St. Elizabeth Healthcare has been selected as the first site of the FDA-approved Phase-2 COVID-19 clinical trial studying the drug PUL-042 of Pulmotect, Inc., in partnership with CTI – Clinical Trial and Consulting Services (CTI), a global full-service contract research organization. The clinical trial will study the safety and efficacy of PUL-042, Pulmotect’s inhalation solution, for the prevention of disease progression in patients with early COVID-19 disease. U.S. Food & Drug Administration (FDA) approval occurred last week and the trial is active and will be conducted at up to 10 clinical sites throughout the country, starting with St. Elizabeth in Northern Kentucky, the first hospital site in the world to be able to start dosing patients.
St. Elizabeth Healthcare in Edgewood, Kentucky becomes first hospital site in new clinical trial targeting COVID 19 in partnership with CTI and Pulmotect.
“The drug PUL-042 boosts the innate immunity in the lungs and potentially prevents further lung damage when used early in the COVID-19 disease,” says Chaitanya Mandapakala, MD, pulmonologist and principal investigator, for the Pulmotect clinical trial at St. Elizabeth. “If this clinical trial is sucessful it can help heal the disease faster, decrease length of hospital stay and improve outcomes without needing to get on a ventilator, which is exciting.”
This clinical trial represents the latest example of St. Elizabeth Healthcare’s strategic partnership with CTI. Both organizations look forward to rapidly expanding this relationship to include other diseases, including oncology, immunology, and nephrology, given the high-quality facilities, as well as the dedicated medical and research teams at St. Elizabeth, which is located close to CTI’s headquarters. They hope to bring more local attention to clinical trials and the importance of research.
“The COVID-19 pandemic demands an unprecedented response from the pharmaceutical and biotechnology communities, requiring innovation, collaboration, and prioritization of speed without the cost of safety,” said Tim Schroeder, Founder and CEO of CTI. “We are proud to have the opportunity to collaborate on such a response with the St. Elizabeth team and to work together to develop an effective treatment solution for those hardest hit by COVID-19. The leadership from CEO, Garren Colvin, and his executive team has been outstanding in every aspect. They are the first site to begin screening on this trial because of their ability to quickly execute contracts, develop a site budget, receive IRB approval, and be trained faster than any other site in the US.”
CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, and Asia-Pacific.
About St. Elizabeth Healthcare
St. Elizabeth Healthcare operates five facilities throughout Northern Kentucky and more than 115 primary care and specialty office locations in Kentucky, Indiana and Ohio. A member of the Mayo Clinic Care Network, St. Elizabeth is a mission-based organization committed to improving the health of the communities it serves, providing more than $116 million in uncompensated care and benefit to the community in 2018.