe any one group would have designed on its own,” said Oppenheimer.

“When a group of people, each with his or her own strengths, skills, perspective and experience, blend their resources toward a shared goal, that challenge can be addressed with a creative and effective solution at a level I don’t believe any one group would have designed on its own."

-- Stephanie Oppenheimer, REDCap administrator, SCTR SUCCESS Center

As the epidemic evolved, the clinical criteria for remdesivir eligibility were adjusted. Initially, the medication was reserved for those without other serious conditions. However, as COVID-19 hit Black and Hispanic populations the hardest, in part because of the higher prevalence of conditions such as diabetes and hypertension, this restriction was removed to ensure the equitable distribution of the drug.

Care was also taken that health care facilities statewide, including those in rural areas, were aware of the tool and could use it to determine if their patients with severe COVID-19 were eligible for a treatment course. Initially, SCHA sent the link to the REDCap survey out via an existing Listserve to hospital officials, but it quickly became clear that it was the “boots on the ground” health care providers who had the needed patient data. The SCHA took the time to identify the appropriate pharmacists and other front-line health care providers at each institution and shared the tool with them. In this way, it helped to ensure that not just the big metropolitan hospitals and their patients had access to this vital resource.

As the tool was being developed, South Carolina received a number of additional allocations of remdesivir from the federal government. Using the clinically informed, patient-centered system it developed, DHEC distributed 2,100 treatment courses of remdesivir between May 15 and July 12: 599 to the Upstate, 388 to the Midlands, 655 to the Pee Dee and 458 to the Lowcountry.   

In late June, the U.S. Department of Health and Human Services announced that it has obtained 500,000 treatment courses of remdesivir from Gilead that would be allocated to states for purchase by hospitals. The advisory committee and DHEC are hoping to continue using their strategic approach for allocation once the drug is commercially available, but that remains, for now, a work in progress. 

As cases continue to spike in South Carolina, having an equitable, transparent and clinically informed system already in place is helping to speed the administration of this potentially lifesaving drug to patients who need it most. 

And the infrastructure that the advisory committee built to ensure the equitable distribution of remdesivir will likely continue to be important as new treatments and vaccines are rolled out.

“This methodology would have the potential to be used for vaccine access or for other therapies, such as convalescent plasma or other antivirals, once they are shown to be valuable,” said Ford. “These kinds of treatments initially are always going to be considered a scarce resource because you’ll have a ramp-up period for production once something has been shown to work.”