By Maridith Yahl
NKyTribune reporter
CTI Clinical Trials & Consulting “has had a great relationship with St. Elizabeth since we moved to Northern Kentucky,” Timothy Schroeder, Chief Executive Officer and Founder, told a virtual audience at the Covington Business Council’s “Virtual Luncheon” this week. He was discussing NKY’s Role in Combating COVID-19.
Schroeder was responsible for referring Pulmotect, Inc., a Houston biotechnology company that developed an inhalation vaccine for COVID-19, to St. Elizabeth Hospital for testing.
Tim Schroeder
The partnership between CTI and St. Elizabeth will run two studies that involve between 10 and 20 hospitals around the world. St. Elizabeth was the first hospital worldwide to receive approval. Led by Dr. Chaitanya Mandapakala, MD, pulmonologist and principal researcher, the trial studies the safety of vaccine PUL-042, developed by Pulmotect, and determines if the desired results of the drug are met.
“If this clinical trial is successful it can help heal the disease faster, decrease the length of hospital stay and improve outcomes without needing to get on a ventilator, which is exciting,” Dr. Mandapakala told the audience.
St. Elizabeth is now helping to train some of the other hospitals as they are moving through the steps of the study, says Schroeder.
St. Elizabeth “will obviously be a big contributor to this particular study and we would hope this study will enroll quickly and have positive results. Then [it can] move to Federal trials, possibly as soon as the fall, to be able to try and get this particular drug approved here in the United States and around the world,” says Schroeder.
“We have very quickly become considered one of the experts in doing COVID-19 research,” says Schroeder, having “become global experts.”
Dr. Mandapakala
CTI currently has more than 15 active research studies treating Covid-19 patients. The studies cover a wide range of severity from hospitalized patients, to those on a ventilator with acute respiratory distress syndrome. Providing treatment is what these studies are about. The FDA has allowed a compassionate use program where the Physicians, on a case by case basis, provide specific care.
Schroeder praises his team saying, “Our teams have stepped up to extraordinary measures to the point that we are able to see real-time lives being saved. . .This is an opportunity for me to say how grateful I am for their [his team] willingness to step up and for the outstanding work that they’ve done and for the difference they’re making every day.”
Important advances are being made very quickly in these hospital trials, says Schroeder.
Hospitals like St. Elizabeth are right at the forefront, he says.
CTI has trials running all over the world, including across Europe, Asia, Latin America, and Brazil. With Brazil and Latin America being hit hard by the virus now, CTI is trying to move some studies there to accommodate the vast amount of critically sick patients.
The multitude of studies ranges from treatment, prevention, to preventing deaths of patients on ventilators and even keeping patients off a ventilator entirely to stop lung injury. The side effects of this virus are plentiful. Kidney failure, liver failure, heart issues, blood clotting, and problems in the lungs have been well documented.
“I’m happy to say we have studies that are actually touching all those areas looking at ways to prevent the severity of the disease as well as to diminish the disease so that in fact patients ultimately may not have to go into the intensive care unit or into the hospital itself,” says Schroeder.
Achieving these results would make the virus manageable for individuals and society as a whole.
CTI works with more than 500 hospitals around the world every day, he says.
CTI is aggressively looking for volunteers for studies soon to be moving to the Greater Cincinnati Region. They need more than a billion volunteers worldwide and Schroeder challenges local companies to find 10,000 people to step up over the next three months. Anyone can participate, but each study will have specific qualifications. The studies need healthy individuals, young, old, those with risk factors such as having cancer or transplant and minorities, especially African Americans and Hispanics. To take part in a study call 513-721-3868, text 513-854-3370, or sign up online.
“As a region, we should feel really good about the role our region has played in the pandemic. Great things are happening here in the community. Great progress is being made,” says Schroeder.
