First, he became an intern in the regulatory and compliance office with research at Norton Healthcare. Second, he decided to enlist in the Kentucky Army National Guard. Making these decisions allowed him to serve not only his community, but his country too. He also had a goal in mind: becoming the first military officer in his family. Five years later, Kendrick, a clinical research coordinator at Norton Healthcare, is also an officer in the Kentucky Army National Guard.

In May 2024, Kendrick learned that he was being deployed to support a unit in the Middle East in two weeks.

Chandler Render, also a clinical research coordinator; Marti Gardner, system director for clinical research operations; and Avery Davenport, a clinical research manager; were among the first that Kendrick told. And each of them sprang into action to make sure Kendrick had the support he needed.

“We wanted to make sure that while Kendrick was overseas, he had no worries or thoughts about his job,” Marti said.

Marti and Avery made sure Kendrick knew that his job at Norton Healthcare was never in jeopardy while he was deployed. They made sure his job duties were covered and worked with human resources leaders to ensure resources (like our Veterans ERG, HR support, and retraining programs) were available to Kendrick upon his return, gave reassurance they were not looking to replace him. They even ensured his computer would not be locked when he returned.

“He is already under enough stress while protecting our country, so we did what we could to lift some weight off his shoulders,” Avery said.

Chandler did similar things as a co-worker, but also took it further as Kendrick’s friend. Chandler remembered when her stepdad was deployed and he wouldn’t stop talking about everything he missed from back home while overseas. She made sure Kendrick had everything he needed by putting together care packages to send him. He had limited time to talk to friends and family, so she made an Amazon wish list so everyone could pitch in to make sure he was reminded of home.

Kendrick, who was in Jordan for two weeks, then Kuwait for four months, spoke about how much that meant to him.

“There was a 12- to 14-hour time difference. I only had two to three hours to speak with people from back home. When you are over there, you start to miss home, because life goes on there without you. The phone call check-ins and care packages kept me going — gave me a reminder of what I was protecting,” Kendrick said. “I really appreciated it.”

Chandler also helped watch Charli, Kendrick’s dog. It was an added layer of comfort knowing his best friend was watching over his other best friend. He could do his job with the Army without worrying about anything back home.

This gave Kendrick an idea — to nominate Norton Healthcare for the Patriotic Employer Award from Employer Support of the Guard and Reserve (ESGR) — a Department of Defense office. The award is presented to employers who go the extra mile to protect the job of military service members who are deployed. Only a few employers win recognition every year, and this year’s have not been announced. Meanwhile, Kendrick nominated Chandler, Marti and Avery for the Patriot Award. This award goes to individuals who provided support directly to military members like Kendrick and his family. Kendrick said it was a thank-you for everything they did for him. It was his first deployment, and his team made sure he felt comfortable leaving and returning, while simultaneously sending him encouragement while on deployment and allowing him to do his duty with little to no worries.

He kept it a secret, and surprised Chandler, Marti and Avery with the award presentation by Kendrick and a member of the ESGR during a department holiday party in late December 2024. 

“When you come to work, you bring your whole self — which includes things that happen off the clock. Norton Healthcare supports that work-life balance and understands that things impact you from other aspects of your life. It is important to know what is happening in your employees’ lives,” Marti said. “It helps form a respectful and open relationship. It all goes back to our mission, vision, values and culture.”

According to Avery, initiatives like VETS (Veterans Engaging Through Service), Norton Healthcare’s employee resource group for military veterans, make it easier to lean on others so leaders and colleagues don’t have to shoulder the support alone.

“When you are called to serve, the last thing you want to be thinking about is whether or not you’ll still have a job,” Kendrick said. “I’ve never worried about that with Norton Healthcare, from the moment I enlisted they were there to support me every step of the way.”

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The trial principal investigator is Tianhong Li, M.D., Ph.D., of the University of California, Davis Comprehensive Cancer Center. OncoC4 Inc. enrolled its first patient under the care of site investigator John T. Hamm, M.D., of Norton Cancer Institute in Louisville, Kentucky.

“It is very exciting to be part of this journey,” Dr. Hamm said. “As oncologists, we know we need better answers, and through clinical trials like this, especially in the past five years, we have seen rapid improvements in cancer care and treatment.” 

