You may have heard Dr. Anthony Fauci yesterday talking about promising results from a clinical trial using a drug called remdesivir to treat COVID-19. What is Remdesivir, what does this result mean, and what does Birmingham’s own UAB have to do with it? Find out what we learned from the experts.
“The data shows that remdesivir has a clear-cut, significant and positive effect on diminishing the time to recovery.”Dr. Anthony S. Fauci
For those of us who aren’t doctors or researchers, we went to the experts at UAB to find out what all of this means, and how Birmingham, Alabama, is turning out to play an important role in the race against COVID-19.
But first, some basic facts about UAB’s role
On March 25, 2020, just over one month ago, UAB was activated as one of many sites for a phase three clinical trial by the National Institute of Allergy and Infectious Diseases (NIAID) as part of the National Institutes for Health. This international study, initially intended for 400 participants, ended up enrolling over 1000 participants around the world.
Here’s what Dr. Paul Goepfert, the principal investigator on the trial, said at the time, according to UAB:
“Remdesivir worked well in the test tube and animal models against a close relative of COVID-19. We are very excited to have the opportunity to rapidly determine whether this drug will help treat hospitalized patients with COVID-19 here at UAB.”
Just one month later, the results are in, and the news seems hopeful.
Meet the UAB doctors in charge of the trial + find out UAB’s role in the development of the drug
Two doctors from UAB’s Division of Infectious Diseases played a leading role in the Remdesivir clinical trial for COVID-19. Paul Goepfert, M.D. (above left) was the principal investigator, while Nathan Erdmann, M.D. (above right) oversaw the enrollment of patients.
UAB’s Dr. Richard Whitley played a key role in the development ofrRemdesivir—initially to be used for Ebola. Unfortunately, it didn’t work very well for Ebola, but has shown some promising results against SARS, MERS, and now SARS-COv-2, the virus that causes COVID-19.
UAB collaborated with Southern Research Institute and a number of other institutions to conduct a study with the drug in Wuhan, China, where the Novel Coronavirus outbreak originated.
The results, in a nutshell
At the outset of the trial, researchers were hoping for 400 patients and results by mid-May. Because of the scale of the pandemic, they were easily able to enroll 1063 patients at all sites.
By Monday of this week, they had initial data from around 400 patients, showing that hospitalization stays were able to decrease from 15 days to 11 days, with fewer side effects from the illness.
According to Goepfert, they “anticipate having more robust data over the next weeks in terms of what’s the therapeutic benefit of the drug from this study.”
Whether or not it’s a game-changer is to be determined, but the doctors feel confident that Remdesivir will help patients and means that “we have at least one drug available that can improve overall outcomes.”
Goepfert went on to explain that “this is an important first step, because remdesivir is the first drug tested in humans with direct anti-virus activity, and it worked. . .an effectiveness rate of 31% over the placebo doesn’t sound fantastic, but it’s likely to be saving lives.”
The implications of this could be significant, for example shorter hospital stays and less need for ventilators, for starters.
More importantly, as Fauci explained in his press conference yesterday, researchers are hopeful that today’s finding will prove to be similar to the initial clinical trials of the antiviral AZT which proved critical in the fight against HIV/AIDS.
No, AZT wasn’t wildly successful on its own, but, as Goepfert explained “it ushered on the advent of many other anti-viral drugs that worked incredibly well for HIV.”
A hard month with hope at the end of it
April 2020 will no doubt go down as one of the hardest months for many people and organizations in recent memory, and now that it’s almost over, there’s a glimmer of hope on the coronavirus front.
Here’s what Goepfert had to say about that:
“It’s pretty incredible. I’ve done a lot of trials for a long time and I don’t think I’ve ever gotten a positive result so quickly. This will likely become Standard of Care.
The challenge is gonna be for Gilead, the drug maker, to come up with enough doses, to treat the number of people that are gonna need this. I suspect that soon doctors are gonna want this drug to treat everybody who gets hospitalized with a severe infection.
This is an exciting time—not a home run at this point, but extremely hopeful. At least now we have something that can make a change in someone’s life who has severe coronavirus infection.”
Erdmann added: “It’s not a miracle drug . . .but to have actual positive progress this quickly in the global outbreak is certainly encouraging.”
The next phase of this current study includes testing an anti-inflammatory agent that can help suppress an overactive immune system to help a patient deal with infection better.
Next steps in the overall process include analyzing data from the study more fully, peer review and potential fast-track for FDA approval of the drug (or at least an expansion of its current compassionate care use).
We’ll keep watching what the researchers at UAB are doing to as scientists’ understanding of SARS-COv-2 and COVID-19 evolves.