Editor’s note: Researchers have recently released some positive results from early trials of remdesivir being used as a treatment for COVID-19, with evidence that the drug may help patients recover more quickly. On Friday, May 1, the U.S. Food and Drug administration issued an emergency authorization for the drug to be used to treat patients with a severe case of the virus. This story has been updated from the version published in our May print issue.
VCU’s Arun Sanyal leads research on a drug trial for COVID-19 treatment. (Photo by Jay Paul)
Arun Sanyal is practicing science but offering hope. He’s a gastroenterologist, a liver specialist and an internal medicine professor at Virginia Commonwealth University’s medical school, as well as a researcher with the VCU Massey Cancer Center. Emergency medicine is not his specialty, but Sanyal is playing a critical role in the COVID-19 pandemic, serving as principal investigator in trials of a drug that may treat the virus.
The drug is remdesivir, which is thought to stop the virus from replicating. VCU is one of several institutes studying remdesivir, which is produced by California-based Gilead Sciences Inc. At VCU, researchers are assessing the drug’s effectiveness in treating people with the virus who are sick enough to require hospitalization, as well as another group of hospitalized patients whose symptoms are severe enough to require placement on oxygen. The trials began at VCU on March 24.
It’s being offered to patients here courtesy of Sanyal, who wanted to do whatever he could to help in this time of pandemic. “It’s turned my life upside down,” he says. “I’m not an infectious disease doctor. I’m not a critical care doctor.”
Earlier this year, Sanyal “watched in dismay” as the virus spread across the globe, and he realized how unprepared the United States was. “I knew the cat was out of the bag; I knew that something had to be done.”
While he’s not the doc to treat you in the ER, Sanyal is used to dealing in life-and-death medicine in his work as a transplant doctor, and he has extensive experience in clinical trials. He looked around the state and saw that no Virginia medical center was involved in trials that “looked very promising,” so he decided to see what he could do. “I figured I should put my skill set to work, so I reached out to Gilead.”
Paperwork was expedited, and the university received approval within days instead of weeks.
Sanyal says that in the clinical trial for which Gilead released results this week, the same trial VCU is participating in for patients with severe COVID-19, VCU Health has enrolled 21 participants. In a second trial for patients with moderate symptoms, 15 participants had enrolled as of April 30.
“These trials compared administering a five-day and a 10-day dosing duration for treatment at 180 sites, including VCU Health,” he says. “Both treatments were effective, so somewhere between 55% and 65% of people fully recovered within the 28-day time frame that the study followed the patients. A similar number, between 55% to 60% of the patients, got discharged from their hospital during that time. Very importantly, the trial had between an 8% to 11% mortality rate across the sites. So, compared to historical controls who had similar severity of disease, this seems encouraging.
“This suggests that the five- and the 10-day treatment are about equally effective. The side-effect profile is similar but manageable. People who are earlier in the course of their disease seem to do better. So, for example, if patients were less than 10 days from the onset of their symptoms when they were admitted and started on the drug, those patients did better than patients who had already been sick for more than 10 days.”
Remdesivir, which is administered intravenously, is not something you can just pick up at the pharmacy. VCU will continue to enroll patients in the study, “until somebody says stop,” he says.
Sanyal notes that he’s just part of a team at VCU that’s helping heal people in a pandemic. “We have an army of people here, of incredible providers who are here to do their part.”
They’re all in a war, and there are casualties among the healers, along with a lot of anxiety. “I pray for them,” he says, “and yet they are coming into work every day.
“I see an extraordinary degree of people pitching in. Sometimes you must tell people to take it easy for now. Everybody doesn’t have to be on the front line all at once.”
We’re all in it together, says Sanyal. We need to maintain social distancing, wash our hands, take this news seriously and actually act on it. “It’s a little frustrating when you see people putting their lives on the line, and you see others who don’t seem to care,” he says.
Sanyal adds that the pandemic needs to be tamed as soon as possible to improve the odds for people who have other health issues. People with cancer need chemotherapy, people in kidney failure need treatment. Laboratory studies and checkups had been placed on hold until May 1, and that put people at risk. “We signed up for this, but the other patients did not sign up for COVID-19, but their care is also getting impacted,” he says. “As a doctor, it really bothers me.”
About Remdesivir
MAKER: Gilead Sciences Inc.
USE: Investigational only
WHAT IT DOES: An intravenous antiviral treatment that inhibits viral replication, it has shown promise in limited studies in animals against MERS and SARS, pathogens that are similar to COVID-19. It also has been tested in humans as a treatment for Ebola virus.
STUDIES: VCU Health is one of dozens of sites across the world that have been approved since March for clinical trials involving thousands of people.
IT’S ALSO AVAILABLE TO CHILDREN AND PREGNANT WOMEN: In early April Gilead reported that it had made the antiviral available on an “individual compassionate use basis” to more than 1,700 children and pregnant women.
PRODUCTION: Gilead says its manufacturing timeline for the antiviral is six months — a halving of its previous production timeline. It says it has about 1.5 million doses in stock or in final production stages, and the company estimates that could provide treatments for 140,000 patients, depending on study results.
LEARN MORE: Visit gilead.com for more on the treatment. See clinicaltrials.gov to locate trial sites.
Sources: Gilead Sciences Inc., National Institutes of Health
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