Many CT scan images of COVID-19 patients’ lungs show patchy, irregular areas where the virus has damaged the lining of the lung. Arizona Republic
St. Elizabeth Healthcare is the first U.S. location to offer a clinical trial of an inhaled drug that scientists hope can limit COVID-19 in patients with early stages of the lung illness.
A separate arm of the trial will study whether the drug can prevent people exposed to the coronavirus from contracting COVID-19 or reduce the disease’s severity if they do fall ill.
“If this clinical trial is successful, it can help heal the disease faster, decrease length of hospital stay and improve outcomes without (a patient) needing to get on a ventilator, which is exciting,” said Dr. Chaitanya Mandapakala, a pulmonologist and principal investigator for the trial of PUL-042 at St. Elizabeth, in a news release.
The goal of the FDA-approved trial, which will be run in up to 20 locations, is to see how effective the drug is and how well patients tolerate it. It wouldn’t be available for broader use until an additional study with more patients.
The drug, developed by Houston-based Pulmotect Inc., is designed to activate the immune defenses of the lung’s mucous membrane and provide broad protection against respiratory infections. PUL-042 triggers a response in minutes to “provide immediate and effective protection against all major classes of pathogens” including bacteria, viruses and fungi “that lasts for days,” according to the company.
The lung damage from COVID-19 is dramatic. Many CT scan images of COVID-19 patients’ lungs show patchy, irregular areas where the virus has damaged the lining of the lung. The patients’ lungs have a patchy appearance with areas of whitish-gray, the so-called “ground glass” appearance unlike other kinds of pneumonia and one that was noted early on as a telltale sign of the disease.
If a patient survives a severe case of COVID-19, “it can take three months to a year or more for a person’s lung function to return to pre-COVID-19 levels,” said Dr. Panagis Galiatsatos, a lung expert at Johns Hopkins Bayview Medical Center in an article posted by the university.
The drug company is running the clinical trial in partnership with Covington-based Clinical Trial and Consulting Services, a global contract research organization.
“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, in a news release.
St. Elizabeth is “the first site to begin screening on this trial because of their ability to quickly execute contracts, develop a site budget, receive IRB (institutional review board) approval, and be trained faster than any other site in the U.S.,” Schroeder said.
The clinical trial is the latest example of St. Elizabeth’s partnership with CTI. Both organizations say they want to expand the relationship to include other diseases, including oncology, immunology, and nephrology, as well as to bring more local attention to clinical trials.
Locations in Oklahoma and Texas also have signed up for the study on easing the damage from COVID-19. But only the St. Elizabeth group is currently enrolling patients in the study, according to the U.S. National Library of Medicine’s website Clinicaltrials.gov.
In the study that includes St. E., 100 patients with early symptoms of COVID-19 will receive the treatment administered via a nebulizer up to three times over six days.
Two hundred patients in the second study will receive up to four doses of PUL-042 or placebo by inhalation over a 10 day period to evaluate the prevention of infection and reduction in the severity of COVID-19.
In both trials, subjects will be followed up for 28 days to assess the effectiveness and tolerability of PUL-042. The study should wind up in October, according to Clinicaltrials.gov.
Patients in both studies will be randomly assigned to either a test group receiving the experimental intervention or a control group receiving a placebo (an inactive substance that looks like the drug or treatment being tested).
Using this technique to compare results from the two groups “suggests whether changes in the test group result from the treatment or occur by chance,” according to the National Institutes of Health website for its aging institute.
Pulmotect is paying for the trials out of its own pocket, with money that came from the final closing of the company’s offering of Series B Preferred stock in March, the company said in a news release.
The Arizona Republic contributed.
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