For Catherine Gamas, it was a different story. Her symptoms were more severe and have lingered. She lost her senses of taste and smell and experienced extreme fatigue and confusion. Months after her diagnosis, the 56-year-old Clarksville, Indiana, resident still has intermittent loss of taste and smell, dizziness, daily headaches and hair loss and said she bruises easily.

“I would do one thing and have to sit down. I could go down the stairs but not back up,” she said. “The hair loss is most distressing. It used to take two hours for my hair to dry normally. Now it’s 15 minutes at best.”

Dale Josey, a Louisville resident and podcaster, also reported symptoms that disrupted daily routines. He developed lethargy and weakness, had painful joints and was extremely cold. He also experienced blinding headaches, nausea and loss of taste.

“It was too intense to eat,” he said.

To help researchers better understand these and other short- and long-term effects of COVID-19, Fritschner, Gamas and Josey are participants with the Post COVID-19 Research Clinic at the University of Louisville. They are committed to furthering knowledge of post-COVID-19 conditions by sharing their experiences to help UofL researchers learn more about how the disease affects people differently and hopefully improve treatment for others during and after the illness.

For Josey, participation in the research clinic is essential “to add to the body of scientific research.” For the same reason he regularly donates blood (7 gallons of lifetime donations), Josey is participating to improve the health of the Louisville community.

The UofL Division of Infectious Diseases created the multidisciplinary research clinic to study the wide variety of symptoms and effects of COVID-19.��Volunteer participants from Louisville and surrounding areas who previously were diagnosed with COVID-19 can participate in the research study to document and monitor their symptoms and health changes over time.

“We will conduct comprehensive mental and physical assessments to determine the many possible effects of COVID-19,” said T’shura Ali, a UofL postdoctoral associate who manages the research clinic. “We want to expand the knowledge of how the disease progresses, to help improve treatments and interventions – both when patients are initially sick and after – to define, measure and prevent the long-term effects of COVID-19.”

Post-COVID symptoms can be any change in quality of life, health status or symptoms that emerge after the infection. COVID-19 patients have reported a wide variety of symptoms weeks and months following their initial infections, but some of the most common include:

• Decreased cardiac function (fast-beating or pounding heart, heart palpitations, chest pains)
• Decreased lung capacity (difficulty breathing or shortness of breath)
• Joint or muscle pain
• Blood clotting issues
• Decline in mental health
• Intense migraines or headaches
• Fatigue
• Brain fog (difficulty thinking or concentrating)
• Continued loss of smell or taste

Participants for the study from Louisville and surrounding areas age 18 and over who have had COVID-19, confirmed by a diagnostic test, are eligible to participate in the study whether they have experienced long-term symptoms following infection or had no additional symptoms. Vaccination status does not affect eligibility.

Researchers will record study participants’ health history and all their COVID-19 symptoms and health changes over time. They will record vital signs, conduct physical examinations and administer validated health assessments, vision tests, lung function tests and electrocardiograms (EKG). Study participants also will be asked to provide blood and urine samples at each visit. The data will be analyzed by a group of experts led by Julio Ramirez, professor and chief of the Division of Infectious Diseases, including physicians and researchers in cardiovascular medicine, perioperative medicine, pulmonary care and critical care, as well as clinical and translational researchers.

To further study decreased heart and lung function, some of the most common and severe symptoms associated with COVID-19, Jiapeng Huang, professor in the Department of Anesthesiology and Perioperative Medicine, is conducting a sub-study of the research clinic’s participants, supported by Gilead Sciences.

“For this project, we will study the heart, lungs and blood vessels of individuals who have been ill with COVID-19 using ultrasounds done at the clinic.��This research will establish the foundation for future preventive and therapeutic strategies,” Huang said.

“These participants are helping to contribute to clinical care, research and science in understanding the burden of disease to help guide progress toward better treatment and care, which ultimately will improve the Louisville community’s overall health,” Ali said.

All appointments and tests are free for the participants. Information will be used for research purposes only and will remain confidential. The research clinic does not provide treatment or referrals, but abnormal findings will be reported to the participants. Study visits are conducted every three to six months and participants are followed for approximately one year.

To learn more, visit the division , email COVClinic@louisville.edu or call 502-852-8680.

