COVID-19: Questions and answers with Drs. Kontos and Bhardwaj

Dr. Michael Kontos

Dr. Hem Bhardwaj

 

 

COVID-19 can have a serious cardiovascular impact on patients. To learn more about the relationship between the novel coronavirus and heart health, we spoke with Pauley faculty Dr. Michael Kontos, medical director of the Coronary Intensive Care Unit and president of the Virginia chapter of the American College of Cardiology, and Dr. Hem Bhardwaj, director of echocardiography and inpatient care. They share their expertise and insight below.

 

 

 

Q. Individuals with existing health conditions, including cardiovascular disease, appear to be most at risk for severe complications from COVID-19. Can you elaborate?

A. Studies have shown that patients infected with COVID-19 who have underlying cardiovascular disease are at increased risk for mortality. In addition, cardiac risk factors, specifically hypertension and diabetes, have also been associated with higher risk. It is unclear if this higher risk is related specifically to these risk factors or because the patients with these risk factors tend to be older and have other associated comorbidities.


Q. It’s also been suggested that COVID-19 can cause cardiac injury in otherwise healthy patients. How does the coronavirus affect the heart?

A. Coronavirus affects the heart indirectly, and less commonly via its direct infection of the heart. Elevation of a specific cardiac biomarker called troponin, which can be detected when there is myocardial injury, has been associated with increased mortality in patients infected with COVID-19. Myocardial injury likely occurs as a result of patients having underlying coronary disease who are now under significant stress from their infection. Less commonly, it results from a direct effect on the heart due to the inflammatory reaction that is seen in patients with severe COVID-19.

There have been a number of reports of patients who present with ECG abnormalities that are consistent with an acute heart attack who, when they undergo coronary angiography, do not have significant heart blockages. This indicates that the ECG abnormalities are likely the result of an inflammation of the heart rather than a true heart attack.


Q. What findings are cardiologists observing in COVID-19 patients who receive echocardiograms relative to those without COVID-19?

A. There is limited data on patients who have had an assessment of heart function who have COVID-19. In general, they have shown relatively normal function early in the course of the disease, with some patients with severe infection developing heart dysfunction. In this small group, patients who recover from the infection have recovery of heart function, although data is currently limited.


Q. Are there any treatments for COVID-19?

A. There are a number of potential treatments for COVID-19 that have been in the news that are currently undergoing investigation. One that has been frequently commented upon is hydroxychloroquine, which is a commonly used for the treatment of lupus, and chloroquine, which has been used to treat malaria. Although initial small studies suggested a possible benefit, more recent larger trials have cast doubt, with some even indicating a harm with treatment. Larger, randomized studies are clearly needed as both drugs can have significant side effects. Other drugs that are undergoing investigation include antiviral drugs such as remdesivir (with VCU being one of the first institutions to be included in these trials) and anti-inflammatory drugs.


Q. What questions do your patients ask about COVID-19, and what are you telling them?

A. Patients often ask what symptoms to look for. Fevers, fatigue, cough and shortness of breath are common symptoms; however, gastrointestinal symptoms have also been noted. Treatment in general is symptomatic, with approximately 85% of patients infected having self-limited infection and not requiring hospitalization. Approximately 15% of patients will develop more severe symptoms that require hospitalization. Patients also ask what they can do to decrease risk. Social distancing and frequent hand washing are key.


Q. During this pandemic, what measures are you taking to ensure heart patients stay safe but also receive any necessary clinical care? For instance, have you adopted/increased the use of telemedicine?

A. Because of recommendations on social distancing, VCU Health has implemented the use of telemedicine to provide cardiac care to outpatients while at the same time ensuring the safety of all patients and clinic staff. For those who do require further evaluation, the option of seeing a provider in the office is still available. Patients with severe symptoms should not avoid seeking care, as delay may lead to worse outcomes.


Q. Do you have anything else that you would like to add?

A. There has been some controversy over whether patients taking medications called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs), two common blood pressure and heart failure medications, have worse outcomes if they get COVID-19. Currently, there is no data indicating that these medications are harmful, and discontinuing them without physician consultation is not recommended. This is consistent with guidelines from multiple organizations, including the American College of Cardiology and the American Heart Association.

