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St. Elizabeth Ft. Thomas will be first hospital worldwide hosting clinical trial for new COVID-19 drug

PUL-042 boosts immunity in the lungs
Posted at 9:48 PM, May 18, 2020
and last updated 2020-05-19 10:14:20-04

FORT THOMAS, Ky.  — A local hospital is leading the way in a promising new study designed to treat COVID-19. St. Elizabeth Healthcare is the first hospital in the world, and one of only 10 sites throughout the United States, selected to conduct a clinical trial to study the safety and efficacy of the new drug PUL-042.

The goal of the study is two-fold: a medication that helps the body manage COVID-19 symptoms on its own and a way to eventually treat the disease outside of a hospital.

“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 Dr. Chaitanya Mandapakala, 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."

Mandapakala said the medication his team is testing is designed to keep COVID symptoms from advancing and our healthcare system from getting overwhelmed.

“When COVID gets worse, you go on to oxygen,” he said. “From oxygen you get onto a ventilator. And that’s how hospitals start running out of ventilators.”

The doses being tested at the Fort Thomas site are in the form of a nasal spray. Other potential treatments are given intravenously, require multiple doses and can’t be administered at home, which Mandapakala said is a key aspect.

“If you want a medication that prevents people from getting sick,” he said, "you want a medication that can be given even outside the hospital.”

PUL-042 works on receptors in the lungs to boost immunity so the patient’s body fights the disease better. Once the lungs start to fail, the entire body’s work gets harder.

“The hope is if you can prevent damage initially, then you are protecting a lot more of your body and health in the future as well,” Mandapakala said.

The trial is scheduled to last three or four months before it sees another phase and there is no timetable for when it could be approved for mass production.

“I really hope what we do helps the community in the big picture,” Mandapakala said.

PUL-042 was approved by the U.S. Food & Drug Administration (FDA) on May 5.

The trial came as a result of St. Elizabeth Healthcare’s association with CTI Clinical Trial and Consulting Services, a global contract research organization.