Q&A: LSU Dean Talks Drug Trials For COVID-19 Treatment

Pharmaceutical company Amneal donated 400,000 doses of hydroxychloroquine to the State of Louisiana this week.

It’s a drug typically used to treat malaria, but there is hope among some scientists and doctors that it could be used to treat patients with COVID-19.

The Louisiana State University School of Medicine will use some of those pills in a clinical trial to further study the drug. We spoke about the study with Dr. Steve Nelson, dean of LSU’s School of Medicine in New Orleans.

Travis Lux: I want to start by talking about what this drug is. It’s currently used to treat malaria, so what makes scientists and doctors think that hydroxychloroquine can be helpful for treating COVID-19?

Dr. Steve Nelson: Chloroquine, which is the parent compound of hydroxychloroquine, has been available since, I think, the 1940s. As you stated, it was used for the treatment of malaria.

But like many different drugs, as it was investigated, it was found to have other properties. And one of the properties it was found to have was antiviral properties. In a test tube or petri dish, it’s been shown to have activity in terms of killing the virus and preventing it from replicating. So that’s one piece of evidence.

The question is, in humans, could it work in terms of an actual patient — to decrease the viruses in that person. There’s been anecdotal evidence of this in small trials, not controlled very well. And so there’s lots of reports this may be helpful, but nothing proven.

The other thing about this drug is that it’s really a fairly safe drug. So the risk-benefit ratio is low. In other words, the risk of giving it to a patient, except if you have certain heart conditions, is really very low. So I think that’s why people are so enamored with it. There’s enough scientific evidence to suggest that it might be helpful, so let’s keep our fingers crossed.

The state of Louisiana got this big donation of this drug from pharmaceutical company Amneal. LSU’s School of Medicine is going to be doing clinical trials to figure out whether it works. Can you explain how the trials are going to work? When does it start, how long is it going to take, and who will get the drugs?

In terms of when the trials will start — the thing that we were waiting for was the drug, hydroxychloroquine. Because as these early reports came out that this drug may have a benefit for this disease, people started getting them. So it was almost impossible to get them in the local pharmacies, much less any place else.

So, now that we have the drug, the protocols are just about completed. We’re waiting final approval, so we hope for those studies to start at the end of this week, or next week at the latest.

There are going to be two trials. One is a prevention trial. As you can imagine, the doctors, the nurses who are in the ER and the ICU dealing with these very ill people are the ones that are really in the line of fire. So the idea here is that if you give a certain amount of this drug prophylactically — before you get exposed — can you prevent those individuals from getting the disease? So that’s a prevention trial.

The other trial will test whether or not this drug can improve the course of this illness. These would be people who come into the hospital. They’re admitted, either on the floor — so they’re not that sick, maybe they need some oxygen but not a lot — or they’re really ill and wind up in the ICU and end up on a ventilator. Those are basically the two trials.

When are you expecting this study to be finished up, and we’ll have some data to work with?

There will be three arms to this study. Some patients will just get conventional treatment. Some patients will get hydroxychloroquine, and another group of patients will get hydroxychloroquine and another antibiotic called azithromycin (which is commonly known by most people as a Z-pak).

The idea is there will be roughly 200 patients in each of those three arms. So it’ll be about 600 patients. But as you know, we have large numbers of patients, unfortunately. So I don’t think it will take very long for this study to be completed. I think probably within a month.

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