Even before West Virginia reported its first case of the novel coronavirus, Dr. Sally Hodder and her team recognized the need for a COVID-19 patient data registry.
It was after attending a January conference at the National Institutes of Health when Hodder, an infectious disease specialist who lived through the 1980s AIDS/HIV epidemic, predicted with confidence that we'd soon have a pandemic on our hands.
Her colleagues at the West Virginia Clinical and Translational Science Institute at West Virginia University, of which she directs, knew likewise.
So they started building a patient data registry, in collaboration with WVU Medicine, although there were no patients to put in it at the time. Now, the WVCTSI's COVID-19 registry contains more than 7,500 negative cases and 450 positives from individuals tested through the WVU Medicine system.
"We're not going to be done with this virus after one wave of infections," Hodder warned. "In my opinion, until we have an effective vaccine, there will be multiple waves. If you look at the influenza pandemic of 1918 - yes, it was a different virus but it killed about 50 million people worldwide before it was done. And the second wave was deadlier than the first."
Updated daily, the registry includes detailed information from patients including testing method, ICU stays, ventilator use, medications, vital signs, preexisting conditions, labs, procedures, and basic demographics such as age, gender and race, to name a few. Identifiable personal information, such as patient names, is not included. Researchers are provided specific datasets upon approval.
In the clinical and research worlds, patient registry data is utilized by scientists to assess health outcomes for a population. This project further represents how WVU and WVCTSI are leading the COVID-19 response and serving the residents of West Virginia.
"As COVID-19 escalated in Europe, I spoke to our team about the need to get this built and they built fast," said Wes Kimble, assistant director of clinical research services at WVCTSI who led the charge on the project. "I told them, 'This is going to be the hot topic for years. The research on this is not going away anytime soon.'"
Kimble had already helped develop these types of registries, including one of West Virginia heart failure patients.
It's all consistent with the WVCTSI's goal of creating research infrastructure to address health disparities in the Mountain State.
"We're here to improve health outcomes in the state," said Hodder, also a professor of infectious diseases in the WVU School of Medicine. "Having a patient registry that can provide data that addresses COVID-19 patient outcomes was a no-brainer.
"Initial patient reports of this virus suggested that it was largely a respiratory disease accompanied by pneumonia and fever. More recently, we're seeing it as a multi-organ disease with increasing reports of kidney and liver failure. With a registry like this, you can pull in those variables, which, eight weeks ago, we never understood would be important."
Since news of the registry got out, researchers have flooded WVCTSI with requests, Kimble said. Some of those projects involve convalescent plasma therapy in patients with severe COVID-19, neurological outcomes in COVID-19 patients and predictive modeling to identify high-risk patients.
For now, both Hodder and Kimble view the registry as a project that may not end depending on the uncertain future of COVID-19 outbreaks.
"So it is absolutely, critically important that we have good data sources and look at outcomes in an organized way, in real time, because I think this is with us for the near future," Hodder said.
Questions about the registry should be directed to Kimble or Emily Morgan, WVCTSI data services specialist.
WVCTSI is funded by an IDeA Clinical and Translational grant from the National Institute of General Medical Sciences (U54GM104942) to support the mission of building clinical and translational research infrastructure and capacity to impact health disparities in West Virginia.