Visit vcuhealth.org/covid-19 to learn more about this virus.


Congratulations to our Pauley 2020 Richmond Magazine Top Docs winners! 

Richmond Magazine Top Docs 2020 Winners

Each year in Richmond Magazine’s Top Docs survey, Richmond’s medical community shares the doctors they would visit themselves or recommend to family and friends.

Cardiac electrophysiology

  • Kenneth A. Ellenbogen*
  • Jordana Kron
  • Richard K. Shepard

Cardiology 

  • Antonio Abbate
  • Phoebe Ashley

Cardiology (interventional)

  • Richard Cooke
  • Zachary Gertz*
  • Barbara Lawson

Surgery (cardiac)

  • Vigneshwar Kasirajan
  • Mohammed Quader

Surgery (thoracic)

  • Anthony Cassano*
  • Rachit Shah

Surgery (vascular) 

  • Mark M. Levy*

* Top vote-getter in the category


Welcome, Dr. Medalion!

Dr. Benjamin Medalion has joined the Department of Surgery as professor and chair for the Division of Cardiothoracic Surgery.

Dr. Benjamin Medalion

Dr. Benjamin Medalion

Medalion received his medical degree from Technion School of Medicine in Haifa, Israel, and completed his cardiothoracic residency at Carmel, Shaarei Zedek and Hadassah medical centers. He then joined the Cleveland Clinic Foundation, where he completed his cardiothoracic fellowship.

Medalion held a variety of positions at prestigious institutions, including the Edith Wolfson Medical Center in Holon, Israel, and Case Western Reserve University.

Prior to joining VCU Health, Medalion served as the director for cardiac surgery at the Ahuja Medical Center and the director of mechanical support and transplant surgery at the Harrington Heart and Vascular Institute at University Hospitals of Cleveland. Additionally, Medalion completed a surgical leadership certificate from Harvard Medical School in 2019.
Medalion’s expertise in adult cardiac surgery, including heart and lung transplantation, will continue to enhance the capabilities at VCU Health.


Better than blood?

Promising crystalloid solution may improve survival time of patients

The new crystalloid IV solution developed by Martin Mangino, Ph.D., is getting national attention because it revolutionizes resuscitation for hemorrhage shock. The PEG-20k solution can save the lives of patients.

Martin Mangino, Ph.D.

Martin Mangino, Ph.D.

Mangino, professor of surgery and associate chair for basic research in the Department of Surgery, and research director of the VCU Trauma Center started working on the project in 2010 when the military asked him to develop a new, low-volume crystalloid for use by the armed forces. “I put into practice what I learned in previous research to develop new solutions to preserve donor organs for transplantation,” he said.

Preclinical trials of the solution showed increases in survival even when compared to resuscitation with fresh whole blood. “It took the survival time from minutes to days,” Mangino said.

Take for example a soldier who is bleeding on a mountaintop in Afghanistan and needs immediate transport. The more stable that soldier is in the field, the better they will be in the hospital, Mangino said. “This new IV solution helps prolong a soldier’s stay in the field, which allows medics to take the time needed to transport the soldier to more definitive care at the forward field hospital.”

The research is funded by grants from the U.S. Department of Defense and the National Institutes of Health. The product is awaiting FDA approval for use in trauma patients with hemorrhagic shock and sepsis, and intensive care unit patients with critical illness. The solution can additionally be used in patients with sudden-death heart failure undergoing CPR.

Pre-clinical trials of the solution showed increases in survival even when compared to resuscitation with fresh whole blood.

This approach may improve patient survival, as well as normalize cardiac and brain functions after resuscitation from CPR. Currently only about 8% of patients survive out-of-hospital cardiac arrest and leave the hospital with normal brain function.

“We have a lot of applications we haven’t explored yet,” Mangino said. “We are going to put in the application with the FDA this year.”

First trials will be conducted in randomized testing at VCU when the solution receives an FDA exemption this year. Some patients will get PEG-20k, and some will receive the standard-of-care solution. “The military will probably get involved in trials, as well,” Mangino said.

