At the onset of the pandemic, many questions were posed as to how the disease would affect children, specifically populations with weakened immune systems or living with respiratory conditions. Leading Le Bonheur’s efforts is Terri Finkel, MD, PhD, vice chair of clinical affairs at Le Bonheur.

“My aim is to connect researchers for collaborative opportunities thatcome out of our weekly ‘think tank’ meetings,” said Finkel. “More than 50 individuals from Le Bonheur, UTHSC, St. Jude Children’s Research Hospital and other nationally-renowned institutions are joining forces to partner on pediatric COVID-19 research efforts.”

Although the pandemic has largely seen the worst outcomes in adults, pediatric cases are still a cause of concern, especially in the Memphis area, according to Le Bonheur COVID-19 census numbers. Le Bonheur researchers have undertaken a variety of investigative efforts to study the impact of COVID-19 on children and to explore questions related to how asymptomatic children spread the disease, with the aim of providing insight into how COVID-19 spreads in a community.

A better understanding of the disease’s effect on children allows Le Bonheur leaders to provide clearer guidance to city leaders, parents and caregivers on how best to keep children safe, whether guiding back-to-school policies or safe return to sports and extracurricular activities.

CIViC-19 study aims to explore clinical, immunological and virological characterization of COVID-19

The rapid appearance of SARS-CoV-2 and its unpredictable clinical impact and outcomes have created opportunities for research into the populations affected by COVID-19. Partnering with the University of Tennessee Health Science Center (UTHSC), Le Bonheur researchers have begun efforts to answer some of the questions that plague medical professionals and pediatric COVID-19 patients. The project is led by Assistant Professor of Pediatrics at UTHSC Heather Smallwood, PhD, who is lead principal investigator, and Le Bonheur Infectious Disease Specialist Nick Hysmith, MD, the clinical director for pediatrics for the study.

countering covid hysmith

Pediatric Infectious Disease Specialist Nick Hysmith, MD (above), and Assistant Professor of Pediatrics at the University of Tennessee Health Science Center Heather Smallwood, PhD, are leading the CIViC-19 study, which aims to uncover more about the clinical, immunological and virological characterization of COVID-19.

“Understanding the relationship between clinical characteristics and what variables influence immune response and severity of the disease are vital to improving diagnosis, prediction and treatment of COVID-19,” said Hysmith.

This study, titled “Clinical, Immunological and Virological Characterization of COVID-19,” or “CIViC-19,” aims to provide a course of action for the clinical and community management of COVID-19. Le Bonheur researchers will manage the pediatric portion of the study, in conjunction with UTHSC researchers who will study adult populations.

Their efforts in the study aim to define what characteristics influence the severity of the disease, explore how the virus is shed by infected individuals and identify potential drug treatment opportunities.

The study will rely on the collection of specimens from adults and children to help investigators learn about this virus. Blood draws and stool samples, as well as oral and nasal swabs, will be taken at various intervals from study participants. This gives Le Bonheur’s researchers the opportunity to better understand whether the virus changes over time and how the body attempts to respond to eliminate the virus.

Team expertise for the study comes from three areas – clinicians with expertise in key patient populations and patient variables, basic researchers in respiratory diseases, immunology and virology and epidemiologists or biostatisticians with expertise in medical informatics.

“This study team builds on existing collaborations and expertise in respiratory viruses, including experience gained during the 2009 H1N1 pandemic,” said Hysmith. “Investigators on this team cover a wide range of expertise required to explore the impact of COVID-19 on vulnerable adult and pediatric populations.”

The dataflow and informatics analysis of the project allows investigators to share information quickly and efficiently via preprint publication repositories, including locally with regional COVID-19 response teams and at national and international levels. In addition, rapid reporting will provide a more accurate risk assessment of key populations in Memphis toward better community management of the virus and its spread.

“Practically, we hope to be able to help the Memphis area return to normal by providing data-driven management of return-to-work and school policies based on the dynamics of viral shedding and details of how the virus spreads,” said Hysmith.

Finally, the CIViC-19 team aims to provide more efficient clinical management of COVID-19 for local health professionals. To accomplish this, the study will identify what factors predict how severe the disease will be in order to facilitate treatment and intervention as early as possible. For those who have already recovered from the disease, the study seeks to effectively identify who has high antibody levels and could donate plasma for treating COVID-19 positive patients. Testing efficacy will also be explored including greater reliability of swab tests and identifying an effective pin prick antibody test.

