Two decades of clinical trial expertise gave UCI and UCI Health an investigative edge when the pandemic hit 

Back in mid-March, when COVID-19 became a worldwide crisis, UCI Health clinicians were poised to quickly begin working on possible treatments to tame the deadly virus.

For the past two decades, UCI has received clinical trial funding from the National Institutes of Health, and in that time, the university has built up a clinical trial infrastructure capable of meeting the demand for trials of coronavirus treatments and therapies.

Most recently, the UCI Center for Clinical Research opened in the summer of 2019 after three years of planning and just in time to respond to the pandemic. It heralded a new era in UCI Health’s efforts to expand access to breakthrough therapies by accelerating clinical trials – research studies in which people volunteer to test novel ways of preventing, detecting and treating diseases.

“This [launch] was extremely timely,” says Dr. Daniela Bota, vice dean of clinical research and medical director of the center, which now has 75 principal investigators and 120 clinical researchers on staff. “When COVID-19 hit, we had some advantages.”

By May 1, six weeks after the coronavirus was declared a global pandemic, UCI Health had become one of the first designated sites in the country to start conducting research into the utility of remdesivir – an investigational, broad-spectrum antiviral medication – as a potential treatment for COVID-19.

A short time after that, on May 19, UCI Health began its second coronavirus clinical trial, this one to determine the effectiveness of aviptadil in critically ill individuals with acute respiratory distress syndrome. The drug has a 20-year history of safe use in humans for lung ailments.

Since then, UCI Health has initiated four more clinical trials to fight different aspects of the disease caused by SARS-CoV-2, Bota says. One involves developing an inhaler to keep patients off ventilators. Another examines ways to prevent UCI Health workers from getting sick. Yet another study is assessing the efficacy of convalescent plasma – blood fluid from people who have recovered from COVID-19 – injected into ailing individuals.

“And there are more [coronavirus] clinical trials on the way,” says Bota, adding that nondisclosure agreements do not permit her to elaborate. But in one, she says, a local company is working to come up with a vaccine.

The foundation for those trials was first laid 20 years ago. In 1999, UCI was one of 80-some centers funded by the NIH to support research into clinical trials. And then, in 2010, UCI earned a large grant that allowed the formation of its Institute for Clinical and Translational Science.

“We were already doing community outreach and training the next generation of investigators. We had relationships with local hospitals and patient advocacy groups and the Orange County Health Care Agency,” says Dan Cooper, ICTS director. “So when the pandemic struck, we were ready.”

Over the past two decades, UCI has been awarded about $90 million to support clinical research, he says. In fact, the university was receiving so much funding and had so many projects that administrators realized they needed a better organizational structure. So they established the Center for Clinical Research.

“We invested the time, energy, skill and talent into building the center, and then we were able to develop our own investigator-initiated trials, not just ones developed by drug companies,” Cooper says.

Today, the CCR handles the daily oversight of clinical trials, while the ICTS strives to improve the process by examining trial design and training investigators on how to ensure that their projects are approved. Those two groups, combined with UCI’s Chao Family Comprehensive Cancer Center, give the university a major advantage in conducting trials and enhancing patient care.

Most clinical trials at research hospitals, Bota says, can take up to nine months to launch. But because of the groundwork laid by UCI Health with the opening of the Center for Clinical Research, that time has been slashed to three months or less.

“The idea was for us to facilitate clinical trials,” says Bota, a neuro-oncologist who made a name for herself with groundbreaking research on glioblastoma, the most aggressive form of brain cancer. “At other universities, they’ll have one study here, one study there, but no central office and no ability to accelerate the process.”

By the onset of the pandemic, the CCR had remedied that at UCI Health. “We had this structure, and we had established relations with the majority of big pharmaceutical companies,” Bota says. “Second, we had a single point of contact. And third, we had a well-oiled system in which studies were already staffed and defined.”

All noncancer clinical trials at UCI Health go through the center and involve multiple physicians with different clinical interests. For example, the principal investigators on the remdesivir trial are Dr. Alpesh N. Amin (chair of medicine, hospitalist) and Dr. Lanny Hsieh (infectious diseases), while Dr. Richard Lee (pulmonary and critical care) heads up the aviptadil trial.

Dr. Donald Forthal (infectious diseases) and Dr. Minh-Ha Tran (transfusion medicine, pathology) are leading the clinical trial of convalescent plasma. The substance is seen as a possible treatment for COVID-19 until a vaccine is developed, Bota says.

It confers “passive immunity,” she notes, and can shorten the amount of time a critically ill coronavirus patient has to be on a ventilator. Convalescent plasma is also eligible for compassionate use in people who don’t meet certain criteria to participate in clinical trials.

Although the pandemic has put a focus on COVID-19 research, UCI Health boasts an impressive depth and breadth of studies.

The Center for Clinical Research currently oversees about 300 industry-funded interventional clinical trials – those with individuals receiving experimental treatments. These trials are underway in 12 departments, including dermatology, urology, neurology and obstetrics-gynecology. And there are an equal number of research studies in progress that do not yet involve humans.

“Our portfolio is very wide,” Bota says. “Much of our work lies in developing novel, cutting-edge cellular and genetic engineering therapies for life-threatening diseases.”

She’s quick to credit a critical component of clinical trials: the people who opt to join them. 

“Many patients come to UCI because of our clinical trials,” Bota says. “They are extremely generous and want to participate in them. Many have publicly said how much potential hope we’re bringing everybody because they have direct access to what we offer.”