By Jackie Kruszewski
C. Kenneth and Dianne Wright Center for Clinical and Translational Research
(804) 828-6671
kruszewskij@vcu.edu

As doctors and nurses focus on saving lives, a VCU researcher’s registry project is building a foundation for virus research.

At first, there were only questions. When the COVID-19 pandemic hit, the only thing known about the virus was how little was known about it.

But while VCU Health doctors and nurses focus on saving lives and finding treatment options, other VCU researchers behind the scenes are setting the stage for long-term investigations into the novel coronavirus.  

Somaya Albhaisi, M.D., an assistant professor in the Department of Internal Medicine at the VCU School of Medicine, has created a COVID-19 registry, and she received one of 31 awards from the COVID-19 Rapid Research Funding Opportunity to do it.

The program, led by the VCU Office of the Vice President for Research and Innovation, with support from the C. Kenneth and Dianne Wright Center for Clinical and Translational Research, awarded nearly $350,000 in funding this spring to VCU research that seeks to address the impact of the coronavirus.

Albhaisi’s registry, officially called the VCU Registry of SARS-CoV-2, is a biobank for future research, a collection of blood samples from COVID-19 patients, linked to a database that stores a wide array of information about those patients.

The idea is that future researchers will use the registry as a foundation to answer some of the many questions about COVID-19. Why do some people develop complications? How do you know which patient is going to do better? Why do some patients die from COVID-19?

“The truth is there are many unknowns about COVID-19,” Albhaisi said. “The registry captures data during the pandemic. It’s an institutional resource to allow translational scientists to engage in research studies around COVID-19 in order to answer important scientific questions, at the present time and in the future.”

The registry consists of two components: a repository of blood samples from COVID-19 patients and a clinical database of patient information, everything from demographics and medical history to symptoms, treatment and progress of the disease while the patient was hospitalized. The two components are linked by unique study codes.

“The registry not only provides blood samples but also the stories of who they belong to,” Albhaisi said.

A unique element of the patient questionnaire is that it asks about socioeconomic background and psychological state. Researchers in the future might ask questions such as, “Did the emotional impact of being hospitalized with COVID-19, away from family, affect clinical outcomes?”.

As with all studies and trials, participation in the registry is voluntary, and patients or their guardians must consent to being included. Albhaisi said the patients they’ve enrolled so far understand the value of the project.

“We’re very grateful to patients for their willingness to participate in the registry,” Albhaisi said. “Research advances science and is essential to improving patient care. Therefore the decision to enroll in a registry is an important one.”

Historically, building registries for infectious diseases has been challenging. A pandemic like COVID-19 has meant all hands on deck, and patient care has been the priority. But it’s also important to preserve data and samples of the disease while it’s active.

More registries coming

Albhaisi’s is one of four active registries and genomic studies at VCU for COVID-19. Others focus on particular antigens in patients’ blood and the evolution of the virus.

And there are more registry projects in the works. A committee led by F. Gerard Moeller, M.D., director of the Wright Center, was created in early April to help evaluate and approve COVID-19 registry projects proposed by VCU researchers.

Albhaisi’s mentor and the co-investigator for her COVID-19 registry, Arun Sanyal, M.D., understands the importance of registries. He’s a liver specialist whose research has centered for years on nonalcoholic fatty liver disease, an umbrella term for a range of common, serious conditions with no known treatments.   

Sanyal’s research has led to breakthroughs for patients. One reason for his success: Sanyal oversees and has access to multiple registries for liver diseases that help him and other researchers make connections among symptoms, treatment, medical history and outcome.

“Registry samples are the backbone of translational human health research,” said Sanyal, an associate director at the Wright Center. “COVID-19 registries like Dr. Albhaisi’s will help answer questions about this virus for years to come.”

Team effort

Albhaisi’s registry, like all registries, is a team effort and requires the tireless support of those at the VCU Medical Center’s Division of Clinical Pathology, its Tissue and Data Acquisition and Analysis Core and the Wright Center’s multidisciplinary informatics team, whose biomedical data expertise is often called upon for clinical trials and human health studies.

“This has been really an exceptional team,” Albhaisi said. “We were able to get the registry up and running within a very short period of time because of an extraordinary team effort from everybody involved. The physicians, nursing staff, lab technicians, informatics and administrative staff came together to integrate the registry with routine clinical care for eligible patients.”

Inquiries coming in from many institutions

Albhaisi said she’s already received a lot of interest from researchers in using her registry. Some want to look at inflammatory markers. Others want to look at immune response. Investigators in neurology want to study incidents of delirium. Another team wants to use the registry to understand the loss of smell and taste in COVID-19 patients.

And other investigators have contacted her to link their own studies to hers, such as radiology with its collection of chest X-rays, to make sure the future VCU researchers have a comprehensive dataset for studying COVID-19.

“I am so proud of VCU investigators and research teams, who are working tirelessly to find solutions for patients with COVID-19,” Albhaisi said. “I am delighted to work on this initiative, and I look forward to seeing the data that will be generated from future studies that hopefully will help lots of people who have this disease.”