Page 24 - RU RWJ Medicine Magazine • Winter 2021

Evidence-based
treatment did not exist with the onslaught of COVID-19; there- fore, clinicians relied on Federal Drug Administration (FDA)- approved therapies to treat the growing symptoms and began collecting the data needed to determine how to achieve the best outcomes for patients. The Clinical Research Center (CRC) at the medical school, a core resource across the university to facilitate and support clinical trials, was instrumental in the swift pivot from existing trials to the launch of multiple therapeutic studies in an attempt to treat the emerging virus.
“The clinical studies began rapidly, within three weeks of the stay at home order in New Jersey,” said Sunanda Gaur, MD, professor of pediatrics and director of the CRC. “When the surge began, our investigators needed a place with trained individuals who could quickly activate research studies, and the CRC provided that expertise.”
In addition to skilled staff, collaboration, infrastructure, and organization were key to a prompt and effectual response.
“We saw a significant mobilization of investigators who capitalized on their expertise to address different aspects of COVID,” said Céline Gélinas, PhD, senior associate dean for research and chair of biochem- istry and molecular biology. Dr. Gélinas explained that the mobilization led to the formation of COVID interest groups across Rutgers.
“The interest groups offered an opportunity for investigators to discuss approaches to understand the biology of the SARS-CoV-2 virus and its interaction with host cells, anti-viral drugs and vaccine development, epi- demiology, and other important aspects of COVID-19 research,” she said.
Three powerhouse clinician-scientists who previously never worked together have become leaders in the research of the virus in patients and health care workers, col- laborating on multiple studies: Martin J. Blaser, MD, Henry Rutgers Chair of the Human Microbiome, professor of medi- cine and pathology at the medical school and director of the Center for Advanced Biotechnology and Medicine at Rutgers Biomedical and Health Science (RBHS); Jeffrey Carson, MD, provost-New Brunswick, RBHS, Distinguished Professor of Medicine and Richard C. Reynolds, M.D. Chair in General Internal Medicine; and Reynold A. Panettieri Jr., MD, profes- sor of medicine at the medical school, vice chancellor, Clinical and Translational Sci- ence, and director, Rutgers Institute for Translational Medicine and Science.
The combination of their expertise into one efficient team has put the medical school, and Rutgers, at the forefront of both risk assessment and clinical studies, impacting health care delivery globally.
Dr. Blaser is internationally known for his research into the microbiome, but as a trained infectious disease physician, had the foresight to prepare for the soon-to-be pandemic. He reached out to the National Institutes of Health (NIH) in February 2020 before there were known cases in the United States, encouraging scientists there to pro- mote the formation of cohort studies, which are designed to collect data about affected populations and track them over time to de- termine risks associated with a disease. To- gether with his colleagues, Dr. Blaser drafted a supplement to an existing grant from the NIADD to commence the cohort study in health care workers who are critical to taking care of sick people, which puts them at very high risk of getting the infection.
Within weeks Dr. Blaser, Dr. Carson, Dr. Panettieri, and their respective teams worked to swiftly obtain approvals with
The Clinical Research Center (CRC) has managed 10 adult and eight pediatric studies related to COVID-19, including for the antiviral medica- tion Remdesivir (GS-5734TM), the first to receive official approval for treat- ment by the FDA in October. In New Jersey, the principal investigator (PI) was Ronald Nahass, MD ’83, clinical professor of medicine and an infec- tious disease expert in private practice, while Pinki Bhatt, MD, an instruc- tor and infectious disease physician in the Department of Medicine, was the site PI at Robert Wood Johnson University Hospital New Brunswick.
Three faculty members in the Division of Pulmonary Medicine and Critical Care in the Department of Medicine are leading multiple studies in the CRC: Sabiha Hussain, MD, assistant professor, is the PI on three studies, one along with Jared Radbel, MD, assistant professor, who also is a PI on an observational study; and Sugeet Jagpal, MD, assistant professor, is the site PI for a study of convalescent plasma as a treatment of patients with COVID-19.
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