The Phase 1 ONC-841 clinical trial (NCT06352359) will study the medicine given by IV infusion to  patients with advanced/metastatic solid tumors, meaning various types of cancer that have spread beyond the cancer’s primary site, with a goal of reducing the tumor size and slowing the spread.

Norton Cancer Institute works through Norton Research Institute for clinical trials. Norton Research Institute has roughly 750 research studies currently underway, investigating medications, devices, outcomes, disparities and biology in multiple medical specialties. Of those, more than 100 are open clinical trials specific to cancer and 34 are Phase 1, which tests the safety, side effects, dosing and timing of a new treatment.

Dr. Hamm’s current clinical trials and studies

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The first area of research moving into the space will investigate the connection between gut biology and the onset of several memory and movement disorders, including Parkinson’s disease as part of Norton Neuroscience Institute Cressman Parkinson’s Research. The group’s hypothesis is that changes in the gut’s biology can affect the progression of these cognitive diseases.

“We know how debilitating cognitive disorders like Parkinson’s and Alzheimer’s diseases are for patients and their families,” said Steven T. Hester, M.D., MBA, senior vice president and chief clinical and strategy officer, Norton Healthcare. “By establishing this research laboratory, it shows Norton Research Institute’s commitment to expanding our efforts both at the bench and the bedside. In other words, we are looking at taking basic scientific knowledge and turning it into something that can directly benefit patients.”

Efforts in the new laboratory will be led by Shirish S. Barve, Ph.D., chief research scientist, Norton Neuroscience Institute and Norton Research Institute, who is known internationally for his research on the connection between the gut microbiome and brain. His work has received sustained federal funding from the National Institutes of Health.

Besides wet bench laboratories, lab support space and state-of-the-art equipment, the highlight of the new facility is an eight-freezer biorepository capable of sorting, storing and analyzing hundreds of thousands of bio specimen for use in research, investigating the gut-brain connection.

“We know the gut is constantly influenced by lifestyle issues, including lack of sleep, stress and diet,” Dr. Barve said. “We want to understand these changes and their connection to the neuroinflammation and neurodegeneration that can lead to neurological disorders such as Parkinson’s and Alzheimer’s diseases. We are hopeful this will lead to the development and implementation of evidence-based preventative and therapeutic strategies that will significantly and positively impact patient care.”

Funding for the lab and technology was made possible with a $4.2 million grant from the Norton Healthcare Foundation, with support from the estate of Elizabeth Pahk Cressman, M.D., Ph.D., respected anesthesiologist and philanthropist.

Over her lifetime, Dr. Cressman donated more than $28 million to Norton Healthcare in support of critical care and the neurosciences. Her gifts have created greater access to medical expertise, expanded innovative clinical translational research and helped recruit, train and attract best-in-class specialists.

“Because of this space, our specialists are going to be able to conduct groundbreaking research that is going to change lives,” said Lynnie Meyer, R.N., Ed.D., FAHP, CFRE, senior vice president and chief development officer, Norton Healthcare. “We’re grateful to Dr. Cressman’s vision and, with the community’s ongoing support, look forward to working to change the narrative around diseases that affect so many in our community.”

Norton Research Institute has roughly 750 research studies currently underway, investigating medications, devices, outcomes, disparities and biology in multiple medical specialties. In 2023, researchers participated in studies reported in 167 publications across pediatrics and adult research.

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Current studies encompass all phases of research, including investigating medications, devices, health outcomes, health disparities and developmental biology within areas that include Norton Cancer Institute, Norton Heart & Vascular Institute, Norton Infectious Diseases Institute, Norton Neuroscience Institute, Norton Leatherman Spine, Norton Orthopedic Institute, Wendy Novak Diabetes Institute and more. Researchers were involved in more than 360 published articles in 2022.

A new area of research announced as part of Norton Research Institute is Cressman Parkinson’s Research.

“We know that research many times leads to new treatments, medications or medical devices,” said Steven T. Hester, M.D., MBA, senior vice president and chief clinical and strategy officer, Norton Healthcare. “By establishing Norton Research Institute, we see opportunities to expand our efforts from the bench to bedside. In other words, we are looking at taking basic scientific knowledge and turning it into something that can directly benefit patients.

