A new research program to understand the effect of COVID-19 on health care workers is soon to be underway at University of Florida Health and other sites across the country. A clinical trial to evaluate whether hydroxychloroquine can prevent COVID-19 infections is also being planned.
The Healthcare Worker Exposure and Outcomes, or HERO, initiative has two parts — a registry and a clinical trial. The registry, which comes out of Duke University, hopes to enroll hundreds of thousands of health care workers nationally who are at risk of developing the COVID-19 infection. Registry members will then be eligible for a clinical trial of hydroxychloroquine’s effectiveness in preventing COVID-19 infection in health care workers, called the HERO-HCQ trial.
At UF Health, a group of researchers and staff will help to recruit health care workers for the Duke registry. Then, up to 1,125 people may ultimately participate in the HERO-HCQ clinical trial through UF Health — 375 each in Gainesville, Jacksonville and Leesburg.
The HERO program is a special opportunity to learn how COVID-19 affects health care workers and to potentially study hydroxychloroquine’s effectiveness as a preventive measure, said Elizabeth A. Shenkman, Ph.D., a professor and chair of the UF College of Medicine’s department of health outcomes and biomedical informatics. She is also the principal investigator for the OneFlorida Clinical Research Consortium, which includes the HERO sites in Florida.
Anyone who works in health care — at UF Health or elsewhere — can join the registry. Researchers are aiming to enroll physicians, nurses, food service workers, respiratory therapists, environmental services workers and others. Those who join the registry will have the option of providing health information about relevant COVID-19 risk factors, medical encounters and health status to the database at Duke.
“We want a truly diverse group of workers with different types of health care jobs in various locations. The idea is to allow them to respond to questions about their exposures to COVID-19 and any resulting stresses or conditions,” Shenkman said.
The registry is like a time capsule that will capture the experiences of many health care workers on the frontlines of the COVID-19 pandemic, said Lisa H. Merck, M.D., an associate professor and vice chair of research in the College of Medicine’s department of emergency medicine. As a clinical site principal investigator for the HERO-HCQ project, she is overseeing the study’s execution at UF Health. Merck said she would like to have as many essential UF Health workers as possible join the registry.
“This is a cohort study that none of us anticipated being participants of. However, we are all on the frontlines together. This registry will reflect our experiences, over time, as health care workers, whether we are in environmental services, respiratory therapy, or aboard (UF Health) ShandsCair helicopters. The registry is a phenomenal opportunity to capture the diverse experiences of health care workers across the nation,” she said.
OneFlorida sites participating in the HERO registry include UF Health in Gainesville, Jacksonville and Leesburg, the University of South Florida, Tampa General Hospital, AdventHealth, Tallahassee Memorial Healthcare and the University of Miami Health System. UF Health in Gainesville, Jacksonville and Leesburg as well as the University of South Florida, Tampa General Hospital and AdventHealth are also among some 40 locations nationwide participating in the hydroxychloroquine clinical trial. Visit the HERO research website to learn more or join the registry.
“This study is crucial for many reasons, most of all because it will provide much-needed evidence about whether hydroxychloroquine can protect our health care workers at the frontlines of this fight from COVID-19 ,” said Alexander Parker, Ph.D., senior associate dean for research at the UF College of Medicine – Jacksonville. “Our team is proud to partner with our colleagues in Gainesville and institutions around the country to find answers to this crisis as quickly as possible.“
Hydroxychloroquine has been widely discussed as a potential therapeutic for COVID-19. It is approved by the U.S. Food and Drug Administration to treat malaria, lupus and rheumatoid arthritis. Once final approval is provided by the FDA and local administration, the clinical trial will be scheduled to enroll participants. Subjects who meet eligibility criteria will be randomly assigned to take hydroxychloroquine or a placebo for one month. In addition to evaluating the drug’s benefits and risks, the study also will explore how well the drug can prevent health care workers from unintentionally spreading the virus to members of their families.
“It is hard to think that by doing my daily job, not only can I get sick, but I can infect those who I love the most,” said Jorge Lascano, M.D., an associate professor of pulmonary and critical care in the UF College of Medicine’s department of medicine. “This is the time to be proactive, to develop ways to stay safe on the front lines. I encourage everyone to be a part of HERO — and part of the solution.”
The researchers hope to begin enrollment for the clinical trial by the end of April. Once the final protocol is received, approval to conduct clinical trial work at UF Health will be provided by the UF Institutional Review Board, a group of UF faculty and community members who review and approve all research for human subjects conducted at UF.
The HERO initiative is being led by the Duke Clinical Research Institute, part of the Duke University School of Medicine. Funding of up to $50 million is being provided by the Patient-Centered Outcomes Research Institute (PCORI), a Washington, D.C.-based independent, nonprofit organization. Its mission is to fund research that provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions.