COVID-19 is a disease whose fatal symptom is typically an attack on the lungs, ground zero for the disease that has killed tens of thousands of Americans in just a few months.
The deadliness of the disease has stepped up the urgency of developing drugs to treat the breathing problems caused by the virus. Northern Kentucky’s largest health system, St. Elizabeth Healthcare, has been selected as a site of a clinical trial to study a drug that could fight off the infection in the lungs.
The drug is called PUL-042 and was developed to treat breathing problems in cancer patients by Pulmotect, Inc., a Houston-based biotech company.
The trial to see if it is safe and effective to treat COVID-19 patients is being partly overseen by Covington-based CTI Clinical Trial and Consulting Services, a contract research firm.
“The drug 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, a pulmonologist and the principal investigator for the trial at St. Elizabeth.
If the trial is ultimately successful, the drug could “help heal the disease faster, decrease length of hospital stay and improve outcomes without needing to get on a ventilator, " Mandapakala says.
The U.S. Food & Drug Administration approved the Phase 2 trial in early May and it will be conducted at up to 10 sites throughout the country, starting with St. Elizabeth, which officials say will be the first hospital site in the world to be able to start dosing patients.
The drug is designed to harness the power of the body’s immune system to fight off a range of respiratory infections. It was initially targeted to treat respiratory complications of cancer patient treatment, Pulmotect says. When COVID-19 became a widespread threat earlier this year, the company shifted its focus to test its effectiveness in fighting the emerging disease.
In the study, up to four doses of the experimental drug or a placebo will be given to 200 patients by inhalation over ten days to see whether it prevents further infection and reduces the severity of the disease, Pulmotect says. Patients will then be followed up for 28 days to gauge how effective the drug has been and how they tolerate it.
Continued COVID-19 coverage has been supported by a grant from the Facebook Journalism Project, a program run in partnership with the Lenfest Institute for Journalism and Local Media Association.