Mangino is also studying applications of the IV solution in polytrauma, where someone suffers both a traumatic head or spinal cord injury and is losing large amounts of blood. “What this solution does is move water out of the cells and prevents swelling in the brain,” he explained. “It works by preventing cell swelling, which then opens capillaries and allows the body to exchange oxygen better.”

The trauma resuscitation fluid is “a game changer,” said Mangino, who is licensing the technology from VCU to his new company (Perfusion Medical LLC) to commercialize it. “It has such a dramatic effect when you compare it with the gold standard, whole blood. This is a big deal. We think we can save a lot of lives in the field and in the ICU. It’s a huge advancement.”


Drug trials highlight novel therapies for age-related cardiomyopathy

VCU leads recruitment efforts

VCU Medical Center is leading an international effort to screen patients with transthyretin amyloid cardiomyopathy (ATTR-CM) and enroll them into a clinical trial testing a novel therapy called AG10. Among 51 recruitment centers in the U.S. and abroad, VCU ranks among the top 5 in recruiting patients into the trial.

“Enrollment has been fantastic,” said Dr. Keyur Shah, chief of the section of heart failure at Pauley and medical director of VCU’s Mechanical Circulatory Support Program. “It’s given our patients access to treatment they wouldn’t have had, because the only drug that’s available, Tafamidis, is unaffordable to many.”

“These achievements in enrollment not only increase Pauley’s visibility, they highlight VCU Health’s access to novel therapies for patients across Virginia,” added Laura Cei, clinical research nurse coordinator in the Department of Internal Medicine.

Dr. Keyur Shah with a patient

Dr. Keyur Shah with a patient

Years ago, VCU Health made a commitment to the research, diagnosis and treatment of amyloidosis. Shah leads a renowned, multidisciplinary team of top physicians and surgeons in a center of expertise for patients in need of amyloidosis treatment and resources.

“We’re one of the leading enrollment centers in all of the U.S. because of a high population of referrals for TTR amyloidosis,” he said.
“Part of that has to do with improved recognition of the disease here in the community through outreach and education.”

Transthyretin amyloid cardiomyopathy is a rare, life-threatening heart condition affecting more than 400,000 people worldwide. The accumulation of an abnormal protein called transthyretin amyloid results in thickening and stiffening of the heart, which often leads to heart failure or even death.

Running through May 2023, a placebo-controlled clinical trial called ATTRibute is testing the efficacy and safety of AG10 in 510 adults with symptomatic ATTR-CM. An alternative to Tafamidis, the first FDA-approved drug to slow the progression of amyloid heart disease, AG10 was developed to bind the four arms of TTR protein and prevent it from turning into amyloid. The impact of AG10 versus the placebo is being evaluated in patients after 12 months and 30 months of treatment. At the end of 30 months, study participants may be eligible to receive AG10 with no placebo.

In addition to ATTRibute, two clinical trials recently underway and running through 2024 are testing ATTR-CM novel drugs called AKCEA-
TTR-LRx and Vutrisiran.

Participation in ATTRibute, and future trials, is a win-win for both patients and Pauley.

“By conducting these clinical trials at VCU, we are able to spread awareness of ATTR-CM,” Cei said. “We can also provide patients with a hub in which they can obtain ongoing support and continuing education about this disease.”

To learn more about amyloidosis and the VCU Health multidisciplinary team, visit vcuhealth.org/pauley-heart-center/our-expertise


Is food the best medicine for heart failure?

Researchers definitively link diet and heart health

Despite our satisfaction from polishing off a hearty breakfast or fast-food lunch, our hearts may beg to differ, statistically speaking. Preclinical and clinical studies at Pauley confirm what we’ve known for years: A diet high in refined sugars and saturated fats will likely catch up with our heart health.

