|UAB Medical Center|
An antiviral drug that began development at UAB in 2014 is showing promise as a treatment for COVID-19 patients, according to multiple news reports last week. The positive results for the drug remdesivir, so far, are based on anecdotal evidence, but the drug maker, California-based Gilead Sciences, is expected to produce detailed data by the end of April. Could Alabama scientists play a prominent role in resolving one of the most severe public-health threats of the modern era? Early results from clinical trials indicate the answer is yes.
Dr. Richard Whitley, UAB distinguished professor of pediatrics, is the principal investigator on a $37.5-million grant from the National Institute of Allergy and Infectious Diseases (NIAID). The grant funds UAB's Antiviral Drug Discovery and Development Center (AD3C), where much of the research on remdesivir has been conducted, involving scientists from multiple institutions.
The first report that remdesivir was showing promise in at least one clinical trial against COVID-19 came from a report dated 4/16/20 at statnews.com:
A Chicago hospital treating severe COVID-19 patients with Gilead Sciences’ antiviral medicine remdesivir in a closely watched clinical trial is seeing rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged in less than a week, STAT has learned.
Remdesivir was one of the first medicines identified as having the potential to impact SARS-CoV-2, the novel coronavirus that causes COVID-19, in lab tests. The entire world has been waiting for results from Gilead’s clinical trials, and positive results would likely lead to fast approvals by the Food and Drug Administration and other regulatory agencies. If safe and effective, it could become the first approved treatment against the disease.
The University of Chicago Medicine recruited 125 people with Covid-19 into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe disease. All the patients have been treated with daily infusions of remdesivir.
“The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital.
Her comments were made this week during a video discussion about the trial results with other University of Chicago faculty members. The discussion was recorded and STAT obtained a copy of the video.
CNN followed with a report the same day, largely playing down the early results on remdesevir:
The University of Chicago said Mullane's comments constituted partial information.
"Partial data from an ongoing clinical trial is by definition incomplete and should never be used to draw conclusions about the safety or efficacy of a potential treatment that is under investigation," it said in a statement.
"In this case, information from an internal forum for research colleagues concerning work in progress was released without authorization. Drawing any conclusions at this point is premature and scientifically unsound."
There is no approved therapy for the Covid-19, which can cause severe pneumonia and acute respiratory distress syndrome in some patients. But the National Institutes of Health is organizing trials of several drugs and other treatments, among them remdesivir.
Remdesivir originally was developed as a possible tretment for SARS, MERS, and Ebola -- all diseases caused by coronaviruses. Reports CNN:
The drug, made by Gilead Sciences, was tested against Ebola with little success, but multiple studies in animals showed the drug could both prevent and treat coronaviruses related to COVID-19, including SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome).
Back in February, the World Health Organization said remdesivir showed potential against COVID-19. . . .
Trials of the drug are ongoing at dozens of other clinical centers, as well. Gilead is sponsoring tests of the drug in 2,400 patients with severe COVID-19 symptoms in 152 trial sites around the world. It's also testing the drug in 1,600 patients with moderate symptoms at 169 hospitals and clinics around the world.
Gilead said it expected results from the trial by the end of the month.
How is remdesivir expected to work against COVID-19. An article from statnews.com explains:
Remdesivir is an experimental antiviral that was first cooked up over a decade ago. In lab experiments, it’s shown potential against an array of viruses, including other coronaviruses, so it was sped into clinical trials in the early days of the pandemic.
The drug is designed to interfere with the process the virus, called SARS-CoV-2, uses to make copies of itself. The resulting copies of the virus lack their full RNA genome, so they can’t go on to replicate themselves or infect other cells.
Inspired by the West African Ebola outbreak, Gilead once pushed remdesivir as a potential therapy for that infection. But in a clinical trial, remdesivir did not produce the survival benefits that two other drugs did, and it was dropped as an Ebola therapy.
In a UAB press release, Whitley makes clear that the fight against COVID-19 is a wide-ranging team effort:
“The collaboration between UAB, our colleagues at Southern Research (also located in Birmingham, adjacent to the UAB campus), Vanderbilt University and the University of North Carolina, along with our pharmaceutical partner Gilead Sciences, is indicative of our collaborative approach to respond to outbreaks in real time, and in helping communities worldwide fight 2019-nCoV. This is a prime example of how the research we are conducting at UAB plays a critical role in treating patients on a global scale and our contribution of substantial scientific advances,” Whitley continued.
If the COVID-19 battle is won -- perhaps via remdesivir -- the world will need to remain on alert for similar threats, Whitley says, in an article at wbhm.org. He notes that UAB is involved in a clinical trial at Wuhan, China, where the novel coronavirus is believed to have originated:
Dr. Richard Whitley is the lead researcher and distinguished professor of pediatrics at UAB. He says they’ve tested the drug on a few patients in the U.S., but the trial in Wuhan is the first time they’ll test it on large numbers of people.
“The drug has been released on what we call a compassionate plea basis for a few patients in the United States who were sick. And those patients all did well,” Whitley says. “But we don’t know whether it was the effect of the drug or the natural healing process that took place in those patients. So we need the data from this controlled study.”
|Dr. Richard Whitley|
Whitley says as of right now researchers aren’t using mortality rate as a benchmark to determine whether remdesivir effectively treats the coronavirus. Instead, he says they’ll track whether it works based on the resolution of respiratory illness and the prevention of complications from a respiratory illness. . . .
Whitley says while scientists didn’t predict the magnitude of the coronavirus, he’s not surprised.
“What we need to be aware of is that the National Institutes of Health anticipated that we would see emerging infections occur in the United States, and this is a classical example of it,” Whitley says. “Because of climate change we’ll see diseases like dengue. We’ve already seen West Nile virus in the United States. We’ve seen a few sporadic cases of Zika and we’ll certainly see chikungunya. So we’ve got to be prepared and that’s what we’re trying to do.”