The Phase 3 trial enrolls residents and staff who live or work at facilities that have had a recently diagnosed case of COVID-19 and who now are at a high risk of exposure. The study, which included Essex Nursing and Rehabilitation Center in Louisville recently, is to evaluate the efficacy and safety of bamlanivimab for the prevention of COVID-19. The study also is exploring treatment of recently diagnosed SARS-CoV-2- and COVID-positive patients who are at high-risk of developing severe disease.

As the only Kentucky location for the Phase 3 clinical trial, UofL’s Division of Infectious Diseases worked with mobile units deployed by Lilly to the Louisville site to enroll and treat trial participants. Julio Ramirez, director of the division, leads the work, which includes follow-up monitoring for study participants at this facility and any others in Kentucky who may participate in the trial.

“We are thrilled to be partnering with NIH and Lilly for the implementation of their BLAZE-2 study in Kentucky. With nearly 30,000 residents in long-term care facilities in the state, there is an urgent need for therapeutic strategies to prevent the spread of COVID-19 in this vulnerable population. We are proud to be a part of this new type of clinical study for preventive treatment,” Ramirez said.

For this trial, Lilly deploys mobile research units to a long-term care site soon after an individual has tested positive for SARS-CoV-2. The unit team enrolls residents and staff members who volunteer to participate in the trial. The one-time study drug infusion and follow-up visits are administered to study volunteers at the long-term care facility. The UofL team works with the Lilly team during the initial site infusions and will monitor participants following the infusion for up to 25 weeks.

The first deployment in Kentucky was to Essex Nursing and Rehabilitation Center, where 20 residents and staff members were enrolled in the study in November.

“Our elderly population is at a much higher risk of complications from COVID-19 and our staff and residents are happy to be participating in this study. I have personally witnessed the negative impact COVID-19 has had on nursing facilities,” said Robert Flatt, Essex administrator. “I am extremely proud to be an active participant in this collaborative study in the hopes that we will soon put an end to this pandemic.”

The virus is known to spread rapidly among staff and residents of long-term care facilities, who account for a high percentage of hospitalizations and deaths resulting from the virus.

“I am glad to be a part of this research study with the University of Louisville to help find treatment and prevention options for COVID-19. As a member of our community, I am happy to participate in the hopes of helping others. I am also excited to participate as I am a huge fan of the University of Louisville,” said Patricia L. Rollie, an Essex resident and study participant.

Antibodies are produced naturally by the immune system in response to viruses and other foreign invaders and help the body neutralize and destroy these threats. However, it takes time for the body to produce its own antibodies. Bamlanivimab is an antibody engineered from a COVID-19 survivor. Testing and previous trials have shown that manufactured antibodies can speed recovery or possibly prevent SARS-CoV-2 infection.

“COVID-19 has had a devastating impact on nursing home residents. We’re working as fast as we can to create medicines that might stop the spread of COVID-19 to these vulnerable individuals,” said Daniel Skovronsky, Eli Lilly’s chief scientific officer and president of Lilly Research Laboratories. ”BLAZE-2 is a first-of-its-kind COVID-19 trial designed to address the challenging aspects of running a clinical trial in long-term care facilities, which normally do not conduct clinical trials.”

As a result of a separate clinical trial, Lilly��has received an emergency use authorization from the FDA for bamlanivimab to treat higher-risk patients recently diagnosed with mild-to-moderate COVID-19.

Bamlanivimab targets the spike protein of the SARS-CoV-2 virus. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus and potentially preventing and treating COVID-19. Bamlanivimab emerged from the collaboration between��Lilly��and AbCellera and was discovered by AbCellera and scientists at the��National Institute of Allergy and Infectious Diseases��Vaccine Research Center.

The treatment, a new formulation of Aviptadil (RLF-100), produced by Pennsylvania-based NeuroRx and Relief Therapeutics Holding, SA, of Geneva, works by combating “cytokine storm,” an unchecked overreaction of the body’s immune response. These storms can cause severe lung inflammation and stiffening that make it difficult, if not impossible, for patients to breathe on their own.

“We want to mitigate these storms,” said the clinical trial lead, Dr. Rainer Lenhardt,�� associate professor of anesthesiology and critical care in the “We’re doing anything we can to improve outcomes.”

COVID-19 is primarily a respiratory disease and about 80% of cases are mild to moderate, . But in severe and critical cases, the lungs can swell and fill with fluid as the body tries to fight off the infection. This severe respiratory failure is a major cause of COVID-19-related death.

