Norton Healthcare is one of the first in the nation to study convalescent plasma as a therapy to prevent high-risk patients with COVID-19, the disease caused by the coronavirus, from getting seriously ill. Convalescent plasma is taken from blood donated by fully recovered COVID-19 patients. The goal is to determine if the plasma can help prevent these individuals from getting sicker and requiring treatment, including being placed on a ventilator.
“This is exciting because we’re trying to provide an early intervention to prevent progression of COVID-19,” said Joseph M. Flynn, D.O., MPH, FACP, principal investigator for the study and chief administrative officer, Norton Medical Group, and physician-in-chief, Norton Cancer Institute. “This has great implications for long-term care facilities and the many at-risk individuals who remain in a difficult position.”
To be eligible for the clinical trial, hospitalized COVID-19-positive patients must be considered high risk and have markers of inflammation present in their bloodwork. A patient is considered high risk if they are over age 65 or have an underlying medical condition, including cancer, cardiovascular disease, lung issues or high blood pressure. Those who currently use tobacco also may be candidates. To determine effectiveness, researchers will look at changes to respiratory rate, blood oxygen saturation, SARS-CoV-2 antibody levels and changes in bloodwork.
The study is funded with a $50,000 grant from the Norton Healthcare Foundation. It is the first time that Norton Healthcare has been the origin of a Food and Drug Administration-approved, investigator-initiated clinical trial.
“This new trial has been established with the goal of collecting data that will help us determine if this therapy works for this particular population of patients,” Dr. Flynn said.
In the Louisville, Kentucky, area, Norton Healthcare was the first to take part in a clinical trial to evaluate the use of convalescent plasma to help critically ill patients. Over 160 patients have received plasma since April as part of this study. It was part of a larger Mayo Clinic expanded access study that was not developed to examine effectiveness of the plasma, but to help patients and collect data.
That initial trial laid the groundwork for this new trial with data collection in mind. Norton Healthcare developed a robust convalescent plasma donor program, and that has allowed the organization to undertake this new study. The program also is being used by plasma collection centers around the country.
“We had a well-developed process for contacting patients who had recovered from COVID-19; and because of their willingness to donate their plasma, we are able to begin this trial,” Dr. Flynn said. “We continue to work with potential donors, and it is our hope that together we will save many peoples’ lives and prevent critical illness.”
Normally it takes months to get clinical trials opened.
“With the hard work of many, both inside the Norton Healthcare Research Office and outside of it, we were able to open this study in just weeks,” said Stephen Wyatt, DMD, MPH, chief research executive, Norton Healthcare. “In fact, since COVID-19 began to significantly impact our area, we have been able to bring several clinical trials to Louisville with the hope of helping patients and expanding the science-base around treatments that impact COVID-19.”
Norton Healthcare was the first in the world to enroll COVID-19 patients in three clinical trials. These are for the drugs selinexor, APL-9 and acalabrutinib.
The Norton Healthcare Research Office helps to bring new medical advances to our community and to medical professionals and patients throughout the world. During the first quarter of 2020, the research office had more than 1,000 active and pending clinical research studies supporting a full scope of health care services, including 11 pending studies to fight COVID-19.
Norton Healthcare’s clinical trials program is the most robust community health care system-based program in the Louisville and Southern Indiana area, and has been instrumental in the development of many drugs and medical devices. In addition to COVID-19, Norton Healthcare clinical trials include emerging treatments for cancer, cardiovascular issues, neurological conditions, orthopedic conditions, maternal-fetal medicine and more.