“This model will be evident most immediately within Cressman Parkinson’s Research,” he said.

Funding to create Cressman Parkinson’s Research is part of a rapid expansion in this field and will be key to building knowledge in this important area. Nearly 1 million people in the United States have Parkinson’s disease, according to the Parkinson’s Foundation, and incidence rates are increasing.

Initial support of $4 million for the program was provided by the Norton Healthcare Foundation. Efforts will be led by Shirish S. Barve, Ph.D., chief research scientist, Norton Neuroscience Institute and Norton Research Institute, who is known internationally for his research on the connection between the gut microbiome and brain. This work has already received additional sustained federal funding from the National Institutes of Health.

“We know that the gut is constantly influencing lifestyle issues, including lack of sleep, stress and diet,” Dr. Barve said. “We want to understand these changes and their connection to the neuroinflammation and neurodegeneration that can lead to disorders such as Parkinson’s disease and even Alzheimer’s disease. We are hopeful this will lead to better treatments for these disorders.”

Cressman Parkinson’s Research, a part of Norton Neuroscience Institute, was named in memory of Elizabeth Pahk Cressman, M.D., who donated millions of dollars in her lifetime to support Parkinson’s disease and critical care initiatives at Norton Healthcare.

“The kind of support given by Dr. Cressman and other donors is key to helping us advance research that will provide new treatments and hope for patients,” said Lynnie Meyer, Ed.D., R.N., CFRE, senior vice president and chief development officer, Norton Healthcare. “The Norton Healthcare Foundation is committed to helping advance knowledge and give our community access to the latest therapies.”

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available and help others by contributing to medical knowledge.

“We know that clinical studies and unique research partnerships can improve patient care, outcomes and quality of life,” said Stephen W. Wyatt, DMD, MPH, chief research executive, Norton Research Institute. “During the COVID-19 pandemic, we saw increased attention on research as the world looked for effective vaccines and treatments.”

Norton Healthcare researchers participated in 20 different COVID-19 trials. Norton Healthcare was the top enrolling site in the world for three of those. “This is a monumental time for research across Norton Healthcare,” Dr. Wyatt said. “We’ve already seen expansion of research in oncology, neurosciences, infectious diseases, diabetes, health equity and population health, and expect that momentum to continue.”

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Current studies encompass all phases of research, including investigating medications, devices, health outcomes, health disparities and developmental biology within areas that include Norton Cancer Institute, Norton Heart & Vascular Institute, Norton Infectious Diseases Institute, Norton Neuroscience Institute, Norton Leatherman Spine, Norton Orthopedic Institute, Wendy Novak Diabetes Institute and more. Researchers were involved in more than 360 published articles in 2022.

A new area of research announced as part of Norton Research Institute is Cressman Parkinson’s Research.

“We know that research many times leads to new treatments, medications or medical devices,” said Steven T. Hester, M.D., MBA, senior vice president and chief clinical and strategy officer, Norton Healthcare. “By establishing Norton Research Institute, we see opportunities to expand our efforts from the bench to bedside. In other words, we are looking at taking basic scientific knowledge and turning it into something that can directly benefit patients.

“This model will be evident most immediately within Cressman Parkinson’s Research,” he said.

Funding to create Cressman Parkinson’s Research is part of a rapid expansion in this field and will be key to building knowledge in this important area. Nearly 1 million people in the United States have Parkinson’s disease, according to the Parkinson’s Foundation, and incidence rates are increasing.

Initial support of $4 million for the program was provided by the Norton Healthcare Foundation. Efforts will be led by Shirish S. Barve, Ph.D., chief research scientist, Norton Neuroscience Institute and Norton Research Institute, who is known internationally for his research on the connection between the gut microbiome and brain. This work has already received additional sustained federal funding from the National Institutes of Health.

“We know that the gut is constantly influencing lifestyle issues, including lack of sleep, stress and diet,” Dr. Barve said. “We want to understand these changes and their connection to the neuroinflammation and neurodegeneration that can lead to disorders such as Parkinson’s disease and even Alzheimer’s disease. We are hopeful this will lead to better treatments for these disorders.”

Cressman Parkinson’s Research, a part of Norton Neuroscience Institute, was named in memory of Elizabeth Pahk Cressman, M.D., who donated millions of dollars in her lifetime to support Parkinson’s disease and critical care initiatives at Norton Healthcare.