“These patients are terribly ill,” said Forest W. Arnold, an investigator on the clinical trial and an associate professor in the UofL Division of Infectious Diseases. “And because this virus is so novel, options for treatment are just now being developed. This gives us another option.”

In this Phase 2b/3 trial, UofL and other sites will treat at least 144 patients. To be eligible, participants must be patients at receiving intubation and mechanical ventilation due to COVID-19-induced severe respiratory failure. Phase 2 and Phase 3 trials determine effectiveness and monitor for adverse reactions. A list of other ongoing clinical trials at UofL is available .

The drug has previously been used for other indications, but in this formulation, it acts as an anti-inflammatory agent. The formulation is believed to protect alveolar type-2 cells in the lungs which are essential to oxygen exchange and are thought to be a major target of the SARS-CoV-2 virus.

In Phase 1 trials, designed to assess safety and dosage, seven of eight patients with acute respiratory distress caused by sepsis were taken off breathing machines after receiving the drug and six eventually left the hospital.

“Our No. 1 goal is to provide a potentially life-saving therapy to critically ill patients with COVID-19. The FDA has granted fast-track designation for RLF-100 underscoring the urgent need for new treatment options,” said Jonathan Javitt, CEO and chairman of NeuroRx. “We are excited to work with UofL and leverage its clinical research and infectious disease expertise to advance research in COVID-19.

Since the coronavirus pandemic began, UofL has taken a leadership role in investigating and developing innovative ways to prevent, diagnose and treat the virus. Researchers are working to block coronavirus from infecting human cells, launching groundbreaking initiatives for testing, building robots that can sanitize high-risk areas and more. If you are interested in supporting this or other COVID-19 research at UofL, contact Lisa Warner at lisa.warner@louisville.edu or visit .��

Infectious disease researchers at UofL are working with all 10 Louisville hospitals and two in southern Indiana, including UofL Health, Norton and Baptist, to process tests and study the illness in order to gather information needed to prevent transmission of COVID-19. Julio Ramirez, MD, chief of the Division of Infectious Diseases, and Ruth Carrico, PhD, RN, professor in the division, along with Donghoon Chung, PhD, and Kenneth Palmer, PhD, director of the Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases (CPM), have��developed a surveillance program to track the prevalence of the illness and which patients are most affected.��

“I think the big issue is understanding the emergence of this illness and the pandemic response in terms of where the cases are, how many cases we’re seeing and among what types of patients,” Carrico said. “This study will help us better understand risk factors and how we need to approach it from a preventive perspective,” Carrico said.

Because this virus is so new, health professionals do not have as much information about how the disease presents initially and how it progresses as they do about other diseases that have been studied for decades. They also still need a better understanding of how the virus, SARS-CoV-2, is spread. The work being done at UofL will help provide that knowledge.

“With the information we are gathering, we will better understand how transmission occurs. When we understand how transmission occurs, that provides us the tools we need to develop some effective interventions,” Carrico said.

The development of testing for this research has been led by researchers at the CPM, where Chung worked to establish and refine procedures for high-throughput testing of more than 350 clinical samples per day for the research.

This information is needed not only to protect the community, but to protect health care workers from becoming ill. In China and elsewhere, doctors and nurses contracted COVID-19 at high rates, which affected their availability to care for ill patients. The information gained through the surveillance program will be used to generate guidelines for real-time hospital and community education and response activities, reducing spread in hospitals and protecting health care workers on the front lines.

Over time, the surveillance project will reveal not only the current scope of the pandemic in Louisville and beyond, but will monitor the epidemic over weeks and months, allowing the researchers to predict the impact of the virus in the future.��

UofL has been designated the first Center of Excellence by Pfizer Vaccines.

“UofL’s Division of Infectious Diseases has a rich history of collaboration with Pfizer through the successful implementation of numerous clinical epidemiological research studies. We are excited to formalize a long-term collaboration that builds on these past successes,” said Julio Ramirez, MD, chief of the Division of Infectious Diseases at the .

The Center of Excellence, directed by Ramirez, is a collaboration between the university and the pharmaceutical corporation aimed at determining the human health burden of important infectious diseases and potential vaccine effectiveness. The data will provide robust evidence to national health officials and independent policy makers who develop recommendations for the use of vaccines in immunization programs worldwide. Studies will take place in hospitals, long-term care facilities and the community.

