BIRMINGHAM – A topic of discussion during Coronavirus Task Force briefings at the White House during the COVID-19 pandemic has been the use of hydroxychloroquine and clinical trials.
President Donald Trump discussed hydroxychloroquine on Monday, saying “just recently a friend of mine told me he got better because of the use of that drug.”
“Over the last seven days, my administration has deployed roughly 28 million doses of hydroxychloroquine from our national stockpile,” Trump said during a Coronavirus Task Force briefing on April 13. “We have millions of doses that we bought and many people are using it all over the country.”
Dr. Beth Lewis, MD, MSPH, FACP, FAHA, Department of Medicine and Division of Preventive Medicine at the University of Alabama at Birmingham (UAB) discussed the use of drugs such as hydroxychloroquine amid the coronavirus pandemic.
Lewis said she “certainly” would be open to being in a clinical trial to see the effects of hydroxychloroquine in relation to COVID-19.
Lewis mentioned that she has taken part in clinical trials for a living.
“If I was so unlucky to get COVID-19 and to be hospitalized, I would tell them to put me into a clinical trial,” Lewis told Vols Wire. “I have been involved in a number of different clinical trials, not in anti-virals, but in other things. I believe that is the best data that you are going to get for whether an intervention is actually going to do more good than harm.”
Lewis also discussed how long she thinks a clinical trial for the coronavirus could take.
“There are some new adaptive designs that can go pretty speedily,” she said. “With a large outbreak, you should be able to accrue several hundred patients fairly promptly, so we should be getting information out of trials this summer. With the adaptive designs, they are periodically analyzing the data and once it becomes clear if a medication looks like it works and has an acceptable safety profile then they can change the design so that it becomes more than what the design started to be.
“Typically you do not know if anything works at all, you have a group that gets a standard of care that you are trying to do and a group that gets a standard of care plus a new medication. With an adaptive design, once you have the evidence that a new medication works, then you can change the design so that it is standard or the control group gets that new medication. Then you can compare other medications to that to see if something works better or you can try combination therapies. You can get things to really move along now with some of these designs and the way that we can do clinical trials.”
With hydroxychloroquine being discussed during the coronavirus pandemic in reference to clinical trials in treating COVID-19, Lewis discussed the process of testing such drug in order to find a cure.
“At the beginning you are sort of testing a new vaccine to see if it is safe and if it causes any side effects to people,” Lewis said. “Then once you get something that looks like it is safe then you can see if it works in larger number of people.
“That is where the money is going to be in. Once we get medications that work, especially when we get a vaccine, then we are in business.”