“The kind of support given by Dr. Cressman and other donors is key to helping us advance research that will provide new treatments and hope for patients,” said Lynnie Meyer, Ed.D., R.N., CFRE, senior vice president and chief development officer, Norton Healthcare. “The Norton Healthcare Foundation is committed to helping advance knowledge and give our community access to the latest therapies.”

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available and help others by contributing to medical knowledge.

“We know that clinical studies and unique research partnerships can improve patient care, outcomes and quality of life,” said Stephen W. Wyatt, DMD, MPH, chief research executive, Norton Research Institute. “During the COVID-19 pandemic, we saw increased attention on research as the world looked for effective vaccines and treatments.”

Norton Healthcare researchers participated in 20 different COVID-19 trials. Norton Healthcare was the top enrolling site in the world for three of those.

“This is a monumental time for research across Norton Healthcare,” Dr. Wyatt said. “We’ve already seen expansion of research in oncology, neurosciences, infectious diseases, diabetes, health equity and population health, and expect that momentum to continue.”

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“For the most part, RSV attention has been focused on children,” said Julio A. Ramirez, M.D., FACP, chief scientific officer, Norton Infectious Diseases Institute. “But some studies have suggested that up to 10% of adults with respiratory illness have RSV.”

The study, which is funded by Pfizer, will look at some of the best ways to identify RSV in adults. The long-term goal is to determine which adults are most impacted.

Patients ages 40 years and older who are experiencing respiratory symptoms and admitted to one of Norton Healthcare’s four adult-service hospitals in Louisville are invited to participate in the study. Once enrolled, nasopharyngeal, saliva, sputum and blood samples will be collected.

Symptoms of a mild RSV infection are very similar to a cold, including congestion and runny nose, cough, low fever, sore throat, headache and sneezing. In serious cases, RSV may lead to wheezing, difficulty breathing, higher fever, more severe cough and even bluish skin, indicating low oxygen levels. RSV also can cause pneumonia, bronchiolitis and congestive heart failure. Breathing often is most affected.

RSV also may play a part in making underlying chronic health conditions worse, including cardiovascular, pulmonary, metabolic and immune systems conditions.

“The majority of adults who get RSV have very minor symptoms,” said Ruth Carrico, Ph.D., DNP, APRN, FNP-C, CIC, FSHEA, FNAP, FAAN, director of research operations, Norton Infectious Diseases Institute. “But severe cases do occur in adults.”

RSV is a virus, and cannot be treated effectively with antibacterial agents. Instead, people with RSV usually are given supportive care similar to treating a cold or fever. In serious cases, this includes fluids and oxygen, and possibly a ventilator.

Norton Infectious Diseases Institute was chosen for this study because of the team’s depth of experience in clinical research. The team began enrolling patients in December 2021 and has more than 300 patients participating to date. The goal is to enroll up to 3,000 individuals over the course of the next two RSV seasons, which generally run November through April.

About the research team

Julio A. Ramirez, M.D., FACP, is chief scientific officer for Norton Infectious Diseases Institute, a part of Norton Healthcare, in Louisville, Ky., and professor of medicine at the University of Louisville School of Medicine. He’s also a fellow of the American College of Physicians. He is board certified in internal medicine and holds subspecialty certification in infectious diseases.

Dr. Ramirez’s areas of clinical and translational research include pneumonia, influenza and emerging respiratory pathogens. His research activities have received funding from the Centers for Disease Control and Prevention (CDC), U.S. Department of Defense and the National Institutes of Health. Dr. Ramirez has been published in more than 250 peer-reviewed publications, and he is a reviewer for several journals, including the New England Journal of Medicine and Annals of Internal Medicine. Dr. Ramirez currently serves as the section editor on pulmonary infections for the evidence-based clinical decision support tool “UpToDate.”

Dr. Ramirez served as a member of the American Thoracic Society (ATS) committee for the development of national guidelines for the management of community-acquired pneumonia and, more recently, on the ATS International Task Force on COVID-19, which published guidelines for the management of COVID-19. He also served as a member of the U.S. Food and Drug Administration advisory committee for the approval of anti-infective drugs. Dr. Ramirez is the recipient of the 2013 European Respiratory Society Presidential Award in recognition of his outstanding contribution to research in the field of respiratory infections.

