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UC Hospitals Begin Recruiting For Coronavirus Drug Trials

 March 27, 2020 at 12:36 PM PDT

Speaker 1: 00:00 Today. We know that a third person has died from coven 19 and San Diego County. The latest death was an 87 year old woman who was in an assisted living home in Rancho San Diego. All of the people who have died from the disease locally were in their seventies and eighties at last, counted a total of 341 people in San Diego County have tested positive for the disease that's twice as many as we saw on Sunday that gay PBS newsroom is hard at work. Examining the many effects of the Corona virus, be they economic, social or medical. San Diego is the center of a large life science community and scientists are working to find a possible vaccine to prevent infection and so-called antiviral drugs to treat the people who have it. Joining me is KPBS Sai tech reporters, Shalina, Chad, Leilani and welcome. Shelina. Speaker 2: 00:51 Hey, glad to be here. Speaker 1: 00:52 Let's start by talking about a possible treatment for those who have gotten sick. What do we know about REM Deza here and has it work? Speaker 2: 01:00 So REM does severe as an antiviral drug that's going through clinical trial right now. At UC San Diego and another, a number of other UC schools for a potential treatment for coronavirus. This drug works by targeting a type of enzyme or protein used in the body by many viruses to copy itself and therefore spread throughout the body. So instead of targeting the virus itself, this antiviral works by stopping a virus from multiplying. It doesn't specifically target coven 19 but a report from the magazine science says it's had some promising results in studies around other viruses that had similar respiratory conditions. Speaker 1: 01:40 Now maybe some of his, I had been spending a little more time thinking about vaccines, but this is a treatment, antiviral drugs, treat it once he got it. Speaker 2: 01:49 Yeah. So there's a difference between a vaccine and an antiviral drug. So a vaccine is something that you get to prevent yourself from getting infected with something. By allowing the human body to create an immune system response to whatever it is that's invading the body at the time. Think about those flu shots that, uh, healthcare officials are constantly nagging us to get every single year. It's to make your immune system responsive to the flu. An antiviral drug, on the other hand, is something that treats a disease by preventing a virus from replicating or spreading, essentially killing the virus. So both of these things are critical in a longterm solution to meeting or a virus because obviously you want to prevent people from getting into the first place, but then you also want to treat people who have it. Speaker 1: 02:34 You know, we were talking about clinical trials for REM Dez Avir. Is UC San Diego involved in that? Speaker 2: 02:40 Yes. So UC San Diego health and other UC health centers are involved in this. And in the past, the drug has been studied in human clinical trials of Ebola, uh, but it was found to not be very effective against the infection. And it's been tested in a number of people with other types of viruses that, uh, have the respiratory types of conditions. And it has been used in an emergency expanded programs for Ebola. So some of the adverse effects that we do know, again, this is a very limited study within humans, is that it could lead to things like headache, nausea, elevation of liver tests. When you have these clinical trials, they come in several phases and you have to recruit people. Now who is being recruited for the second phase of the clinical clinical trial for REM, Dez Avir and how big or finite a group is it that's going to be tested? Speaker 2: 03:32 Yeah, so first and background, because I didn't mention this in my last answer for some background in clinical trials, usually the way they go is that you start off testing in animal models to see if a whatever therapy that you're working on could potentially be safe to be used in humans. And then you go to a neck next phase of the trial, which is human clinical trials. And so that kind of gives you a better idea of where this particular antiviral drug is in terms of how it's been tested because it's already been tested in human clinical trials for a Ebola. So there will be 440 participants chosen. It's based on eligibility criteria. They have to have been tested positive for coronavirus and have serious symptoms. Exclusion criteria are based on safety. Since there's been a limited number of trials with humans, people that have elevated liver tests and reduced kidney function, pregnant women for example, will not be able to enroll and we need a 440 participants. Speaker 2: 04:26 I guess we already have a 300 some people who have tested positive for the Corona virus. So we're on our way. Certainly this study is supposed to last through April, 2023 so this is just the beginning of a long process, right? It is the beginning of a long process and and good that you brought up the fact that we already have close to that many people who have tested for coronavirus in San Diego. I mean, again, this is across a number of UC schools. And so when I did send an email to the principal investigators about how long this would be taking, they even said, you know, I imagine it's not going to take that long to enroll potential participants in this trial because across California, there are many, many more people who tested positive for Corona virus. So they say that, you know, three to four weeks from now, they should probably be able to have the number of people they need necessary to get this trial started. Speaker 2: 05:19 So it does say that it's supposed to last till April, 2023. But that being said, be know things are moving a lot more quickly now when it comes to clinical trials around finding treatments for Corona virus. So the researchers say the timeline potentially could be a bit more flexible depending on whether they start seeing some safe results coming up more quickly. Now you say this could take a little less time than three years, but, uh, I gotta tell you the idea that we won't know the drug's effectiveness possibly until 2023 may raise some eyebrows. People are probably wondering, well, do we have anything now, Speaker 1: 05:57 now that we're in this crisis? And what do you say to that? Are there any antiviral medications available today that can do anything to treat Kovac 19 Speaker 2: 06:06 yeah, so when it comes to the timeline, um, in that regard, you know, clinical trials and safety around how long drugs, you know, I need to be tested takes a long time at this particular moment. A lot of these studies are sort of being fast track so that we can get something. So 2023 might seem like a long time from now, from now. But in the scientific community it's probably just a, you know, it might be a little bit faster or along what's normally supposed to happen. Now when it comes to the question of, okay, are there anything, are there any treatments available right now? Obviously that's a very pressing concern to be able to treat people who have the virus. The short answer is no, there's nothing that has been deemed completely safe and uh, should be used by patients who have coronavirus or to prevent Corona virus by organizations like the NIH or the CDC. Now that being said, uh, there are a number of different drugs that are being tested right now to treat as a potential treatment for Corona virus. So this is not the only solution that people are looking towards. Okay. But, uh, so far, no cigar Speaker 1: 07:18 as they say. What are some of the challenges associated with conducting these trials in the middle of a Speaker 2: 07:24 pandemic? There are some obvious logistical issues. For example, people are supposed to be practicing social distancing and so that obviously presents some challenges when it comes to, for example, bringing patients into a treatment center and having them interact, interact with a staff. There are local rules that may govern travel or depending on who should come in or patients might get sick during the clinical trial. And obviously trial staff have to be able to protect themselves. You know, these are some obvious logistical challenges, uh, that are around this trial right now. I'm in a pen demic that, you know, wouldn't necessarily otherwise exist. Speaker 1: 08:03 Well, I've been speaking with KPBS science and technology reporter Shalina Celani and thank you very much. Speaker 3: 08:12 Uh.

Researchers at four University of California Health medical centers — including UC San Diego Health — have begun recruiting participants for a clinical trial to investigate the safety and efficacy of treating adult COVID-19 patients with an antiviral drug that has shown some success against other viruses.
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