Serum biorepository aims to provide public health information

Can you develop immunity to COVID-19? How does COVID-19 travel through households? What is the prevalence of asymptomatic positive cases?

These are just a few of the questions that the serum biorepository at the University of Tennessee Health Science Center (UTHSC) hopes to answer. The goal: gather 200,000 serum samples in the Memphis area to test immunity to COVID-19.

Led by Le Bonheur Pediatrician-in-Chief Jon McCullers, MD, the serum biorepository grew out of the need for a more accurate antibody test for SARS-CoV-2. McCullers also serves as senior executive associate dean of clinical affairs and chief operating officer with UTHSC.

Throughout the pandemic, McCullers has led efforts to provide guidance to city leaders, including creating the “Memphis Roadmap” to provide strategic leadership and developing a drive-through COVID-19 testing center. The natural next step is being a resource for reliable antibody testing in the community.

“Previous tests had a high false positivity rate as it reacts against other human coronaviruses,” said McCullers. “The new test is far more sensitive and will allow us to find the true seroprevalence in the Memphis population.”

countering covid mccullers

Le Bonheur Pediatrician-in-Chief and University of Tennessee Health Science Center Senior Executive Associate Dean of Clinical Affairs and Chief Operating Officer Jon McCullers, MD, is leading a serum biorepository with the aim of collecting 200,000 serum samples to test immunity to COVID-19. McCullers has been a guiding voice to Memphis city leadership during the pandemic.

Beginning with health care workers in Memphis, the antibody testing will eventually be available to the general public. These serum samples will be held in the biorepository for researchers to access as they explore questions related to immunity and spread of COVID-19, including its effects on children.

“So far pediatrics has not seen as many antibody tests and positive cases,” said McCullers. “This biorepository will allow us to find the seroprevalence in pediatrics and test entire families to see how they are affected.”

From a public health perspective, the biorepository and antibody test will allow research into whether or not COVID-19 patients have immunity to the disease and, if they do, how long that immunity lasts.

“It’s a Herculean challenge, but determining how the antibodies are linked to immunity and the length of immunity would allow us to determine if those who have recovered from the virus are totally immune,” said McCullers. “This would mean that individual wouldn’t need screening or isolation, and we would feel better about our frontline health care workers who have already beaten the disease.”

National COVID-19 registries allow for collaboration, potential answers

“Pediatric cases of COVID-19 have been far fewer than adults. Registries are vital to be able to learn about how this disease affects kids,” said Le Bonheur Chief of Pediatric Infectious Diseases Sandra Arnold, MD.

Arnold is one Le Bonheur physician providing and using data from national registries surrounding COVID-19 to better understand the disease and its effects onspecific pediatric populations. She coordinates Le Bonheur COVID-19 cases in the Pediatric COVID-19 Case Registry — providing valuable information regarding the disease’s characteristics to physicians around the country.

The Pediatric COVID-19 Case Registry was originally created to record the effects of COVID-19 on compromised or vulnerable children. This population was so small that the registry was opened to any children (20 years and younger) in an effort to follow the disease’s pediatric effect.

countering covid arnold

Chief of Pediatric Infectious Diseases Sandra Arnold, MD, enters information for each of Le Bonheur’s positive COVID patients into the Pediatric COVID-19 Case Registry. Databases like these are essential for the collaboration needed to better understand the effect of COVID-19 on children.

With this information, physicians are able to look at symptoms, pre-existing patient conditions and regional effects of the disease — all important for understanding how COVID-19 can affect patients at Le Bonheur.

“We have so much to learn about this disease and contributing to this registry will help us learn more about positive patient cases and provide the best care for our COVID patients,” says Arnold. “We’re able to see the effects of COVID therapies including anti-viral medication or immune modulatory therapy across the country and the effect that they have.”

Other existing national registries also expanded their datasets to include COVID-related information. Kim Giles, Le Bonheur’s director of Decision Support, has watched these clinical registries add COVID variables to the information collected.

This allows the opportunity to evaluate COVID-19’s impact in critical care and corresponding interventions and therapies. It is also valuable to evaluate the effect on high-risk and complex patient populations, such as transplant patients, and diagnosis-specific cohorts, such as children with diabetes and similar chronic conditions.

“This data collaboration is vital to evaluate the impact of COVID-19 on children’s hospitals and advocate based on the national impact,” said Giles.

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