Regional One Health and University of Tennessee Health Science Center are taking part in trials for a therapy aimed at preventing coronavirus symptoms from getting worse.
The treatment will also be tested on close contacts of coronavirus patients to see if it can prevent illness.
Participants will receive a one-time IV infusion of the treatment, and then will be monitored at home to see if their symptoms improve.
As COVID-19 continues to impact daily life, the question on everyone’s mind is how to return to some version of normal.
Regional One Health and the University of Tennessee Health Science Center are helping answer that question by participating in clinical trials of a treatment that aims to stop coronavirus symptoms from worsening. Ultimately, researchers hope the therapy could also prevent illness in people who have been exposed.
Leading the way are John Jefferies, MD, MPH, professor and chief of the Division of Adult Cardiovascular Diseases at UTHSC, and Amber Thacker, MD, medical director of the Hospital Medicine Service at Regional One Health, who will work with patients at Regional One Health’s downtown campus, the only Tennessee site for the trial.
The potential implications are enormous. “If this works, it’s potentially transformative,” Dr. Jefferies said. “We don’t foresee an end to the pandemic anytime soon, so the question becomes, ‘How do we deal with it?’ This provides us with an opportunity to decrease morbidity and mortality, and with the second study prevent household contacts from contracting the virus in a home with someone who is COVID positive.”
“Memphis is a hard-hit area,” Dr. Thacker added. “Many of our patients have comorbidities that put them at higher risk, so we see patients who are very sick. Treating people before they need to be in the hospital, or giving them better outcomes if they are hospitalized, is an amazing thing.”
Martin Croce, MD, chief medical officer at Regional One Health, said, “Those individuals in our community suffering with COVID-19 symptoms will have the opportunity to participate in and possibly benefit from this trial, but the implications will be far reaching. It’s exciting to be able to offer this in our community and to know what we are doing here at Regional One Health, along with the UTHSC College of Medicine, has the potential to positively impact the treatment of COVID-19 patients everywhere moving forward.”
There have already been initial trials on the efficacy and safety of the treatment, which is being developed by Regeneron Pharmaceuticals. “All of the data suggests this treatment is safe and effective, even covering some of the variants that are developing with the virus,” Dr. Jefferies said. “It doesn’t cause damage to existing normal human tissue. It only targets the virus.”
Patients will receive a one-time IV infusion of the therapy. After that, they’ll be monitored at home to see if their symptoms improve.
Researchers are now seeking further confirmation and specifics about dosage.
At Regional One Health, patients with COVID-19 symptoms, who test positive and meet study criteria, can be referred to Dr. Thacker or another member of her hospitalist team within 96 hours of their positive test. Individuals who think they may qualify are encouraged to contact 901-448-2499 for more information.
Individuals may also learn more about the criteria and enroll at www.ClinLife.com/COVID.
To participate in the treatment trial individuals must be at least 18 years old, have a laboratory confirmed COVID-positive diagnosis or experience COVID symptoms, and have not been hospitalized due to COVID-19. To participate in the prevention trial, participants must be at least 18 years old, test negative for COVID-19, and live and remain in the same household with someone who recently tested positive.
Participants will receive a one-time IV infusion of the medication. The infusion takes about an hour, and patients are monitored onsite for several hours.
Then, patients can go home, where they have follow-up visits from a home health provider for lab work and assessment. Dr. Jefferies noted that not only makes it easier on the patient, it keeps them from having to leave the home and potentially expose others to COVID-19.
The hope is that patients will see their symptoms stabilize and improve, resulting in fewer hospital and ICU admissions. “Hopefully, we can prevent people from getting sicker and being admitted to the hospital,” Dr. Jefferies said. “If you are admitted to the hospital, that incurs a certain amount of mortality. If you progress to the ICU or to being intubated, your likelihood of survival goes down.”
If the treatment proves effective in helping sick patients get better, researchers will also test it in close contacts of COVID-19 positive patients who are not yet ill. “We’ll see if it prevents the infection in people who have been exposed,” Dr. Thacker said. “If we can prevent patients from ever having symptoms, that, along with a vaccine, can change the game.”
Home health workers will visit participants to get lab work and monitor their symptoms during the study.
The treatment works by using a pair of monoclonal antibodies that act on the “spikes” on the outside of the coronavirus to prevent them from attaching to cells in the human body. If the virus can’t attach to cells, it can’t attack the host.
“The spike on the virus is like a key in a door. It lets the virus complex basically get swallowed into the cell, and once it gets to the cell it starts replicating,” Dr. Jefferies said.
The treatment is similar to using plasma from recovered patients. However, there are advantages to using synthetic antibodies.
“The human body makes antibodies that respond to different parts of the virus, and you need the donor to have a high level of antibodies,” Dr. Thacker said. “These antibodies are generated in a lab, so it’s more targeted. They were chosen because they have been shown to be effective.”
Also, Dr. Jefferies noted, plasma treatment is harder to produce in mass quantities – the volume is inherently lower, and it’s dependent on donors. “Because this is something we can produce, I would anticipate the ability to scale would ultimately be able to meet the expanding need,” he said.
For now, it all depends on the results of the trial.
Dr. Jefferies said researchers will review data throughout the study to determine if the treatment is working. “The goal is to get an FDA approval so this can be prescribed,” he said. “Everyone is eager to find something that works, so the FDA will be looking for data that compels them to deem this safe and allow people to have access.”
He is excited that Regional One Health will be part of working toward that outcome.
“It’s a big deal,” Dr. Jefferies said. “It shows that we have a unique team that can perform and do this study with a population that’s at risk. The fact that they chose Regional One Health shows a level of confidence in what we have to offer in terms of personnel and resources.”