UofL is the first Center of Excellence selected by Pfizer Vaccines Medical Development and Scientific/Clinical Affairs to be part of an international network of epidemiological research organizations. This designation is for a period of three years with an option for renewal. Pfizer selected UofL because of the university’s exceptional capabilities for conducting population-based surveillance and clinical research that engages multiple health care facilities, health care personnel, industry and communities-at-large.

“Pfizer has had an outstanding working relationship with the University of Louisville for more than 10 years,” said Luis Jodar, PhD, chief medical and scientific affairs officer, Pfizer Vaccines. “The quality of disease burden evidence varies widely worldwide. Deriving accurate and credible population-based incidence estimates require comprehensive surveillance to identify cases of diseases within a well-defined and well-characterized geographic area. Thanks to UofL’s excellent network of research partners, the population available for research studies in Louisville can provide the data to derive estimates of disease burden that can be generalized nationally.”

The demographics of Jefferson County, Kentucky, are similar to the United States in general, including racial and ethnic make-up, socioeconomic status, and the proportion of rural and urban populations.

The research studies conducted as part of the center may lead to economic growth and development for the city of Louisville and the Kentuckiana region, including jobs and educational opportunities in the health care industry.

“This collaboration will provide increased visibility for the university on a global scale, making UofL attractive for high-caliber researchers and research grants,” said Neeli Bendapudi, PhD, president of UofL. ”It also presents an exceptional opportunity for our researchers to improve the human condition by helping to reduce the burden of infectious diseases worldwide by generating data that will inform governments and health care policymakers.”

Pfizer studies anticipated for UofL include population-based surveillance of infectious diseases including Streptococcus pneumoniae, a bacteria which causes pneumonia and other infections, Clostridioides difficile, a bacteria that causes severe diarrhea and colitis, and respiratory syncytial virus (RSV), a common virus associated with mild cold-like symptoms but can cause severe infection in some people, including older adults. Visit for additional information on these diseases and two Center of Excellence studies already underway at UofL:

• The City of Louisville Diarrhea (CLOUD) study launched in September 2019. Pfizer will be providing up to $6.5 million in funding for a one-year study of the incidence of diarrhea among Louisville-area residents.
• The Louisville Pneumonia study is up to $4.5 million in funding provided by Pfizer for a one-year study of the incidence of pneumonia among adults in Louisville that launched in November 2019.

Check out the video for more information:��

Myers and his team screened 82,243 individuals for HCV infection in 2016-2018 in Norton Healthcare in order to assess trends in a large health care system in an area with a high prevalence of opioid use and HCV infection. The investigators defined millennials as individuals born between 1980 and 1995, and baby boomers were those born between 1945 and 1965.

Traditionally, baby boomers were the largest drivers of HCV, though millennials have been shown in previous research to be the fastest-growing population of those infected with the virus. However, those studies were performed at single institutions with small sample sizes.

Millennials who were HCV-positive increased by 53 percent over the study period while the population of HCV-positive individuals among baby boomers decreased by 32 percent.

“The opioid crisis has led to a drastic demographic shift, and currently the typical HCV-infected individual is a younger male. Without interventions, this trend will continue for upwards of seven years, plateauing near the demarcation of millennials and generation Z,” Myers said.

The data were presented Oct. 3 in Washington at IDWeek, the combined medical meeting of four adult and pediatric infectious disease societies.��

The event, which is open to the public, will feature healthy food options from more than 20 different restaurants and local grocers, as well as a cash bar, live music from (blues, R&B, reggae, jazz), a silent auction and raffles.

Hosted by , the and the , the event will be held from 6-8 p.m. at the UofL Kosair Charities Clinical and Translational Research Building at 505 S. Hancock St. on the UofL Health Sciences Campus.

The cost of the event is $45 for members of the Kentucky Nurses Association, and $50 for others. The money will go toward scholarship funds, education and research at the , and some also will go to UofL Physicians – Infectious Diseases for vaccine supplies. The event also will feature a “Giving Tree.”��

“The event is a way for restaurants and the community to say ‘thank you’ to nurses for their efforts to mobilize and come to restaurants and vaccinate all workers against hepatitis A,” said , clinical director of the and an associate professor at the .

