Researchers with the state’s two largest medical groups — Intermountain Healthcare and University of Utah Health — have embarked on twin clinical trials to investigate whether an anti-malaria drug helps in treating coronavirus patients.
The consortium of physicians said they plan to make the medication available to about 2,300 sick Utahns under the close supervision and tight controls that come with scientific research. They’re hoping their findings will prove useful not only in Utah, but around the world, as the medical community struggles to understand the drug’s place in combatting the pandemic.
Dr. Samuel Brown, principal investigator of one of the studies and a critical care researcher at Intermountain, cautioned that he does not anticipate the medication, hydroxychloroquine, will be a miracle cure in COVID-19 cases.
“The likelihood is that hydroxychloroquine does not have an effect,” he said Wednesday during a virtual news conference. “We hope it might have a moderate effect, but that’s not at all clear.”
However, the researchers say they understood the clamor for more information about the drugs during the current public health crisis.
“We want to test this in a pandemic. We want to know if it works. We want to get this out,” said Dr. Raj Srivastava, assistant vice president of research at Intermountain Healthcare and principal investigator of one of the trials. "These are our loved ones, just like they’re your loved ones.”
One of the trials will explore whether the drugs are effective for patients with such severe COVID-19 symptoms that they’ve been admitted to the hospital. This study will enroll about 300 patients across Intermountain and University of Utah hospitals and will treat them with either hydroxychloroquine or azithromycin to determine whether either drug helps them recover, according to Wednesday’s announcement.
The second set of trials will analyze the drugs’ impact on about 2,000 coronavirus patients who are able to manage their symptoms from home. Researchers will give patients hydroxychloroquine or azithromycin and look at whether the medications help keep these individuals out of the hospital. They’ll also examine whether hydroxychloroquine affects the way patients shed the virus and if the medication prevents them from passing it to other people in their households.
Patient enrollment has already begun, Srivastava said. Researchers are contacting people diagnosed with COVID-19 and alerting them that they might be eligible to participate in the study but also said people interested in the trials can find information about them online.
It’s not yet clear when the clinical trials will conclude, the experts said, explaining that the timeframe depends on how fast the disease spreads in Utah and how many patients are available for enrollment. Ideally, the virus will spread slowly through the community so the state’s health care system isn’t overburdened, Brown said. But that also means some of the research might take longer.
Dr. Rachel Hess, another lead researcher who helps direct the Center for Clinical and Translational Science at the University of Utah, said she’s aiming to have results on the viral shedding study fairly soon.
“We’re hoping to go soup to nuts in 10 to 12 weeks,” she said. “That just depends on being able to find enough Utahns who are willing to help us find these answers.”
Hydroxychloroquine, an anti-malaria drug, has been the subject of national debate in recent weeks as President Donald Trump has repeatedly promoted it as a promising treatment for coronavirus, even though most medical experts agree there is scant evidence of this.
Some of those same conversations are playing out in Utah, with the Utah Medical Association at one point sending out a recommendation — supposedly from state health officials — to use the drug for COVID-19 patients and then rescinding it a day later.
The drug is well understood by the medical community, having long been used to treat malaria, lupus and rheumatoid arthritis. But there are a number of potential pitfalls to prescribing it widely for coronavirus patients outside the bounds of a clinical trial, Brown said.
In rare cases, hydroxychloroquine can cause fatal heart arrhythmia and it can come with a host of other less serious, though unpleasant, side effects. If the drug doesn’t do anything to treat COVID-19, he said, then there’s no reason to run the risk of those possible effects.
“We know that they have side effects. We know that they seem to be manageable at an individual patient level,” he said. “But it ends up being a little bit of a spinning of a roulette wheel across the population.”
Because of that, researchers will check in daily with outpatient participants in the clinical trial and will look for potential drug interactions or heart problems that would put them at higher risk, explained Dr. Brandon Webb, another principal investigator and an infectious diseases physician at Intermountain Healthcare. And hospitalized patients will undergo electrocardiogram screenings to look for any heart issues, he said.
“We have multiple layers of safety monitoring in place, and we do have years of experience with these drugs that help us to predict fairly accurately in which patients do we need to be most aware of risk,” Webb said.
There are also some concerns that widespread use of the drugs outside clinical trials could give people “false confidence," causing them to abandon the social distancing precautions that are helping curb the virus’ spread, Brown said. Moreover, he explained, panic buying can create shortages of the drug and limit their availability to lupus patients, who have long relied upon them.
Srivastava offered reassurance that researchers have made sure their studies will not deplete the supply of hydroxychloroquine for people with lupus or others who depend on the medication. The trials are being internally funded by both involved institutions, although the researchers are working to land federal grants, they said.