Researchers looked at the effects of a diet rich in sugars and saturated fats, known as a Western diet, starting with a study published in 2015. “We were most interested in cardiac function — to see how the heart is affected by eating an unhealthy diet,” said principal investigator Dr. Salvatore Carbone, assistant professor in the Department of Kinesiology and Health Sciences, College of Humanities and Sciences at VCU. Carbone, a native of Italy, sought to determine if a diet rich in foods containing healthy fats, such as extra-virgin olive oil and tree nuts, that resembled the Mediterranean dietary pattern, could improve body composition, cardiac function and, ultimately, exercise capacity in people who were obese and had a specific form of heart failure called heart failure with preserved ejection fraction.

Pauley researchers have determined a diet rich in healthy fats improves body composition and cardiac function.

Pauley researchers have determined a diet rich in healthy fats improves body composition and cardiac function.

Also known as HFpEF, heart failure with preserved ejection fraction occurs when the heart pumps blood and contracts relatively normally, but is too stiff to fill and relax properly. About 6.5 million adults in the U.S. have heart failure, according to the Centers for Disease Control and Prevention, and about half of those people present with HFpEF. In the U.S., more than 80% of people who have HFpEF are overweight or obese. Importantly, to date, there are no drugs approved by the Food and Drug Administration to improve clinical outcomes in HFpEF, clearly highlighting the need to develop novel efficacious therapies.

Carbone launched a preclinical study in 2014. In a laboratory, he fed mice a high-sugar and high-saturated fat diet. Within eight weeks, the mice developed cardiac dysfunction and became obese. Importantly, when the mice were switched to a healthy diet with lower calories, the cardiac function returned to the baseline values, showing that the cardiac dysfunction induced by unhealthy diet is reversible, “suggesting there is hope — if you change your diet and your lifestyle.”

Carbone and his colleagues also wanted to know whether, independent of caloric intake, improving the quality of the diet could prevent the cardiac dysfunction.

In a follow-up study, the Western diet was modified. Unsaturated (read: “healthy”) fats were substituted for the saturated fats typically found in the Western diet.

After being on the “high-healthy fat” diet for eight weeks, which is equal to several years in humans, Carbone said, cardiac function was preserved and mice did not become obese, despite consuming the same amount of calories.”

After conducting the second round of preclinical research and observational study (i.e., without interventions) in patients with obesity and HFpEF, Carbone felt ready to launch a feasibility study to ensure that people would comply with a prescribed diet of increased unsaturated fatty acids. With pilot funding from Pauley and the VCU School of Medicine Department of Internal Medicine, he and his research team enrolled nine VCU Health patients in a 12-week dietary intervention aimed at having participants consume a recommended daily amount of foods rich in unsaturated fatty acids.

The results of the study, published last fall, demonstrated for the first time in scientific history that a dietary intervention aimed at increasing unsaturated fatty acid consumption was feasible and had the potential to improve cardiorespiratory fitness in people with severe obesity and HFpEF.

“Larger randomized controlled trials to test the efficacy of unsaturated fatty acids supplementation on cardiorespiratory fitness (i.e., exercise capacity) and clinical outcomes, as well as understanding the mechanisms through which unsaturated fatty acids may exert these beneficial effects are clearly warranted,” Carbone said in the journal article.


Discovery Series comes to Richmond

Panel discussion focuses on innovation and patient care

Each year, the MCV Foundation sponsors a Discovery Series in Williamsburg, Va., providing guests with immediate access to the latest exciting work of VCU Health scholars, researchers and clinicians. Last October’s event, the sixth in the series and the first in Richmond, highlighted innovative treatments and patient care.

More than 100 invited guests attended the inaugural Discovery Series RVA, an intimate occasion held at the Country Club of Virginia that included a welcome reception, program and discussion, strolling supper, and question-and-answer session.

Dr. Peter Buckley, dean of the VCU School of Medicine and interim senior vice president for VCU Health Sciences and interim CEO of VCU Health System, moderated the discussion, “The Doctor Is In: A Panel of Experts from VCU Health Discuss Innovative Treatments and Patient Care.” The multidisciplinary panel included VCU faculty Dr. Kenneth Ellenbogen, professor, Department of Internal Medicine, and chair, Division of Cardiology; Dr. Kelly Gwathmey, assistant professor, Department of Neurology; Dr. Jordana Kron, associate professor, Department of Internal Medicine, Division of Cardiology; Dr. Kandace McGuire, associate professor, Department of Surgery, Division of Surgical Oncology; Dr. Saïd Sebti, professor, Department of Pharmacology and Toxicology, associate director for basic research, Massey Cancer Center; and Dr. Gordon Smith, chair and professor, Department of Neurology.

