June 11, 2020
Clinical trials put potential COVID-19 treatments in front of patients
Trials at VCU take aim at reducing hyper-inflammatory response and shortening the course of COVID-19.
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Since COVID-19’s onset, Virginia Commonwealth University researchers and doctors have homed in on several drugs in the hopes of finding effective treatments against the novel coronavirus.
And since Virginia had its first cases of COVID-19 in March, volunteers have enrolled in drug treatment trials that will advance clinical care for all COVID-19 patients. Among the seven clinical trials VCU has activated to date are studies of two types of drugs: Those with the potential to stop the body’s hyper-inflammation response to COVID-19 pneumonia or those with the potential to shorten the disease’s course.
Armed with years of research experience and the reputation of VCU as a research institution, physician-scientists recently launched three new studies. Initiated by a trauma surgeon, a liver specialist and a pulmonologist, the new trials speak to the breadth and depth of VCU’s research capacity — and the continued response shown by VCU Health in fighting COVID-19.
Prioritizing studies according to science
Like other drugs being studied for their usefulness against COVID-19, the latest drugs had already undergone trials for the treatment of other diseases, meaning trials against the coronavirus could activate quickly and safely.
“With COVID-19, we were faced with a virus that had no approved treatments,” said Marjolein de Wit, M.D., a critical care physician specializing in mechanical ventilation and acute respiratory distress syndrome and the principal investigator for two of the studies. “Many drugs have shown promise for similar diseases in a lab setting and in small studies, but broader clinical trials are needed.”
Early on in the fight against COVID-19, scientists and doctors organized a committee, led by the C. Kenneth and Dianne Wright Center for Clinical and Translational Research, to prioritize and activate drug treatment trials to bring the best possible options to VCU Health patients and contribute to international data analysis.
One of the reasons I'm so proud to be at VCU is that we’re at the ready to do all these studies. It’s not going to be one thing, one drug or convalescent plasma, or a vaccine that solves this. It's a myriad of different treatments at different stages of the disease that is going to help, and VCU has been able to bring many of the treatments here.
Remdesivir was the first brought to VCU in March for two trials, and early national results showed enough promise to make it one of the first treatments for COVID-19 to receive an emergency use authorization from the U.S. Food and Drug Administration. These studies concluded in May.
In April, a trial with sarilumab, led by de Wit, and another with canakinumab began. Both of those trials target the inflammatory response brought on by COVID-19 that may exacerbate lung injury and the chances of death. The canakinumab trials were expanded recently to include patients at VCU Health’s Community Memorial Hospital in South Hill, bringing cutting-edge treatment options to rural Southside Virginia.
Now, three new national studies give patients even more treatment options:
- CM4620-IE, manufactured by CalciMedica Inc.
- MSTT1041A and UTTR1147A, manufactured by Genentech Inc.
- Hydroxychloroquine, sponsored by the National Heart, Lung, and Blood Institute at the National Institutes of Health
“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 principal investigator for the CM4620-IE study. “It’s not going to be one thing, one drug or convalescent plasma, or a vaccine that solves this. It's a myriad of different treatments at different stages of the disease that is going to help, and VCU has been able to bring many of the treatments here.”
Leveraging connections, expertise to fight inflammation
This isn’t VCU researchers’ first foray with any of the drugs activated for COVID-19 trials.
A lot of background work goes into studying which drugs researchers think will work best, said Benjamin Van Tassell, Pharm.D., vice chair for clinical research and professor in the Department of Pharmacotherapy and Outcomes Sciences in VCU’s School of Pharmacy.
“When the COVID-19 pandemic started and there were these preliminary signals that inflammation might be part of the disease process, we were fortunate in that we already had experience with a lot of the medicines that were under investigation, not just for heart disease, but that might also be relevant for the treatment of COVID-19,” Van Tassell said. “From that perspective, we were fortunate to be at the right place at the right time with the right type of experience.”
Van Tassell and Antonio Abbate, M.D., Ph.D., a cardiologist and principal investigator on the canakinumab trial, have been studying anti-inflammatory drugs for more than a decade for their potential in curbing the body’s inflammation response to heart disease.
“The virus destroys the cells within the lung, and when those cells die, they create a huge inflammatory response,” said Ferrada, principal investigator for the CM4620-IE study. “And that's why people have respiratory distress and are put on the ventilator.”
Ferrada was able to bring her study to VCU through her work on other clinical trials, a recurring theme in COVID-19 trials, where VCU researchers’ experience in treatment trials has created the infrastructure for a rapid response to the pandemic — and brought potentially lifesaving treatments to VCU Health patients more quickly.
“[The manufacturer] knows that our center has been successful in recruiting patients, that we have a good team,” she said. “And that's how we got offered the opportunity.”
Patient-centric, holistic care
VCU Health patients who meet qualifying criteria for a COVID-19 drug treatment trial are offered the opportunity to participate. Since trials began in March, about a third of patients diagnosed with COVID-19 at the hospital have agreed to participate.
“We’re very grateful to patients for their willingness to participate in these clinical trials,” said Arun Sanyal, M.D., a liver specialist and the principal investigator for the MSTT1041A and UTTR1147A trial. “Research advances science and improves public health for all, and the decision to join a trial is an important one.”
Sanyal is a faculty member at the Wright Center, which supports clinical research at the university and leads the committee on COVID-19 trials.
The clinical trials are randomized, meaning some patients in the study get a placebo, and they join networks of trials across the country that aggregate patient data in hopes of understanding the drugs’ impact on the coronavirus.
The researchers underscore that “dozens, if not hundreds” of VCU physician-scientists, researchers, health care workers and support staff have been stepping up to make these clinical trials happen.
“Each one of these trials represents an enormous amount of tireless work from clinical staff who are committed, not just to caring for their own patients, but to improving treatment for everyone in this pandemic,” said Peter Buckley, M.D., the dean of VCU’s School of Medicine. “We’ve seen promising results from remdesivir, but we’re not stopping there.”
Mary Kate Brogan contributed to this report.
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