Ruth Carrico, Ph.D., DNP, APRN, FNP-C, CIC, FSHEA, FNAP, FAAN, is director of research operations for Norton Infectious Diseases Institute. She is a family nurse practitioner and gratis faculty professor with the University of Louisville School Medicine Division of Infectious Diseases. Dr. Carrico has received training specific to health care epidemiology at the Centers for Disease Control and Prevention (CDC) in conjunction with the Emory University Rollins School of Public Health, Atlanta, Georgia, and Society for Healthcare Epidemiology of America.

Dr. Carrico has been on numerous boards and held numerous positions with infectious diseases societies and organizations, including APIC Text of Infection Control and Epidemiology, the CDC National Biosurveillance Subcommittee Advisory Committee to the Director and the CDC’s Healthcare Infection Control Practices Advisory Committee. In October 2021, Dr. Carrico was inducted as a fellow of the American Academy of Nursing, the highest honor in the nursing profession. Her practice and research activities involve infectious diseases, infection prevention and control, vaccinology and international travel medicine.

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The Phase 3 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of a single vaccine dose of the Janssen investigational COVID-19 vaccine candidate versus placebo, in approximately 60,000, including significant representation from those that are over 60.

Janssen’s investigational COVID-19 vaccine leverages Janssen’s AdVac® technology. The same technology was used to develop Janssen’s European Commission-approved Ebola vaccine regimen and is the basis for its HIV, RSV and Zika vaccine candidates. To date, more than 100,000 individuals have been vaccinated with a Janssen AdVac®-based vaccine.

The UK, Baptist Health Lexington and Norton Healthcare research teams plan to enroll at least 2,000 local volunteers for the trial, which is open to people over 18 who meet inclusion criteria, including adults with and without other health issues associated with an increased risk for progression to severe COVID-19. UK’s Dr. Richard Greenberg, an infectious disease expert with four decades of experience in vaccine development, leads this local effort.

“Service to our Commonwealth is why UK was created. We are doing everything we can to respond and intervene against this pandemic, now including leading a vaccine clinical trial. We are proud of this opportunity to work with our communities—especially those most impacted—in efforts to contribute to the fight against COVID-19,” said UK President Eli Capilouto.

Janssen has also joined other pharmaceutical companies in making a pledge to the world that it will continue to adhere to its high scientific, ethical and regulatory standards and will rely on robust clinical evidence to guide the development of its investigational COVID-19 vaccine candidate. Janssen is committed to transparency and sharing information related to the Phase 3 ENSEMBLE study – including the study protocol.

Greenberg, the principal investigator for the study, brings extensive expertise to the trial. His history in vaccine development includes serving in Bihar, India for the successful effort by the World Health Organization to eradicate smallpox, leading a cooperative shingles prevention study with the VA here in Lexington, and working in a partnership with the military to develop vaccines for plague, botulism, and smallpox. He has led more than 28 vaccine trials and published more than 150 peer reviewed papers.

“The most important effort to end this pandemic requires the cooperation and participation of many scientists, doctors, public health leaders, politicians, and the people of the world,” Greenberg said.

“To have a chance to be a small part of the solution is not only an opportunity for the university but an honor for me. And I thank the many people working so hard at all levels of this project—from those behind the scenes to all of our volunteers—because they know how important this is to the world.”

Individuals interested in learning more about participating in the trial in the Louisville area can visit NortonHealthcare.com/COVIDstudy to find more information and answer a pre-screening questionnaire, after which the research team might contact them to determine if they are eligible.

Qualified participants will be compensated. All information is confidential, and answering the questionnaire does not obligate you to join the study.

Additional information is available at Janssen’s ENSEMBLE website.

At UK, the trial is organized and implemented through the infrastructure of the Center for Clinical and Translational Science (CCTS), whose mission is to accelerate discoveries that improve health.

The CCTS also serves as the coordinating center for all three sites.

“The Center for Clinical and Translational Science is devoted to the stimulation of innovation, through the support of high-quality translational research, with an emphasis on team science, workforce development, and community engagement. COVID-19 is an urgent and critical public health crisis, and UK’s participation in this trial would not be possible without the CCTS infrastructure. We are proud and eager partners with Dr. Greenberg,” said Dr. Philip Kern, CCTS director.

