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St. Elizabeth Healthcare first site chosen for clinical trial for FDA COVID-19 drug, partnering with CTI

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 based in Covington.

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.

“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 successful 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.

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.

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One Comment

  1. It’s very cool indeed and it’s very good that this invention is given to the full-cycle laboratory. Because the results will be as fast as possible. My family and I really hope that soon we will be able to go out again and walk in the park so that my children do not get bored. And then they feel as lethargic as possible, lying on their sides on the couch. Thank you for the article and the information. The reality is that the trials must be successful, huh. I hope so!

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