DURHAM, N.C. -- The Patient-Centered Outcomes Research Institute has funded up to $50 million to evaluate hydroxychloroquine (HCQ) as a preventive drug for the novel coronavirus.
The funding creates a new rapid-response study designed and led by the Duke Clinical Research Institute (DCRI) which seeks to engage healthcare workers across the nation to understand the impact of COVID-19 on their health and to evaluate whether hydroxychloroquine can prevent COVID-19 infections in healthcare workers at high risk of contracting the coronavirus.
The launch of the Healthcare Worker Exposure Response and Outcomes (HERO) research program was announced today by the Patient-Centered Outcomes Research Institute (PCORI), whose Board of Governors today approved support for the program. The program will engage the powerful PCORI-funded PCORnet®, the National Patient-Centered Clinical Research Network, which is an established health research network involving more than 850,000 clinicians and hundreds of health systems across the U.S. Study results will be shared widely with the healthcare community.
"Healthcare workers on the front lines are critical to the pandemic response," said Adrian Hernandez, M.D., a Duke professor of cardiology and member of the DCRI. "To address their needs, we need to do rapid-cycle research and clinical trials," said Hernandez, who originated the program and is serving as the administrative principal investigator.
"Although there has been discussion about hydroxycholoroquine (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 healthcare workers, we are working directly with those who understand the importance of quickly getting answers into the hands of those on the front line."
"The HERO study offers an important opportunity for healthcare 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," said Judith Currier, M.D., a co-chair of the study's steering committee and chief of infectious diseases at UCLA Medical Center, Santa Monica.
"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," said study co-chair Russell Rothman, M.D., senior vice president for population and public health and Ingram professor of integrative and population health at Vanderbilt University.
The HERO program will initially consist of two parts, a national registry and a randomized clinical trial.
The registry will be led by the DCRI's Emily O'Brien, Ph.D., an assistant professor in Duke's department of population health sciences. This effort will seek to rapidly identify and enroll a large community of healthcare workers at high risk for COVID-19 infection. Recruitment for the registry is expected to begin within the next two weeks. The registry will not only support recruitment into the clinical trial, it will also assess the wellbeing of healthcare workers on issues such as workforce stress, burnout and other outcomes, and enable future trials.
The randomized clinical trial, HERO-HCQ, will be led by the DCRI's Susanna Naggie, M.D., an associate professor of medicine at Duke. This trial will launch later in April, having identified about 15,000 healthcare workers from the registry to participate. The trial will randomize participants to either one month of hydroxychloroquine or one month of placebo and then will examine whether hydroxychloroquine is effective in decreasing the rate of COVID-19 infection.
In addition to the benefits and risks of using hydroxychloroquine, the study also will explore how well the drug can prevent healthcare workers from unintentionally spreading the virus to others.
"It's important that we assess the effectiveness of this drug for prophylaxis treatment in healthcare workers, both for their safety and to prevent further spread of SARS-CoV-2 as they care for patients," Naggie said. "The HERO registry of healthcare workers will ease study start-up times for future clinical trials that may be carried out for other prevention or treatment strategies."
The DCRI will oversee the study's data coordinating center, with efforts led by Kevin Anstrom, Ph.D., director of biostatistics for the DCRI and a professor of biostatistics and bioinformatics. The DCRI's Frank Rockhold, Ph.D., professor of biostatistics and bioinformatics, will be part of the data coordinating center and will lead the data safety monitoring board.
Adrian Hernandez serves as vice dean for clinical research in the Duke University School of Medicine. Susanna Naggie serves as Associate Dean for Clinical Research Initiatives and Regulatory Affairs.
About the Duke Clinical Research Institute
The DCRI, part of the Duke University School of Medicine, is the largest academic clinical research organization in the world. Its mission is to develop and share knowledge that improves the care of patients through innovative research. The institute conducts groundbreaking multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI also is home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making 40 years after its founding.