From left: Panelists Dr. Kandace McGuire, Dr. Kenneth Ellenbogen and Dr. Kelly Gwathmey

From left: Panelists Dr. Kandace McGuire, Dr. Kenneth Ellenbogen and Dr. Kelly Gwathmey

From left: Judy Brown, Dr. Kenneth Ellenbogen and Carrie Mills

From left: Judy Brown, Dr. Kenneth Ellenbogen and Carrie Mills

The theme of the night was interdisciplinary collaboration, which Kron described as critical “both for scientific advancement and for patient-focused, family-focused clinical care.” Kron works with an interdisciplinary team of physicians in VCU Health’s sarcoidosis clinic. “The future of medicine,” she noted, “is teamwork to find new therapies for diseases and then bring those treatments to patients and their caregivers in a compassionate way.”

A highlight of the event, Kron and Ellenbogen each discussed innovations in the treatment of heart disease. Kron, a recent recipient of the American Heart Association’s Collaborative Sciences Award and a Pauley Pilot Research Grant, discussed what VCU Health is doing to address sarcoidosis, a debilitating systemic condition that can affect the heart and nervous system. Ellenbogen, a highly sought-after clinician, researcher and educator, described how VCU Health has developed a national reputation in the diagnosis and treatment of atrial fibrillation. “It was a great opportunity to share the knowledge and drive of the Pauley Heart Center faculty with the public,” Ellenbogen said of his participation.

“Bringing the Discovery Series home to Richmond was very exciting, and significant,” Kron added. “VCU plays such an important role both in downtown Richmond and in the surrounding communities, but sometimes people that live locally may not know all of the cutting-edge research and amazing patient care that is going on right here.”


Inaugural advisory board kicks off year of service

Goals include fundraising, “friend-raising” and advocacy

Fulfilling the vision of director Greg Hundley, M.D., the inaugural Pauley Heart Center Advisory Board held its kickoff dinner in November 2019.

“In addition to increasing engagement in our community in the mission of Pauley, I am excited to have a close network of professionals I can call on for advice,” Hundley said of the philanthropists, community leaders and business leaders who comprise the board. “I admire the unique and extremely valuable experience they bring to the table.”

Inaugural advisory board kicks off year of service Goals include fundraising, “friend-raising” and advocacy

From left: Dr. Greg Hundley, Rick Burton, Kathy Pauley Hickok, Dr. Kenneth Ellenbogen, Mitch Haddon, Nancy Belleman, Roger BoevŽ, Dr. George Vetrovec, Charles Reed, Dr. Vigneshwar Kasirajan, Ken Blaisdell, Marshall Orr.

Each of the board’s 12 members is eligible to serve two three-year terms to help Pauley implement objectives in the areas of education, research and clinical care. The board members’ formal duties include making the center a priority in their philanthropic giving, engaging their personal networks for fundraising or educational events, and advocating on behalf of the center to all constituents.

The well-rounded board includes individuals with deep ties to Richmond and who represent a variety of industries.

Roger Boevé, retired executive vice president of Richmond-based Performance Food Group, is the Pauley Heart Center advisory board chair. “I currently serve on several advisory boards and understand the power an advisory board can generate to support a cause,” said Boevé, a member of the Massey Cancer Center advisory board and the MCV Foundation Leadership Council.

Pauley Heart Center’s mission, he said, is critical and compelling.

“Heart failure affects millions and can affect anyone at any time,” Boevé said. “We are fortunate to have available in our area a world-class cardiovascular care center, equal to none. Each year, thousands of patients are treated here, ranging from noninvasive cardiology procedures to heart transplantation. The center has become known worldwide for its groundbreaking work.”

The advisory board will capitalize on Pauley Heart Center’s reputation for excellence through advocacy, “friend-raising” and fundraising.

