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Contributed by the C. Kenneth and Dianne Wright Center for Clinical and Translational Research

It isn’t how anyone expected to spend 2020. But for the hundreds of researchers at VCU, many of them also practicing doctors, COVID-19 required a drastic reorganization of priorities, processes and protocols.

Petri dishes were frozen. Study plans were amended. Some research pivoted. And by fall 2020, more than 50 new projects had emerged to combat the new virus on multiple fronts. Research projects that once took months to get off the ground took days.

One year later, there’s only one drug approved to treat COVID-19, and VCU helped test it. And of the handful of drugs authorized for emergency use, two had clinical trials at VCU Health. VCU Health will soon participate in a national vaccine trial for pregnant women. And the results of VCU studies regularly refine and shape what we know about the virus.

“Our researchers and administrators really stepped up to the plate in every way,” said Dr. F. Gerard Moeller, director of the C. Kenneth and Dianne Wright Center for Clinical and Translational Research. “It’s not a scenario that individual researchers could plan for, but they’ve managed it well.”

Researchers work quickly to find COVID-19 treatments and amend studies

In March 2020, as VCU Health prepared for its first surge of patients, no treatments existed for COVID-19. VCU research teams mobilized to contribute to the global search.

“We wanted to prioritize the studies that were likely to have a large impact,” said cardiologist Antonio Abbate, M.D., Ph.D., a trial lead. “Not only an impact for our patients, but . . .  everybody else in the U.S. and possibly worldwide.”

With decades of clinical research under their belts, doctors like Arun Sanyal, M.D., a liver specialist, helped bring some of the most promising trials to VCU Health. That included remdesivir. A day after Governor Ralph Northam ordered nonessential workers to stay home, VCU announced it was partnering with other universities and a pharmaceutical company to test the experimental drug on patients with moderate to severe symptoms of COVID-19.

In May, with data provided in part by VCU, the FDA issued emergency use authorization for remdesivir. In October, it became the first drug with full approval for use. The drug has since been distributed to hospitals across the United States.

By summer, five drug trials were up and running at VCU, giving eligible patients a number of treatment options.

“One of the reasons I’m so proud to be at VCU is that we’re at the ready to do all these studies,” said Paula Ferrada, M.D., a trauma surgeon and the principal investigator for one of the studies. “It’s not going to be one thing . . .  that solves this. It’s myriad of different treatments at different stages of the disease that are going to help, and VCU has been able to bring many of the treatments here.”

Many researchers pivoted to incorporate the effects of COVID-19 into their studies or to research the secondary health impacts of the pandemic, such as addiction, abuse and access to health care. The mandated remote work environment offered new opportunities for VCU researchers to study the benefits of and challenges to telehealth, which could revolutionize how medicine is practiced.

“This is a bizarre, probably once-in-a-generation experience with many people sheltering in place, delaying medical care, contending with a uniquely stressful situation,” said John Ryan, Ph.D., a professor in the Department of Biology and VCU’s associate vice president for research development. “There’s a lot of important health research coming out of that already.”

More trials bring more options for patients

Trials at VCU Health continue to contribute to urgently needed COVID treatments.

Through the work of Dr. Jeffrey Donowitz, VCU joined the first wave of hospitals in the U.S. to use convalescent plasma. In this treatment, plasma from a COVID-19 survivor is transfused into someone who’s still sick in hopes that the antibodies in the donor plasma will attack the virus. In August, convalescent plasma became one of fewer than 10 treatments to receive emergency use authorization by the FDA.

Dr. Michael Donnenberg, senior associate dean for research and research training at VCU School of Medicine, initiated a promising trial studying an antibody drug cocktail to prevent the transmission of COVID-19 between household members. And pulmonologist Marjolein de Wit, M.D., began a trial of the same two-drug cocktail as a treatment for hospitalized COVID-19 patients.

In November, de Wit’s treatment joined the ranks of treatments authorized for emergency use. That meant three of the studies undertaken at VCU Health had proven so promising that the FDA granted treatment approval or authorized the treatment for emergency use.

Another trial, led by Dr. Sanyal, is testing three drugs — infliximab, abatacept and cenicriviroc — to see if they can help control the dangerous inflammation doctors have seen in COVID-19 patients.

Researchers at VCU Health are always looking for the next, best treatment. Next up — a clinical trial of the COVID-19 vaccine on pregnant women.

COVID-19 trials expanded access geographically, demographically

In May, clinical trials for some experimental drugs expanded to VCU Health Community Memorial Hospital in South Hill, Va., offering more treatment options to our rural communities.

And VCU Health’s medical language services program expanded to accommodate the need for more interpreters and translators. This meant Spanish speakers could participate in trials.

By mid-summer over 130 patients were enrolled in COVID-19 trials. In August, of the COVID-19 patients hospitalized at VCU Health, 25% were enrolled. Even more patients have volunteered biological samples and data for lab studies and biobank registries.

Currently, there are:

• 16 clinical trials for 12 novel treatments of COVID-19
• 8 investigator-initiated lab studies of COVID-19
• 255 patients enrolled in COVID-19 clinical trials
• 2,388 patients enrolled in COVID-19 lab research studies

“In many ways, this unprecedented event is going to make research better at VCU,” Dr. Moeller said. “We haven’t just contributed to the body of knowledge about COVID-19, we’ve learned more about how to make clinical and health-related research work for patients, for researchers and for the institution itself.”

This story was adapted from one originally published in NEXT Magazine under the headline “The great shake-up.” For more stories like this, visit MCVFoundation.org/next or visit the COVID-19 research section of our news center.