The nation’s largest prospective study of health care workers exposed to COVID-19 includes a series of clinical trials that will explore new drug treatments, antibody testing, and long-term health tracking.
Close to 550 health care providers and close to 300 non-health care workers from Rutgers University, 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.
Initial results suggest a gender disparity in risk: women have been infected at a rate of 13 times their male counterparts. Researchers attribute some of this to the existing disparity in the nursing workforce, which currently includes more women than men.
“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.”
“Health care workers throughout the world are on the front lines of battling COVID-19,” says Brian Strom, chancellor of Rutgers Biomedical and Health Sciences (RBHS). “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.”
Those who participate in the study will receive tests for COVID-19 at Rutgers’ RUCDR Infinite Biologics, which last week received emergency use authorization from the Food and Drug Administration (FDA) 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,” says Martin J. Blaser, director of the 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,” says Reynold Panettieri Jr., director of the 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. Researchers enrolled them in a clinical trial at Rutgers Cancer Institute of New Jersey to determine if azithromycin combined with hydroxychloroquine works better than hydroxychloroquine alone for treatment of patients with COVID-19.
The FDA has approved azithromycin for the treatment of infections and hydroxychloroquine for the treatment of malaria and autoimmune diseases, such as lupus and rheumatoid arthritis.
The FDA has not approved a standard antiviral therapy 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,” says Steven Libutti, the director of the Rutgers Cancer Institute who is also senior vice president in oncology services at RWJBarnabas Health and vice chancellor of cancer programs at 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 decrease faster with hydroxychloroquine or with the combination of hydroxychloroquine and azithromycin. This study will also determine whether prophylaxis with these drugs prevent symptom development.
For information on how to take part in the Rutgers Cancer Institute clinical trial, individuals should call Rutgers Cancer Institute’s Office of Human Research Services at 732-235-7356 or email firstname.lastname@example.org.
Support for these studies comes from 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