The Baptist Health Lexington arm of the study is led by Dr. David Dougherty, infectious disease specialist and principal investigator, along with a clinical research team.

“We are proud to partner with other providers to bring the latest innovations in healthcare and wellness to our communities,” said William G. Sisson, president of Baptist Health Lexington.

In Louisville, the Norton Healthcare arm of the study is led by infectious disease specialist and system epidemiologist Dr. Paul Schulz.

“Norton Healthcare has one of the largest community healthcare system-based research portfolios in the country, and we know our employees and members of the community will step up to this opportunity to participate,” Dr. Schulz said.

ENSEMBLE is being initiated in collaboration with the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Other Transaction Agreement HHSO100201700018C.

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“This is exciting because we’re trying to provide an early intervention to prevent progression of COVID-19,” said Joseph M. Flynn, D.O., MPH, FACP, principal investigator for the study and chief administrative officer, Norton Medical Group, and physician-in-chief, Norton Cancer Institute. “This has great implications for long-term care facilities and the many at-risk individuals who remain in a difficult position.”

To be eligible for the clinical trial, hospitalized COVID-19-positive patients must be considered high risk and have markers of inflammation present in their bloodwork. A patient is considered high risk if they are over age 65 or have an underlying medical condition, including cancer, cardiovascular disease, lung issues or high blood pressure. Those who currently use tobacco also may be candidates. To determine effectiveness, researchers will look at changes to respiratory rate, blood oxygen saturation, SARS-CoV-2 antibody levels and changes in bloodwork.

The study is funded with a $50,000 grant from the Norton Healthcare Foundation. It is the first time that Norton Healthcare has been the origin of a Food and Drug Administration-approved, investigator-initiated clinical trial.

“This new trial has been established with the goal of collecting data that will help us determine if this therapy works for this particular population of patients,” Dr. Flynn said.

In the Louisville, Kentucky, area, Norton Healthcare was the first to take part in a clinical trial to evaluate the use of convalescent plasma to help critically ill patients. Over 160 patients have received plasma since April as part of this study. It was part of a larger Mayo Clinic expanded access study that was not developed to examine effectiveness of the plasma, but to help patients and collect data.

That initial trial laid the groundwork for this new trial with data collection in mind. Norton Healthcare developed a robust convalescent plasma donor program, and that has allowed the organization to undertake this new study. The program also is being used by plasma collection centers around the country.

“We had a well-developed process for contacting patients who had recovered from COVID-19; and because of their willingness to donate their plasma, we are able to begin this trial,” Dr. Flynn said. “We continue to work with potential donors, and it is our hope that together we will save many peoples’ lives and prevent critical illness.”

Normally it takes months to get clinical trials opened.

“With the hard work of many, both inside the Norton Healthcare Research Office and outside of it, we were able to open this study in just weeks,” said Stephen Wyatt, DMD, MPH, chief research executive, Norton Healthcare. “In fact, since COVID-19 began to significantly impact  our area, we have been able to bring several clinical trials to Louisville with the hope of helping patients and expanding the science-base around treatments that impact COVID-19.”

Norton Healthcare was the first in the world to enroll COVID-19 patients in three clinical trials. These are for the drugs selinexor, APL-9 and acalabrutinib.

The Norton Healthcare Research Office helps to bring new medical advances to our community and to medical professionals and patients throughout the world. During the first quarter of 2020, the research office had more than 1,000 active and pending clinical research studies supporting a full scope of health care services, including 11 pending studies to fight COVID-19.

Norton Healthcare’s clinical trials program is the most robust community health care system-based program in the Louisville and Southern Indiana area, and has been instrumental in the development of many drugs and medical devices. In addition to COVID-19, Norton Healthcare clinical trials include emerging treatments for cancer, cardiovascular issues, neurological conditions, orthopedic conditions, maternal-fetal medicine and more.

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To date, many of the medications used to combat the coronavirus have been used to treat cancer, however additional therapies and drugs are emerging as potential treatment options for COVID-19 and the side effects caused by the disease.

