Vanderbilt University Medical Center is playing a key role in a national effort to establish a registry of U.S. health care workers and test whether the anti-malarial drug hydroxychloroquine (HCQ) will protect them, their patients and their families from COVID-19.
The Board of Governors of the non-profit Patient-Centered Outcomes Research Institute (PCORI) in Washington, D.C., today approved up to $50 million to fund the initiative, known as the Healthcare Worker Exposure Response and Outcomes (HERO) research program, to be led by the Duke Clinical Research Institute (DRCI).
Co-chairs of the HERO Steering Committee are Russell Rothman, MD, MPP, VUMC Senior Vice President for Population and Public Health, and Judith Currier, MD, professor of Medicine and chief of the Division of Infectious Diseases at UCLA Medical Center, Santa Monica.
Fellow steering committee member Sean Collins, MD, MSCI, professor and executive vice chair of the Department of Emergency Medicine at VUMC, will lead VUMC’s engagement in the HERO study and will serve as the site’s principal investigator. He also is a member of the protocol advisory committee.
Within the next two weeks the registry will begin to recruit tens of thousands of health care workers from across the country including doctors, nurses, respiratory therapists and paramedics, many of whom work on the frontlines of the coronavirus pandemic and are at high risk for COVID-19 infection.
About 15,000 of them will participate in the HERO-HCQ study, a randomized, placebo-controlled clinical trial that will begin later in April.
Leveraging the infrastructure of the National Patient-Centered Clinical Research Network (PCORnet) and its established research network of more than 850,000 clinicians and hundreds of health systems including VUMC, the study aims to answer two research questions.
Can HCQ prevent COVID-19 infection in health care workers who are exposed to the virus? Can the drug lower virus levels in those who have been infected but do not have symptoms so that they are less likely to transmit the infection to others?
“The HERO study offers an important opportunity for health care systems across the country to unite and use the national resources offered by PCORnet to answer some of the most critical questions facing our nation right now,” Rothman and Currier said in a news release.
“The urgency of the questions we are asking and the need for speed cannot be overstated and it’s heartening to see the dedication being poured into this effort,” they said.
Collins added: “This is the first study to evaluate a concern on all front-line health care workers’ minds: Am I bringing COVID-19 home to my family and friends and is there a way for me to prevent becoming ill? This study will provide important answers regarding asymptomatic disease and the ability of HCQ to prevent clinical infection.”
Also quoted in the PCORI announcement was Dawn Hawley, MSN, RN, an emergency department nurse at VUMC.
“It is important to study how we might be able to prevent this infection in our health care workers,” Hawley said. “By taking care of our health care teams, this allows us to better take care of our patients. Determining the best way to protect our staff shows compassion, which in turn we can show for our patients.”
DCRI’s Emily O’Brien, PhD, assistant professor of Population Health Sciences at Duke University, will lead the effort to build the registry. Susanna Naggie, MD, DCRI director of infectious diseases research and associate professor of Medicine, will head up the HERO-HCQ trial.
Study participants will be recruited at about 40 PCORnet sites across the country including VUMC and Williamson Medical Center. They will be randomly selected to receive HCQ or placebo for 30 days and then will be followed for two months.
“It’s important that we assess the effectiveness of this drug for prophylaxis treatment in health care workers, both for their safety and to prevent further spread of SARS-CoV-2 as they care for patients,” Naggie said in today’s announcements.
“PCORI is very pleased to fund this critical study as part of the effort to marshal the nation’s scientific and clinical expertise to address the unprecedented threat COVID-19 poses to the United States,” added PCORI Interim Executive Director Josephine Briggs, MD.
“This study’s focus on high-risk health care workers is especially important given their vital role on the frontlines of treating this novel infection,” Briggs said. “Using PCORnet to power this project will enable rapid data capture and analysis that will provide insights quickly to those who need it most.”
In addition to serving as a source of recruitment into the clinical trial, the registry will provide valuable information about the impact of COVID-19 on health care workers and their families including such issues as stress and burnout.
Rothman is the Ingram Professor of Integrative and Population Health and director of the Institute for Medicine and Public Health. He also is principal investigator of the PCORI-funded Stakeholders, Technology and Research (STAR) Clinical Research Network.
The STAR CRN encompasses VUMC, the Vanderbilt Health Affiliated Network, Meharry Medical College, Duke, the University of North Carolina at Chapel Hill, Wake Forest Baptist Health, Health Sciences of South Carolina and the Mayo Clinic in Minnesota.
PCORI is an independent organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions. For more information about PCORI’s funding, visit www.pcori.org.