A deep, personal connection to Pauley’s mission motivated Rick Burton to join the advisory board. His spouse, Mike, was successfully treated at Pauley for a persistent cardiac arrhythmia that confounded physicians in other practices. “A doctor friend sent us to Dr. Ken Ellenbogen at Pauley, who performed an ablation,” he said. “It returned Mike to a normal life in every way. Indeed, it’s certainly fair to say that it gave us his life back.”

Burton, a retired attorney, sees his role on the board as an ambassador for Pauley — both to make the community aware of the extraordinary work and research being done there and to encourage individuals and businesses to financially support Pauley’s mission.

For advisory board member Nancy Rosenthal Belleman, the opportunity to promote and connect Pauley’s services to the community proved irresistible. “As a former board member of the Jenkins Foundation [a grant-making foundation devoted to improving the health of greater Richmond], I’m attuned to underserved and uninsured populations in the city of Richmond,” she said. “The research arm of the Pauley Heart Center will directly impact those most in need.”

With 2020 underway, the advisory board is ready to get to work.

“This is an exciting time at Pauley,” Boevé said.


Congratulations to Dr. Thomas Porter, a 2019 VCU Alumni Star honoree.

Dr. Thomas Porter

Dr. Thomas Porter

The university-level award, given biennially by the VCU Office of Alumni Relations, recognizes outstanding alumni for their career and humanitarian achievements. Sixteen honorees were selected through faculty recommendations and alumni committees from across the university.

Porter, a former resident and cardiology fellow at the Medical College of Virginia, is the Theodore F. Hubbard Distinguished Chair of Cardiology at the University of Nebraska Medical Center. He has spent many years studying the efficacy of microscopic bubbles, known as microbubbles, combined with ultrasound imaging to break up blood clots. Interest in this work began in 1990 at VCU. At that time, he explored using tiny bubbles as an ultrasound-enhancing agent for imaging, work that he continued when he joined the faculty of UNMC in 1992.

Porter was in good company, sharing the spotlight with honorees Rodney F. Ganey, Ph.D., founder of Press Ganey Associates, and Dr. Ali Khan, VCU School of Medicine graduate and member of Doctors for America, American College of Physicians and Physicians for Human Rights, along with thirteen others.

Alumni Star recipients were honored Nov. 7, 2019, at the Science Museum of Virginia.

Read more about Porter in the Autumn 2019 issue of The Beat. For more information about the 2019 Alumni Stars, visit vcualumni.org.


VCU researchers begin clinical trials on investigational drug therapy for COVID-19

Virginia Commonwealth University researchers began two clinical trials in late March on a potential, experimental treatment for COVID-19, the novel coronavirus that has spread across the globe.

Dr. Arun Sanyal, a liver specialist and gastroenterologist at VCU Health, is leading clinical trials of an investigational drug for patients with moderate and severe symptoms of COVID-19 and the virus responsible for the disease, SARS-CoV-2.

The investigational antiviral drug remdesivir was developed by Gilead Sciences, Inc. and used experimentally to treat Ebola. Earlier this year, its use on a man hospitalized with coronavirus in Washington state piqued the interest of researchers globally. Remdesivir is an investigational agent; it is not approved anywhere globally and has not been demonstrated to be safe or effective for any use.

“We feel it is extremely important that drugs to be used for this potentially life-threatening disease be tested rigorously so we have good evidence of their efficacy, as well as their safety,” Sanyal said. “We are delighted to work with Gilead on this trial, and we look forward to generating the data that hopefully will help lots of people who have this condition.”

VCU Health is one of the handful of institutions in the United States to make these clinical trials available to patients who meet the criteria for this investigational drug.
“The selection of VCU as a site for this global trial reflects our ability to bring multidisciplinary care to clinical trials and in having the capacity, the breadth and the depth of expertise needed to manage these patients,” said Sanyal, a professor of internal medicine in the VCU School of Medicine.

Remdesivir has previously shown antiviral activity against other coronaviruses like Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) in vitro and in animal models. But clinical trials were never completed due to the lack of available study participants, and the investigational drug is not currently publicly available.

