Grace McComsey, MD, University Hospital Clinical Research Center, Cleveland talks about a drug that could alleviate some of COVID’s most debilitating symptoms.
Tell me a little bit about the investigational drug, which I believe is being referred to as Upamostat?
MCCOMSEY: I know, it’s weird. Yeah. So Upamostat. Yeah, it’s an oral drug. It’s very exciting because first we were desperate for any kind of treatment for COVID, right? So, we were so happy with I.V. – intravenous, when people are in the house, they’re sick. Now we’re even asking for more. We want an oral pill. This one is a pill that you take once a day, and it inhibits entry of the virus into the cells as well as the replication. So, the virus is inside, but it doesn’t replicate as much as a typical antiviral effect, as we call it.
So, we really haven’t heard a whole lot about this in the public, have we?
MCCOMSEY: No. It’s one of those repurposed drugs. So, we learned that with COVID, right? When something like that hit, like this pandemic, every company went back and said, wait a second, do I have a drug that has an effect on this virus? So, this was one of those drugs. They went back, they tested it as well as a lot of other drugs against SARS-COV-2, the virus that gives COVID. And what happened is it was extremely effective. So, they did some human studies and looked safe and looks very effective, so now we’re doing the larger study – we call it phase two/three where we’re finding the exact dose. So, we’re giving people one of two different doses. Each dose is given once a day. And as any good study, you have to give it against placebo because you probably heard that 80% or up to 80% of people with COVID will do fine without even going to the hospital. So, if you don’t have a placebo, how are you going to know if they’re just the lucky, you know, 80% or 60% or if the drug did something? So, we’re testing it against a placebo and testing it in two different doses.
That’s interesting. Now, comparing this to Remdesivir. I know you were here for Remdesivir, another repurposed drug?
MCCOMSEY: Exactly. Another repurposed drug that failed in Ebola and then, is now helping people. It didn’t turn out, you know, as great. We were hoping it decreases mortality, but it does help people get out of the hospital faster, and that’s a big deal. So this Upamostat is a drug, I say it’s like Tamiflu where you take it after you get the flu. If you take it the first couple of days, very early after you get the flu, it really helps. It cuts down on the duration of the flu. And we’re all miserable in flu, you know? Like, even if you cut down a day or two, you’re happy usually. So, for this drug, we’re hoping not only that it cuts down on the duration of the symptoms, but it will prevent people from being hospitalized, and that’s the key thing now. Anybody who has COVID, they want to stay home. They don’t want to come to the hospital. So it prevents progression so they don’t end up in the hospital.
So would there be a case that you would use Upamostat as opposed to Remdesivir or is Remdesivir now kind of being pushed aside?
MCCOMSEY: No, I think Remdesivir is still used, but it’s something for when people are sick or hospitalized. They are trying to look for an earlier indication, so people who are still home – the company that makes Remdesivir, I hear, is trying some inhaled form different forms of Remdesivir to try to sell more for early cases. But I would say, you know, it’s not oral. This one, Upamostat is oral, and this is what people love. When they’re sick, they just want to take something once a day, oral, stay home. And this study is like a typical COVID study, I would say. We’re not bringing people into the hospital every day or every couple of days, they’re sick, they don’t they don’t want to come to the hospital. So what we do is the first day we see them, we make sure they screen for the study that everything is good. We give them the drug and we tell them, go home. We give them some neat devices to check their heart rate, their pulse ox, the oxygen in their blood, even their EKG. They’re all like, you know, neat little devices that they can hook by an app through their phone, and it monitors them at home. So, at any point, if they progress, I would know. I’ll get an alert that they progressed. And this is the new way to doing clinical trials, I think. You keep people home at the safety of their home, but you monitor them very well, and that’s what we’re doing.
So, can you explain a little bit about what the drug targets?
MCCOMSEY: The drug has antiviral effect. What it means actually does inhibit entry of the virus into the cells, but also, once the virus is in, it inhibit replication, so it doesn’t replicate and causes more cells to get infected. So, it’s a typical antiviral drug. The nice thing is it has an additional effect that they’ve seen in other studies, not COVID studies. It has been given along with chemotherapy for patients with cancer. It’s not a chemotherapy itself, but along with chemo, it protects some of the tissues from the damage of chemo. So, we’re hoping that, for COVID, it protects the lungs, for example, from having damage because of COVID. And that’s very important because if you take 100 people who have COVID now, the concern is not only if they’re going to end up in the hospital or on a breathing machine or even die from COVID, the concern is what’s going to happen after that. So, there’s something called post-COVID where about 30% of patients will continue to have symptoms past three and six months after COVID. Still unclear why. But for these people, we’re hoping a drug like Upomastat can prevent damages in their organs so hopefully they will have less symptoms down the road. So we’re looking for an effect on the acute illness to prevent hospitalization as well as hopefully on the symptoms post the acute phase.
Excellent. So, who would be the ideal candidate for this drug?
MCCOMSEY: For people to qualify for the study, they have to be COVID positive, but they have to be early in the illness. Like we learned with Tamiflu and flu, you know, typical antiviral effect is seen as soon as possible after the infection. So we want people to be within three days, ideally, of having symptoms, COVID symptoms. We even brought in machines so we can test people on the spot. So, if somebody has symptoms, they come and say, you know, probably COVID, I was exposed to somebody, but I don’t know yet, we can check them on the spot and, if they are COVID positive, enroll them in the study. So, they have to be within three days of symptoms.
That’s a pretty narrow window.
MCCOMSEY: It is narrow. But, you know, if you want to try a drug, I would say you want to try it the right way first. Yes, it makes it a little harder to enroll. You know, instead of enrolling 10 a day, you may be able to enroll one a day. But you want to do it right. We don’t want to end up with no effect while we’re missing an effect if people were early. So, we want to make sure that we know if it works or not.
So why is it a potentially important treatment, especially now?
MCCOMSEY: I think every oral drug or anything you can give at home that’s safe and effective is a big plus in this pandemic, not only for the U.S., for the world. Because if you can give something oral and keep people home so they’re not hospitalized, they’re not dying from it, I think it’s a plus for health care, plus globally for all these hospitals that were overwhelmed with COVID. So, this is the way to do it. Treat early, try to avoid any hospitalization and stay home and hopefully avoid symptoms post-acute phase. That would be ideal.
So, you see great promise for this.
MCCOMSEY: I do see promise. I mean, we’re very excited to get an oral drug. We’ve done a lot of studies with COVID. As you know, we have now 180 studies trying to understand COVID, how to treat it, how to prevent it. But I think this one actually I like a lot because it’s once a day, it’s a pill, it has very good safety record. And for me, most importantly, it’s, like, the way they’re doing the study – it’s so cool to be able to monitor people at home without bringing them here. So we’re hoping that it will be a big success.
Interview conducted by Ivanhoe Broadcast News.
END OF INTERVIEW
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