¶¶ÒõÂþ»­

Confronting COVID-19

Clinical trial nurses facilitate potential COVID-19 treatment for high-risk children

The COVID-19 pandemic has brought a new meaning to the phrase “all hands on deck” in the health care realm. And this is no different for the nurses, physicians and staff working to bring potential COVID-19 treatments to children through clinical trials. Le Bonheur serves as a site for a clinical trial of Regeneron’s REGEN-COV® (casirivimab and imdevmmab), a monoclonal antibody cocktail being investigated for use i high-risk children with mild to moderate COVID-19 symptoms.

When Le Bonheur was presented with an opportunity to bring REGEN-COV® to children in a clinical trial, Le Bonheur Clinical Trial Nurses Sarah Barve, RN, BSN, CNRN, Laura V. Boywid, BSN, RN, and Brandy Vaughn, BSN, RN, answered the call adding to their regular responsibilities to make this trial a reality. While all started their careers at Le Bonheur as nurses on the hospital floor, they are now in positions as research coordinators for clinical trials with the responsibility of providing the crucial infusion for COVID-19 patients.

“Working in clinical trials you get more one-on-one time with the family,” said Vaughn, a neurosurgery research coordinator who took up the mantle to help with the REGENCOV ® clinical trial. “Kids who have extensive medical history can get very sick from COVID. It’s rewarding to see over the course of the next weeks how they improved and stayed out of the hospital.”

REGEN-COV® is just one of many treatments undergoing clinical trials through Le Bonheur’s Children’s Foundation Research Institute. While children with COVID-19 are less likely to develop severe illness compared to adults, some children do suffer severe illness and more data is needed to determine how they respond to available treatments. Children with a wide variety of pre-existing medical conditions are a vulnerable population. If infected, they are more at risk to experience severe symptoms that can lead to hospitalization.

“Through this study, our goal is to be able to provide a medication to reduce or prevent hospitalizations due to COVID-19, particularly for patients who are higher risk,” said Lauren Davis, BS, clinical research coordinator for the REGEN-COV® study. “The safety of patients is the primary focus of the study team and patient participation is always voluntary. But in order to have new treatment options, it is important to have clinical trials to further advance medicine.”

The study focuses on children ages 0 to 17 years with at least one risk factor, such as heart and lung disease or obesity, who have tested positive for COVID-19 within the last three days. There is no placebo arm in this study — all patients enrolled receive a REGEN-COV® infusion.

In this study, REGEN-COV® will be given as a one-time infusion via an IV. The infusion lasts for two hours and is followed by a two-hour observation period during which vital signs are recorded. To track the effectiveness of the medication, lab work, such as nasal swabs and blood samples, are collected before and after the infusion. Follow up occurs in approximately five months, beginning with clinic visits weekly for a month and phone call follow up for five months after the infusion.

Boywid and Vaughn are with patients every step of the way in the process from screening to performing the infusion.

“As coordinators we serve in multiple roles,” said Boywid.

“We are part of actual administration of the medication and care throughout the infusion, but we also pre-screen, obtain consent and conduct follow ups with patients.”

They also play an important role in dispelling parents’ fears surrounding clinical trials and any concerns about safety.

“Our job as nurses is to be a patient advocate, part of which is patient safety,” said Vaughn. “When I talk to parents who are concerned, I tell them that patient safety is our priority. As a parent I would never put a child in a position where they aren’t safe. We spend as much time with them as they need to feel fully informed.”

But a successful study can’t take place without the help of an entire team. All pieces of the puzzle have to work closely together and in constant contact in order for timing of infusion and follow-up to be perfect, says Vaughn. This means close coordination among nurses, clinical research coordinator, principal investigator for the trial (Le Bonheur Chief of Pediatric Infectious Diseases Sandra Arnold, MD) and other areas of the hospital such as the IV team, pharmacy and lab.

Donors are another key component in bringing these new therapies to the children who need them. Whether COVID-19 or epilepsy research, clinical trials rely on donor funding to make these dream treatments a reality.

“Research at Le Bonheur is growing — we are starting up multiple new clinical trials across different specialties that require an abundance of resources,” said Davis. “We truly appreciate the donor support for helping us to accomplish this task.”

Epilepsy Exploration

Neurology clinical trial nurse manages trials for genetic epilepsy

For children with severe epilepsy and seizures who haven’t responded to medication, clinical trials can provide an avenue of hope.

Le Bonheur Nurse Sarah Barve, RN, BSN, CNRN, works to help families find that hope in her role as a pediatric neurology clinical research coordinator.

“Clinical trials provide potential treatment options for patients who have exhausted all other resources and still can’t get their seizures under control. Research is vital to be able to manage diagnoses like this,” said Barve.

Just one of these neurologic diseases in need of a treatment is Dravet syndrome, a rare genetic epilepsy that causes seizures and developmental delays. Previously, Dravet syndrome could only be managed by treating the symptoms, but thanks to a new clinical trial, the MONARCH study, Le Bonheur can offer a potential therapy to address the genetic cause of Dravet syndrome.

This is the first disease-modifying treatment option to be studied for Dravet syndrome. And preliminary data from the MONARCH study shows promise with no safety concerns in the study drug and a trend toward reduction in convulsive seizure frequency among patients.

“Through the MONARCH study, I will work with families for years. I get to learn everything about the patient and family, grow a unique bond and see improvements in the patient, and that’s why we do this work,” said Barve.

Clinical trials, including the MONARCH study, are conducted through the Children’s Foundation Research Institute — a collaboration among Le Bonheur, the University of Tennessee Health Science Center (UTHSC) and the Children’s Foundation of Memphis. Because of the complexity of the study, Barve shares responsibility as research coordinator with Misha Webb, RN, a veteran nurse with two decades of service at Le Bonheur.

But long before a clinical trial like MONARCH reaches patients, the trials and the medication they test have already undergone extensive scrutiny, research and approval processes. All clinical trials conducted at Le Bonheur are first approved by the U.S. Food and Drug Administration (FDA) and then by the Institutional Review Board (IRB) at the UTHSC. The IRB’s sole purpose is to protect the rights and well-being of patients participating in research.

Barve walks with children each step of the way as they participate in a clinical trial. Working in the health care field since age 18, Barve has been on both sides of the clinical trial divide — as a nurse on the critical care floor and working with a company that sponsored research studies. But she continued to miss patient care, which drew her back to Le Bonheur as a clinical trial nurse where she gets the best of both worlds — conducting research while also caring for patients and watching them improve. And now she is working toward a dual doctor of philosophy in Nursing Science and doctor of nursing practice at UTHSC with the long-term goal of conducting research at bedside.

A day as a research nurse is quite variable and covers a wide range of tasks associated with enrolling and treating patients and making sure administrative details are taken care of.

When a patient comes for a clinical trial visit, Barve stays with the family, documents tasks completed and collaborates with multiple departments in the hospital to ensure everything runs smoothly. When not with patients, Barve continues her work on clinical trials reviewing study protocols, making submissions to the IRB and meeting with study sponsors.

“This position gave me the opportunity to build a connection with the patients and family. Observing the efficacy of an investigational product first-hand is one of the most rewarding parts of this role,” said Barve. “To hear from the patient or parents that symptoms of a disease are improving brings so much joy to our team.”