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Tri-State hospital selected as clinical trial site for ‘exciting’ COVID-19 treatment

Written by Brian Planalp

EDGEWOOD, Ky. (FOX19) - St. Elizabeth Hospital has been selected as the first test site of for a phase-2 clinical trial studying a drug to treat COVID-19.

The drug, Pulmotect, or PUL-042, aims to prevent COVID-19 from progressing in patients infected with the novel coronavirus, according to a St. Elizabeth spokesperson.

The drug was approved by the FDA last week.

According to the spokesperson, the clinical trial will be conducted at 10 sites throughout the country, beginning with St. Elizabeth, making the Northern Kentucky hospital the first in the world to start dosing patients with the virus.

Chaitanya Mandapakala, MD, pulmonologist at St. Elizabeth, is the clinical trial’s principal investigator.

“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," Mandapakala explained.

“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.”

Phase-2 of the trial will study the safety and efficacy of Pulmotect, according to the hospital spokesperson.

St. Elizabeth is partnering on the trial with Clinical Trial and Consulting Services, a global contract research organization based in Cincinnati.

“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,” Founder and CEO of CTI 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 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.”