The University of Kansas Medical Center announced today that it will be participating in a nationwide clinical trial to evaluate the effectiveness of hydroxychloroquine (HCQ) in preventing COVID-19 infection in exposed health care workers. KU Medical Center is one of 60 such sites across the nation that will be participating in this clinical trial, led by the Duke Clinical Research Institute.
The trial, the Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO HCQ), will launch April 22. It is a phase-3 double-blinded clinical trial, funded by the Patient-Centered Outcomes Research Institute (PCORI). It is accompanied by a registry, launching today, that will create a community of health care workers who have expressed interest in contributing to the scientific community’s understanding of the impact of COVID-19.
Mario Castro, M.D., MPH, vice chair for clinical and translational research and pulmonologist at the University of Kansas School of Medicine, will serve as principal investigator for the KU Medical Center site of the study.
“At this point in the pandemic, hospitals are reporting that 20% of U.S. health care workers are becoming infected with COVID-19. When that happens, one in five must go into quarantine and cannot take care of patients,” Castro said. “This study is critical for safeguarding the personal health of these workers and for protecting the health care workforce at this critical time. Our hope is that this drug will decrease the risk of exposed workers developing an active COVID-19 infection.”
KU Medical Center aims to recruit 500 participants to the study while also promoting the registry, which will enroll health care workers from throughout the United States, at heroesresearch.org. The HERO Registry is open to all health care workers in the United States, including nurses, therapists, physicians, emergency responders, food service workers and environmental service workers – anyone who works in a setting where people receive health care and are exposed to COVID-19.
The plan is to use the registry to locate health care workers for the current drug trial, but the registry also will allow health care workers to indicate their willingness to participate in future clinical trials regarding COVID-19.
“Health care workers on the front lines are critical to the pandemic response,” said Adrian Hernandez, M.D., a Duke professor of cardiology and the administrative principal investigator of the nationwide trial. “To address their needs, we need to do rapid-cycle research and clinical trials,” said Hernandez, who originated the program and is a member of the Duke Clinical Research Institute.
“Although there has been discussion about hydroxychloroquine (HCQ) as a potential prevention method for COVID-19, we are lacking the data on safety and efficacy of this therapy,” Hernandez said. “By conducting this study with health care workers, we are working directly with those who understand the importance of quickly getting answers into the hands of those on the front line.”
Marshaling a strong response
The study and the registry are funded by an award from PCORI, a nonprofit organization established in 2010 through the Patient Protection and Affordable Care Act. Congress re-authorized funding of PCORI in December 2019.
“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,” said Josephine P. Briggs, M.D., PCORI interim executive director. “This study’s focus on high-risk health care workers is especially important given their vital role on the front lines of treating this novel infection.”
The study will leverage the infrastructure of PCORnet, the National Patient-Centered Clinical Research Network, and its established research network of more than 850,000 clinicians and hundreds of health systems, to allow research to be conducted quickly and efficiently. Study results will be shared widely with the health care community, including participating health care workers and others most affected. KU Medical Center is a member of PCORnet.
“For health care workers treating patients during this pandemic and beyond, prevention strategies are critical,” Briggs said. “But we need more data and evidence about HCQ’s safety and effectiveness. Using PCORnet to power this project will enable rapid data capture and analysis that will provide insights quickly to those who need it most.”
Russ Waitman, Ph.D., director of medical informatics at the KU Medical Center, is the principal investigator of the PCORnet Greater Plains Collaborative Clinical Data Research Network, which includes 12 medical centers in nine states.
Health care workers interested in participating in the hydroxychloroquine clinical trial at KU Medical Center may contact Shelby Almo at [email protected] or 913-574-3006, and they also must register at heroesresearch.org. Health care workers interested in learning more or in participating in the registry should visit the website at heroesresearch.org.