Virginia Commonwealth University has become one of the first sites in the world to begin clinical trials on a drug to control severe immune overreaction resulting from complications of COVID 19. Charles Fishburne talked with Benjamin Van Tassell, professor in the School of Pharmacy and co-investigator in the clinical trial of canakinumab, which is already approved by the FDA to treat rare auto-inflammatory diseases.
Transcript:
Charles Fishburne: Tell me about the COVID-19 patients that you want to enroll. Who are you looking for?
Benjamin Van Tassell: This study is specifically enrolling patients who had been hospitalized with COVID-19 infection. And they're showing early signs of excessive inflammation. We're trying to capture them. We're trying to enroll them before they go on to a ventilator. So we're trying to stop this process in its early stages.
Fishburne: These patients would come from where, mostly VCU?
Van Tassell: This program is only enrolling patients that are currently hospitalized at VCU.
Fishburne: How many patients do you anticipate in this trial?
Van Tassell: We anticipate about 20 patients locally. At the entire study is going to enroll, I believe, about four or 500 people.
Fishburne: Is this a drug that could save lives? You think?
Van Tassell: Absolutely.
Fishburne: And how do we get from here to getting it in widespread use?
Van Tassell: Right now? It's a drug. It's currently FDA approved. approved for inflammatory disorders similar to arthritis. But these are generally quite rare. In order to have it approved for COVID-19 infection, this study would need to show positive results. And then the FDA would have to review that and decide whether or not they would give it an approval.
Fishburne: How quickly can we do that? I mean, we saw the emergency approval of Remdesivir.
Van Tassell: That's a great question. Everything that we used to know about timelines to approval has kind of got out the window in the last few weeks. So in a normal situation, this is something that would take one to two years, in the best case. If the results are promising, I suspect FDA would move on this quickly. So that by the by the time the study results have been collected and analyzed, you would hope that timeline moves from years to months.
Fishburne: And this drug even if it turns out to be perfect is not a silver bullet?
Van Tassell: Correct. It's really focusing on one aspect of the disease. We don't know that we're going to find a silver bullet that can shut this down at any stages of the process. We know that Remdesivir has been authorized for this emergency or expanded use approval by FDA which will work at some phases of the disease. But once the inflammatory process gets going, there may we may need other tools to treat that. So we're hoping that this can be one of those tools that can focus on the more severe parts of the disease.
Fishburne: Right. At present VCU has three drug clinical drug studies underway. Actually four clinical studies and three drugs.
Van Tassell: You know, it changes every day. We have two of the studies going on. With the Remdesivir, we have another study going on with a slightly different anti- inflammatory approach. This study is up and running would be number four, and there are actually a couple others that are ready to go and maybe starting any day,
Fishburne: Clinical trials always carry a certain amount of risk. What would you say to reassure people who might be involved in this specific trial with this specific drug.
Van Tassell: One of the important things to remember is that every clinical trial before this started is reviewed by an ethics board, that makes... that wants to make sure that we're doing an appropriate job of balancing the risks versus the potential benefits of research. And in this case, we're minimizing the risks of this drug by giving it as just a single treatment. This is... the drug in this treatment is just going to be given as one intravenous infusion. And we think that that should get the patients through the highest risk time period of the infection. This is not a drug that would be continued indefinitely for months and years afterwards. We're just trying to use the minimum amount of drug necessary to intervene at the precise time when the patients with the highest risk
Fishburne: This drug could save a life, you think?
Van Tassell: Absolutely. And I'm convinced that there are similar approaches like this that have been used locally at VCU and across the country. And I'm convinced that we've already seen patients who've had their life saved by this type of approach.
