Clinical trials for COVID-19 vaccines and treatments are underway at two Arkansas hospitals, while a third is distributing a new treatment and all three are distributing vaccines.
Their goal? To keep the infected from overwhelming the health care system.
The hospitals also predict that demand for this kind of work, which has been done quickly out of necessity and accomplished with much collaboration, will dominate the landscape for the next few years.
The University of Arkansas for Medical Sciences in Little Rock is conducting a trial for a vaccine developed by Janssen Pharmaceutical Cos. of Beerse, Belgium, which is owned by Johnson & Johnson of New Brunswick, New Jersey.
The hospital also has a faculty member serving on the National Vaccine Advisory Committee and another serving on the Food & Drug Administration’s Vaccines & Related Biological Products Advisory Committee. The FDA panel recommended emergency use authorization be granted for the Pfizer and Moderna vaccines that are being distributed now.
The Moderna vaccine has a second Arkansas tie as well: A trial for it is underway at Baptist Health in Little Rock.
Meanwhile, Unity Health in Searcy hasn’t been involved in any coronavirus-related clinical trials, but it has been distributing a treatment that’s been approved for emergency use.
UAMS and Baptist representatives declined to disclose how much money is being spent on various clinical trials but said they are paid for through a mix of federal and private funds.
“We do report grant funding, but these clinical trials are sponsored by industry, which means they are conducted through contracts, so the dollar amounts aren’t known until the very end, and it is a years-long process,” David Robinson, communications manager for the Translational Research Institute at UAMS, told Arkansas Business. He added that UAMS is very active in several national trials, and is besting many other testing sites in enrollment in a few of them.
The institute’s director, Dr. Laura James, said it could lay claim to eight clinical trials for COVID-19 treatments, most of which are continuing and all of which are inpatient. Some began to provide information in May or June, while some are just getting started and others have been underway for a month or two.
James said more than 300 people participated in clinical trials at UAMS last year. Not all have been in COVID-related trials, but most have.
“Looking at our overall enrollment for what we typically see in a year, we are as busy this year with this type of research study as we’ve ever been before,” she said. “So it’s a wide variety of trials. Some of them are looking at a type of antibody treatment that would try to reduce the inflammatory responses associated with COVID. And they’re really just a broad expanse of different strategies trying to fight the COVID infection and to reduce complications.”
Challenging, Exciting Times
“I think one of the gratifying things to me during this very challenging year is just the number of physicians that have come forward and volunteered to lead these studies. It’s a challenging time, but it’s also an exciting time because you see science in action and physicians really wanting to be part of that,” James said.
About 30 people at the institute are involved in this clinical trial work.
One of the physicians she referred to is Dr. Nikhil Meena, who has already led two treatment trials that wrapped up in October and November.
“There are multiple reasons why a university our size needs to be enrolled in studies like this,” Meena said. “First, we help figure out if the drug works or not for a patient, so we usually do Phase Two and Phase Three trials. We help define the efficacy and safety of a drug for the general population, so that people are not just releasing drugs into the market after Phase One trials. Then it also brings the university upfront and to the notice of both [the National Institutes of Health] and industry, and then that’s more investment into the university.”
Dozens of COVID-19 hospital patients were enrolled in the two trials that have ended. Meena said he was especially excited about another trial that is ongoing and ends in March.
With it, UAMS is the only site testing a drug by Asklepion Pharmaceuticals LLC that aims to help COVID-19 patients produce enough nitric oxide so that they don’t need to be intubated.
That drug has very few side effects, Meena said, and 60 participants will be enrolled in the trial.
He and James expect that UAMS will conduct many more coronavirus-related trials during the next few years, and Meena said he’s getting emails every day from pharmaceutical companies that want the hospital to test their COVID-19 drugs.
“The drugs we were using in March are not even close to what we’re using now. We’ve thrown everything but the kitchen sink at the disease,” he said. “We keep learning this doesn’t work, that doesn’t work. But the rapidity of how the scientific community has responded to this disease is incredible. We’ve already ruled out 15 or 16 drugs.”
Meena also said these trials have been different from typical trials in that it’s been easier to recruit ideal patients to enroll in them; those patients are already at the hospital. The COVID-19 trials are also more “data-rich,” so compiling data from them has been more time-consuming. On top of that, it can be difficult for researchers to access patients given isolation protocols that are in place to protect those who are not infected.
However, conducting trials and distributing vaccines aren’t all that Arkansas hospitals are doing in this pandemic fight. Unity isn’t conducting trials, but it began offering a new monoclonal antibody treatment the week of Thanksgiving, according to Chief Medical Director Dr. Roddy Lochala.
More than 100 patients have received the treatment so far, and it has decreased their risk of a severe outcome and hospitalization by a factor of four, he said.
Lochala also said health care providers outside his health system are reaching out and partnering with it to help their patients who have COVID-19.
While UAMS and Unity have focused on treatments, Baptist is focusing on COVID-19 prevention with the trials it’s conducting.
In addition to its two-year Moderna vaccine trial, Baptist has taken on two one-year trials sponsored by pharmaceutical company AstraZeneca. One of those trials began last month, and the other was set to start this month.
Both will test an antibody drug that aims to prevent infection as a vaccine would. The first is for the general population and the second is for those who share a household with someone who tested positive for the virus.
Dr. Richard Pellegrino, who runs the Baptist Health Center for Clinical Research, said hundreds will participate in its trials and about 35 people will be working on them for Baptist. The trials are funded by the federal government’s Operation Warp Speed, which gives the funding to companies so that they can pay hospitals to conduct these, he said.
Trial participants are paid, and there is no cost to them or to their health insurance providers.
Pellegrino said Baptist looks at these trials as a service it can provide to the state, and as “an opportunity to access possibly effective experimental medicines.”
He said that preventing COVID-19 infections is a job for both the science and business communities. “It’s really going to be a team effort between many companies to be able to make enough [vaccine] doses for the whole world. … So this is not only a scientific enterprise, but it’s a big business challenge too, and a manufacturing challenge,” Pellegrino said.
“The vaccines and monoclonal antibodies are not easy to make. So to scale up to millions of doses is not easy, and then you have the distribution issue. It’s an effort that’s really a partnership between the scientific and business communities to be able to make this work.”