Nurses from UofL vaccinated around 6,000 people at restaurants in Louisville and Jefferson County. Hepatitis A is a highly contagious liver infection, most likely to be spread from contaminated food or water or from close contact with an infected person or contaminated object.

“It’s important to recognize their contribution to public health,” Carrico said. “It’s also important to realize what a resource UofL is, in that we have the ability to mobilize and respond to a public health crisis such as this.”

RSVPs are requested by July 20 by visiting the Kentucky Nurses Foundation site , or by calling the Kentucky Nurses Association office at 502-245-2843.

A ribbon-cutting and open house marked the UofL Hospital Hep C Center’s official opening Wednesday morning, with the first patients scheduled later in the day.

“While Kentucky has the highest rate of new hep C cases in the U.S., few places exist here for treatment,” said , a family nurse practitioner who specializes in gastroenterology and hepatology and who leads the center. “This is a much-needed service in the community.”

In the past, treating hepatitis C was difficult. It involved a triple therapy with interferons that lasted almost a year, with multiple side effects. Not everyone was a candidate for treatment. Doctors found it challenging, and some patients opted to not get treated at all.

“Many patients were scared off by treatment, knowing it was going to be hard,” Cave said. “Maybe they saw a friend go through it. But we want them to know it’s not hard anymore. We can help so many people.”

Today, treatment is one pill, once a day, for 8 to 12 weeks with minimal side effects, said , the center’s medical director and a gastroenterologist with the hospital and UofL Physicians. The center also uses FibroScan, which allows staff to perform a non-invasive assessment of the liver without a biopsy.

“This is truly a success story of modern medicine,” he said. “We went from discovering the basic science of the disease in the late ‘80s, early ‘90s, to finding a cure in 2014.”

Up to half of patients who have hepatitis C may not know they are infected, Cave said. The has recommended screening for all baby boomers.

“People may carry the disease for decades before they have symptoms,” she said.

Hepatitis C is a blood-borne illness. It may have been contracted from a blood transfusion prior to 1992, contaminated tattoo equipment or IV drug use. Older veterans are particularly at risk due to the use of the old “jet gun” vaccinators by the military and combat injuries, Cave said.

Contaminated dental equipment can also spread hepatitis C, and the disease can be passed from mother to baby.

“The virus can live on a surface for weeks, if not sterilized properly,” Cave said.

Though hepatitis C is now easily curable with proper treatment, the disease can cause major complications if left untreated. It can cause cirrhosis of the liver or liver cancer. Barve, who also directs the Liver Cancer Program at the , said hepatitis C is a leading cause of liver transplant.

Hepatitis C may predispose those infected to diabetes and depression, and it has an association with joint pain, regardless of the amount of liver damage.

The new center will see patients every weekday, and the hospital is expecting 2,000 patient visits per year, with space to expand as volume grows.

A University of Louisville pediatrician’s comprehensive guide to vaccines, known as a standard in the profession, is now available electronically.

The Vaccine Handbook: A Practical Guide for Clinicians – also known as “The Purple Book” for the color of its cover in hard-copy form – has been developed into an app for iOS devices and is available in Apple’s . The guide’s author is Gary S. Marshall, MD, a professor in the at UofL who practices with .

The Vaccine Handbook App contains an updated version of the fifth edition of the book, including the latest immunization schedules and recommendations, Marshall said. The app enhances the print version by including functionality features such as keyword search, internal links, bookmarking, quick access to schedules and tables, hyperlinks to external sources and the ability to make real-time updates.

Published by Professional Communications Inc., The Vaccine Handbook has long been known as an authoritative, user-friendly guide to immunizations. Designed for all health care providers, the guide contains practical advice and background on vaccine program infrastructure, standards and regulations, business aspects of vaccine practice, general recommendations, schedules, special circumstances and how to address the concerns of parents and patients. Specific information about vaccine-preventable diseases, the rationale for vaccine use, and available products also are included.

“We are so excited to make this resource available to any provider who wants it,” Marshall said. “Immunizations are one of our greatest public health triumphs. The more useful and credible information that providers have in hand – which, in the case of an app, it literally is – the more vaccine-preventable diseases will become a distant memory.”

Through a collaboration between the publisher and Sanofi Pasteur, there is no charge to download and use the app, although registration and reporting under the Open Payments act is required.