NEW BRUNSWICK – Rutgers University said Tuesday it’s launched the nation’s largest prospective study of health care workers exposed to COVID-19, including a series of clinical trials that will explore new drug treatments, antibody testing and long-term health tracking as to how to treat the disease and prevent its spread.

About 550 health care providers and about 300 non-health care workers from Rutgers, University Hospital in Newark, and Robert Wood Johnson University Hospital in New Brunswick have volunteered for the study, some having had direct patient exposure and others having had none, the university said in a statement.

READ: Rutgers Cancer Institute begins clinical trial for COVID-19 patients

All of the MyCentralJersey coverage of the coronavirus is being provided for free to our readers. Please consider supporting local journalism by subscribing to MyCentralJersey.com at MyCentralJersey.com/subscribe.

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, the university said. Some of this may be attributed to the existing disparity in the nursing workforce, which currently includes more women than men.

“Health care workers throughout the world are on the front lines of battling COVID-19,” RBHS Chancellor Brian Strom said in a statement. “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 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 U.S. Food and Drug Administration to begin the nation’s first saliva-based test for COVID-19. Middlesex County rolled out the saliva test last week at a drive-through site in Edison, and he test is also being conducted at all RWJBarnabas Health sites throughout the state, as well as University Hospital in Newark.

READ:Coronavirus: Middlesex County first in US to offer drive-thru saliva test

The study prospectively will 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, the university said.

Such information is critically important in determining who gets infected and their susceptibility characteristics for infection, said Dr. Martin J. Blaser, director of Rutgers University’s Center for Advanced Biotechnology and Medicine. Separately, the trial will also determine whether some health care workers will develop immunity and, thus, could be first responders in the pandemic, said Blaser, also a professor of medicine and microbiology at Rutgers Robert Wood Johnson Medical School.

"Susceptibility will be determined based on their exposures in the hospital – for example, the number, types and intensities of exposures," Blaser said. "In the future, working with colleagues, we hope to examine genetic susceptibility, looking at genes that might be especially relevant to COVID.

"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.”

“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,” added Reynold Panettieri Jr., director of the Rutgers Institute for Translational Medicine and Science and program director for New Jersey Alliance for Clinical and Translational Science, a statewide consortium of Rutgers, Princeton University and New Jersey Institute of Technology researchers.

Clinical trials

The university has sanctioned two clinical trials as part of the study.

The first was launched two weeks ago 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 that will determine if azithromycin combined with hydroxychloroquine is better than hydroxychloroquine alone for treatment of patients with COVID-19.

Azithromycin is approved by the 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.

READ:Coronavirus: Rutgers medical students mobilize to support pandemic battle

There is no standard antiviral therapy approved by the FDA for the treatment of people with COVID-19.

“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," Rutgers Cancer Institute Director Dr. Steven Libutti said. "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."

The endpoint of the study is the efficacy of hydroxychloroquine and azithromycin on reducing viral load, Libutti said.

Viral load quantification has not yet been performed and analyzed as per the protocol, he said.

"We have not seen any serious side effects attributable to the study agents as of yet," Libutti said.

The second clinical trial, led by week's end or the beginning of next by Jeffrey Carson, a provost at RBHS, will focus on those who test positive for COVID-19 but are asymptomatic, Blaser said.

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, Blaser said.

"In many ways, it's safest to study people with no symptoms to see if the treatment is protective against developing severe illness," he said.

This study also will determine whether prophylaxis with these drugs prevent symptom development, Blaser said.

The trials will be offered at Rutgers Cancer Institute, Robert Wood Johnson University Hospital and University Hospital and are not limited to cancer patients. These studies are supported by the National Cancer Institute, National Center for Advancing Translational Science, corporate partners Marken/UPS and dfYoung and individual philanthropic support, according to the university.

For information on how to take part in the Rutgers Cancer Institute clinical trial, call Rutgers Cancer Institute’s Office of Human Research Services at 732-235-7356 or email statewide_research@cinj.rutgers.edu.

Email: bmakin@gannettnj.com

Bob Makin covers Rutgers for MyCentralJersey.com and the USA TODAY NETWORK New Jersey. To get unlimited access to his informative and entertaining work, please subscribe or activate your digital account today.