WASHINGTON (April 1, 2020) - The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today approved up to $50 million to fund a registry and randomized clinical trial of the effectiveness of hydroxychloroquine (HCQ) in preventing COVID-19 infections in U.S. healthcare workers.
The registry will create a community of healthcare workers (HCWs) interested in contributing to understanding the impact of COVID-19 on them and their colleagues, families and friends, and to determine their willingness to participate in clinical studies. The trial will evaluate the use of HCQ in addition to usual practice in both preventing COVID-19 infection in exposed healthcare workers and limiting the amount of virus HCWs without symptoms might spread and thus unintentionally disperse to others.
The study, led by the Duke Clinical Research Institute (DCRI), 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 healthcare community, including participating healthcare workers and others most affected.
"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 PCORI Interim Executive Director Josephine P. Briggs, MD. "This study's focus on high-risk healthcare workers is especially important given their vital role on the front lines of treating this novel infection."
"For healthcare 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."
The newly funded initiative, known as the Healthcare Worker Exposure Response and Outcomes (HERO) research program, will have two components. The first, the registry, will engage HCWs so researchers can understand their physical and emotional health status or gauge interest in addressing the COVID-19 pandemic or facilitate their enrollment into future studies. The second component is the HERO-HCQ trial, which will identify about 15,000 registry participants for inclusion in a randomized, placebo-controlled trial that will examine whether taking HCQ for one month is effective in both preventing COVID-19 infection in exposed healthcare workers and holding down the amount of virus HCWs without symptoms might unintentionally spread to others.
The registry is expected to launch in early April, with nationwide enrollment of healthcare workers. The randomized clinical trial will involve about 40 PCORnet sites across the United States and is expected to start later in April. Enrolled healthcare workers will receive either HCQ or a placebo for 30 days and then be followed for two months.
Using PCORnet to conduct the study offers several major advantages over traditional trials. The network has a wealth of information to draw on in setting up the trial registry. It also has a well-established community of healthcare systems with experience collaborating on large clinical studies engaging patients and clinicians alike. This community will facilitate the oversight essential to ensure the study is carried out ethically and allow any interested healthcare or emergency worker to easily join the study. And once the registry is established, it can serve as a community to efficiently conduct future trials, including those involving participants beyond the healthcare community.
"It is important to study how we might be able to prevent this infection in our healthcare workers," said Dawn Hawley, RN, MSN, an emergency department nurse at Vanderbilt University Medical Center. "By taking care of our healthcare 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."
The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit 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. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work.