Remdesivir acts by mimicking the appearance of part of the virus and infiltrating the enzyme that viruses can use to replicate themselves. It is designed to slow the infection of healthy cells in a patient’s body. The trials are a chance not only to provide access to remdesivir, Sanyal said, but also to generate data on the investigational drug’s safety and effectiveness.

The trials represent a first-of-its-kind partnership among hepatology, infectious disease, critical care-pulmonology and cardiology departments at VCU.

VCU’s trials are enrolling participants with documented COVID-19 infection who have fever and symptoms warranting hospitalization. Doctors at VCU Health are administering the investigational drug intravenously in five- or 10-day regimens and following up 28 days later. There are two levels of acuteness being tested: moderate and severe, the latter defined as “someone whose symptoms require them to be on supplemental oxygen,” Sanyal said.

All patients and researchers know whether the patient is receiving the investigational drug therapy, and the majority of patients are receiving the drug. All participants in the trial for severe COVID-19 will receive the active drug. In the moderate COVID-19 trial, two-thirds will get the drug therapy for different durations of time. One-third — a control group — will receive standard-of-care treatment, not a placebo.

The trials represent a first-of-its-kind partnership among hepatology, infectious disease, critical care-pulmonology and cardiology departments at VCU. Sanyal leads the trials with a team of infectious disease doctors (Gonzalo M. Bearman, M.D., Michael P. Stevens, M.D., and Michelle E. Doll, M.D.), pulmonary critical care doctors (Marjolein de Wit, M.D., Lisa Brath, M.D., and Curtis N. Sessler, M.D.), researchers in inflammation (Antonio Abbate, M.D., Ph.D., and Benjamin Van Tassell, Pharm.D.) and VCU research and ethics staff.

“This has been really an exceptional team,” Sanyal said. “We were able to get the trial off the ground, meeting all of the complex regulatory requirements along the way, within a 72-hour time frame primarily because of the alignment of mission and vision and an extraordinary team effort from everybody involved.”

It is not one person’s trial, he added. The physicians, nursing staff, pharmacists and administrative staff came together to integrate the trial conduct with routine clinical care for eligible patients.

At VCU and VCU Health, the research represents just one response to a pandemic that has killed more than 350,000 people worldwide, including 100,000 in the United States. With no approved medications to treat the virus currently, there is an urgent need for effective treatments.

“These clinical trials and the ongoing research of nationally prominent universities like VCU will quickly advance how health care teams treat COVID-19 around the world,” said VCU President Michael Rao, Ph.D. “We are proud of our research and health care teams that are working hard to save lives and find solutions for patients with COVID-19.”

“These clinical trials and the ongoing research of nationally prominent universities like VCU will quickly advance how health care teams treat COVID-19 around the world.”

VCU Health is prepared for and is responding to the threat of the virus, and doctors are taking precautions to ensure the safety of all visitors, team members and patients, including those with suspected or confirmed cases of COVID-19 at the hospital. Those in the trials are isolated.

“Our team members at VCU and VCU Health have been actively searching for ways to combat COVID-19, a virus that has disrupted our lives and the lives of those we serve,” said Dr. Peter Buckley, dean of the VCU School of Medicine and interim senior vice president for VCU Health Sciences and interim CEO of VCU Health System. “Our teams are working seamlessly to make this investigational drug therapy available to those who are most affected by this virus.”

Sanyal, the principal investigator for the remdesivir trials, is a researcher at VCU Massey Cancer Center and the associate director of the KL2 program for training faculty in research at VCU’s C. Kenneth and Dianne Wright Center for Clinical and Translational Research, which oversees clinical trials at the university with the help of a $21.5 million National Institutes of Health grant.

The Wright Center, in collaboration with Sanyal’s team, developed a patient referral portal that allows doctors at other institutions to communicate with the trial team at VCU about possible participation for patients who meet the criteria — positive for COVID-19, hospitalized with a documented fever. If a patient from another health care provider qualifies, the patient could be eligible to transfer to VCU Medical Center to participate in the trial.

Learn more about Pauley Heart Center’s response to the COVID-19 pandemic in the fall 2020 edition of The Beat.