“I am incredibly proud of our clinicians and researchers for leading the way in our community to combat this pandemic,” said Steven T. Hester, M.D., MBA., division president, provider operations, and chief medical officer, Norton Healthcare.

RELATED: What has COVID-19 taught us about ‘getting sick’?

Lung inflammation

In late May, Norton Healthcare researchers, led by Michael F. Driscoll, M.D., medical oncologist with Norton Cancer Institute, were the first in the world to begin a study to evaluate the safety and effectiveness of APL-9 in adults with mild to moderate acute respiratory distress syndrome (ARDS) caused by COVID-19 who are hospitalized and require supplemental oxygen therapy with or without mechanical ventilation.

It is thought that COVID-19 activates the complement system, part of the immune system that responds to infection or tissue damage, and increases inflammation in the lungs. APL-9 is a drug designed to inhibit or block activation of part of the complement pathway and potentially reduce inflammation in the lungs.

Immune response and inflammation

oncologist, and colleagues with Norton Cancer Institute, are the first in the world to enroll a patient in a trial of acalabrutinib. In certain cancer patients, this drug is used to block a protein called bruton tyrosine kinase (BTK), which contributes to cancer cell growth and survival. When BTK is inhibited, researchers look to see if a person’s immune response is enhanced and inflammation is blocked.

This trial with COVID-19 patients will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with best supportive care in the treatment of COVID-19.

Another medication trial will begin soon on a new compound called TL-895. This is an oral tyrosine kinase inhibitor which is used in cancer care to help block the growth of an enzyme which can cause cancer cells to grow. This study will be led by Don A. Stevens, M.D., medical oncologist with Norton Cancer Institute. Norton Healthcare is one of only a few sites selected to participate.

Dr. Stevens also led recent studies on convalescent plasma and cancer drug selinexor. In early April, Norton Healthcare began a clinical trial to evaluate the use of convalescent plasma in treating patients with severe cases of COVID-19. That trial has since been expanded to include patients with less severe cases. Nearly 70 patients have received the plasma.

Cardiovascular injury

Another study is looking at treating cardiovascular injury from COVID-19. Kelly C. McCants, M.D., cardiologist and medical director of the Norton Heart & Vascular Institute Advanced Heart Failure and Myocardial Recovery Program, is leading a trial in collaboration with Octapharma and BioMatrix SpRx to look at the effect of intravenous and subcutaneous immunoglobulin in treating cardiovascular injury.

“While acute lung injury and pulmonary edema are feared COVID-19 complications, many patients present with elevated cardiac biomarkers and evidence of left ventricular dysfunction,” Dr. McCants said.

COVID-19 treatment research at Norton Healthcare

Norton Healthcare has been an international leader in the fight against the coronavirus, which causes COVID-19. The established history of scientific excellence has allowed Norton Healthcare physician scientists to bring important new treatments and diagnostic tools to the region. Researchers with expertise in experimental therapeutics and drug development have worked with industry leaders to ensure patients have access to the latest discoveries to battle COVID-19.

Norton Healthcare’s clinical trials program is one of the most robust programs in the region and has been instrumental in the development of many drugs and medical devices in a variety of areas. Norton Healthcare clinical trials include emerging treatments for cancer, cardiovascular issues, neurological conditions, orthopedic conditions, maternal-fetal medicine and more. For all trials, patients must meet certain eligibility criteria. For information, call the Norton Healthcare Research Office at (502) 629-3500.

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“Vaccines are basically a means to try to activate one’s own immune system to recognize the presence of cancer and eliminate it,” Dr. LaRocca said.

The phase 2 clinical trial for this vaccine was conducted by AIVITA Biomedical. Patients who were part of this all followed the same process:

• A blood sample was collected and submitted to be processed for antigen-presenting immune cells.
• Proteins from each patient’s tumor cell line were used to develop a specific vaccine personalized for that patient.
• AIVITA Biomedical shipped each patient’s prepared vaccine to Norton Cancer Institute, where it was administered at specific time points in addition to the patient’s standard treatment.

Initial trial results, released by AIVITA Biomedical in August 2019, suggest a significant decrease of tumor burden among study participants. Should this ultimately translate to survival, we will be honored to have been part of the work to move glioblastoma from largely untreatable to treatable.

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