St. Elizabeth Selected as First Testing Site for Phase 2 Trial of COVID-19 Drug
St. Elizabeth Healthcare will serve as the first site for a newly approved phase-two clinical trial studying the effects of the drug PUL-042, created by Pulmotect, Inc. in partnership with Covington-based CTI Clinicial Trial and Consulting Services.
The second phase of the trials was approved the federal Food & Drug Administration.
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.
FDA approval occurred last week and the trial is active and will be conducted at up to ten 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.
“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," said 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."