Being conducted in alliance with Clinical Trial and Consulting Services (CTI ), the trial will assess the safety and efficacy of PUL-042 in preventing disease progression in patients having early Covid-19.
The trial, which secured the US Food and Drug Administration (FDA) approval, will be performed at up to ten sites across the US, beginning with St. Elizabeth in Northern Kentucky.
St. Elizabeth is said to be the first hospital site to commence patient dosing.
St. Elizabeth Healthcare the Pulmotect clinical trial principal investigator Chaitanya Mandapakala said: “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.
“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.”
St. Elizabeth and CTI intend to expand their partnership to include other diseases, including oncology, immunology and nephrology indications.
CTI founder and CEO Tim Schroeder said: “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 CovidD-19.
“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.”
In addition to five facilities in Northern Kentucky, St. Elizabeth runs more than 115 primary care and specialty office locations across Kentucky, Indiana and Ohio. It is a member of the Mayo Clinic Care Network.