Rutgers University announced today that it has launched the nation’s largest prospective study of health care workers exposed to COVID-19. The study includes a series of clinical trials that will explore new drug treatments, antibody testing, and long-term health tracking in the hope of providing insight into how to treat the disease and prevent its spread.
Close to 550 healthcare providers and close to 300 non-healthcare workers from Rutgers, University Hospital in Newark, and Robert Wood Johnson University Hospital in New Brunswick have volunteered for the study, some with direct patient exposure and others with no direct patient contact. The study is being coordinated by Rutgers Biomedical and Health Sciences (RBHS), the university’s academic health center. Initial results suggest a gender disparity in risk: women have been infected at a rate of 13 times their male counterparts. Some of this may be attributed to the existing disparity in the nursing workforce, which currently includes more women than men.
“Healthcare workers throughout the world are on the frontlines of battling COVID-19,” said RBHS chancellor Brian Strom. “Our hope is that this study and other scientific developments can give state, national, and global leaders the evidence-based tools to ultimately end this pandemic.”
Rutgers employs more than 7,000 doctors, nurses, and health professionals throughout the state of New Jersey. Those who participate in the study will be tested for COVID-19. Testing will be carried out at Rutgers’ RUCDR Infinite Biologics, which last week received emergency use authorization from the Food and Drug Administration to begin the nation’s first saliva-based test for COVID-19.
The study will prospectively determine infection rates in the Rutgers workforce who regularly treat patients and for those without direct patient exposure by following the participants for six months. The point of the study is to determine the proportion of the workforce who will get infected. Such information is critically important in determining who gets infected and their susceptibility characteristics for infection. Separately, the trial will also determine whether some health care workers will develop immunity and, thus, could be first responders in the pandemic.
“Because the pandemic is affecting our hospitals as we are providing care at the front-line, we may be able to discover what puts people at greatest risk for acquiring the infection and possibly determine why most get mild illness but some become severely ill,” said Martin J. Blaser, director of Rutgers University’s Center for Advanced Biotechnology and Medicine and professor of medicine and microbiology at Rutgers Robert Wood Johnson Medical School.
“Collectively, our studies will provide a wealth of data designed to better arm the health care workforce to minimize self-risk while improving care to Americans in this pandemic crisis,” said Reynold Panettieri Jr., director of the Rutgers Institute for Translational Medicine and Science and the program director for the New Jersey Alliance for Clinical and Translational Science, a statewide consortium of Rutgers, Princeton University and New Jersey Institute of Technology researchers.
The university has launched two clinical trials as part of the study. The first is for patients who test positive for COVID-19 and are symptomatic. They have been enrolled in a clinical trial at Rutgers Cancer Institute of New Jersey. The trial will determine if azithromycin combined with hydroxychloroquine is better than hydroxychloroquine alone for treatment of patients with COVID-19. Azithromycin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of infections. Hydroxychloroquine is approved by the FDA for the treatment of malaria and autoimmune diseases, such as lupus and rheumatoid arthritis.
There is no standard antiviral therapy approved by the FDA for the treatment of people with COVID-19. At present, clinical management includes infection prevention, control measures and supportive care.
“While some practitioners across the state have been offering this type of treatment for some individualized cases, it is imperative that a controlled clinical trial with a large patient population take place in order to ensure the integrity of the results being gathered. As a National Cancer Institute-designated Comprehensive Cancer Center, Rutgers Cancer Institute of New Jersey has the infrastructure and expertise to carry out this clinical trial,” said Rutgers Cancer Institute director Steven Libutti, MD, FACS, who is also senior vice president, oncology services, RWJBarnabas Health, and vice chancellor, cancer programs, Rutgers Biomedical and Health Sciences. The second clinical trial, led by Jeffrey Carson, a provost at RBHS, will focus on those who test positive for COVID-19 but are asymptomatic. This will be a carefully controlled clinical trial to determine whether the viral infection can be decreased faster with hydroxychloroquine or with the combination of hydroxychloroquine and azithromycin. This study will also determine whether prophylaxis with these drugs prevent symptom development.
The trials, which will be offered at Rutgers Cancer Institute, Robert Wood Johnson University Hospital in New Brunswick, and University Hospital in Newark, and are not limited to cancer patients. These studies are supported by the National Cancer Institute, National Center for Advancing Translational Science, corporate partners such Marken/UPS and dfYoung, as well as individual philanthropic support.
Source: Rutgers University