In Peoria, clinical trials and a new medicine are bringing hope to the sickest COVID-19 patients – News-Press Now

PEORIA -- Immunology researcher Dr. Joseph Kim switched his focus from organ rejection to COVID-19 in the last few months.

Since coming to Peoria in 2018, Kim had been working with OSF HealthCare Saint Francis Medical Center's organ transplant team to develop better treatments for organ rejection, but COVID-19 has brought him a new challenge.

As an infectious disease specialist, Kim is part of the team treating COVID-19 patients at St. Francis. As part of that work, he is gathering information for a clinical trial on a COVID-19 drug in development by I-Mab Biopharma. St. Francis is one of several hospitals across the country participating in the clinical trial to determine if the drug, currently known as TJ003234, is a safe and effective treatment for COVID-19. The drug is designed to treat the cytokine storm some patients suffer when their immune system overreacts to the virus.

"I'm sure you've heard in the news that some people have a lot of consequences from being sick with the virus: shock, acute respiratory distress, blood clots -- these are different things that happen after infection that may be related to the body's own response against the virus," said Kim. "So what's been shown is that people that have serious infection, their body's own immune response can be very dysregulated, it can be very exaggerated, and that can actually cause harm to the body."

TJ003234 works in a similar way as Tocilizumab, a more widely known drug already FDA approved to treat rheumatoid arthritis. Tocilizumab is also in clinical trials at other hospitals around the U.S. to test its efficacy for the treatment of COVID-19 patients. One of the things researchers are keeping a close eye on is side effects.

"If you are using something that's trying to counteract someone's immune response, some of the unintended consequences could be infection, because you obviously need your immune response to function well to fight off infection," said Kim. "So that's a big concern. So that's why these things need to be studied, obviously."

Clinical trials like this are happening all over the world in the race to come up with an effective treatment for COVID-19. Hospitals are enrolling in trials not only to help researchers, but also to be able to provide some hope for patients and their families for a virus that currently has no known treatments.

"So that's what we've been focusing on at OSF, getting in trials that allow us to give treatments to patients that are very, very sick that wouldn't be available otherwise," said Kim.

The trial, which began in mid-April, is in an early stage, where just a few patients have been given the drug to make sure it is safe, said Kim. Once safety is determined, it will be administered to more patients, and results will be recorded to determine if it is helping. Since it is a double-blind trial, with one group getting the drug and another getting a placebo, Kim and other researchers won't know the results until all the data is gathered.

The clinical trial is one of two COVID-19 trials being done at St. Francis. It is also participating in a clinical trial headed by Mayo Clinic on convalescent plasma, anti-body rich blood plasma gathered from recovered COVID-19 patients.

"Your body makes antibodies, and those antibodies can be protective against that virus," said Kim. "So basically what you are trying to do is taking the antibodies that are protective and give them to someone who doesn't have them yet, someone whose body is not making effective antibodies."

The convalescent plasma study is not a blind study, and last month researchers announced that a couple patients who had received the plasma were recovering. But as yet, those happy results are only anecdotal -- researchers are not yet ready to say if convalescent plasma is truly helpful in the treatment of COVID-19.

"With all these studies, you can't draw firm conclusions with such a small sample size and one physician's experience with a patient," said Kim. "That's the problem, and that's what's so hard about being able to treat patients and navigate through this pandemic -- we don't have this type of data yet. For other infections, like influenza, we have different treatments and vaccines. Influenza has definitely been studied well, so we can be confident about the effectiveness of what we are doing. It's just unfortunate that it's just not like that for COVID-19."

Another treatment doctors at St. Francis are using is Remdesevir. Because it has already been studied and has shown enough promise that the FDA gave it emergency-use approval, hospitals don't have to enroll in a clinical trial to get the drug.

"We've used it in Peoria on three patients so far," said infectious disease specialist Dr. Douglas Kasper, a faculty member at the University of Illinois College of Medicine Peoria. "Remdesevir can be used as an antiviral agent, with the idea that you are arresting viral replication as early as possible."

Though it has shown some promise in one study, doctors are still evaluating its worth as a treatment, said Kasper. Another issue with Remdesevir is that it is in very short supply. Area hospitals have only been given enough to treat a few patients.

All research is contingent on need, and no one knows what the need will be for COVID-19 treatments going forward.

"To do a clinical trial, you have to have sick people, otherwise you don't have anyone to enroll in the trial," said Kasper. "As the summer goes, and if our rates continue to go down, we won't make progress because we won't have anyone to enroll. That is kind of what happened with the first SARS virus. It was circulating mostly in Asia, causing terrible effects, and there was a huge response into the development of therapeutics and a vaccine. Towards the end of that outbreak, the virus mutated and became weaker, and clinical effects on people were less -- people didn't go to hospital and didn't die, then drive from industry became less. Could that happen with COVID-19? It could, but it's not something you could bet on. We don't know. That's the part of this that is so interesting -- each day, every week, it changes so much. To be able to match all this up and plan is quite a process."

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