Duke Clinical Research Institute

April 1, 2020 – The Patient-Centered Outcomes Research Institute has funded up to $50 million to evaluate hydroxychloroquine as a preventive drug for the novel coronavirus.

A new rapid-response study designed and led by the Duke Clinical Research Institute (DCRI) 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 this novel 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 approved up to $50 million to support 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. The study results will be shared widely with the healthcare community.

“Healthcare workers on the front lines are critical to the pandemic response. To address their needs, we need to do rapid-cycle research and clinical trials,” said the DCRI’s Adrian Hernandez, MD, MHS, Professor of Medicine in Cardiology, who initiated the program and is serving as the administrative principal investigator. “Although there has been discussion about hydroxychloroquine as a potential prevention for COVID-19, we are lacking the data on safety and efficacy of this therapy. 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 program 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, MD, and Russell Rothman, MD, co-chairs of the program’s steering committee. “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.”

Currier is Professor of Medicine and Chief of the Division of Infectious Diseases at UCLA Medical Center, Santa Monica. Rothman is Senior Vice President for Population and Public Health at Vanderbilt University Medical Center and Ingram Professor of Integrative and Population Health in the Vanderbilt University School of Medicine.

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, PhD, Assistant Professor in Duke’s Department of Population Health Sciences, and 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 trial, but will enable future trials as well, and seek to understand the wellbeing of healthcare workers on issues such as workforce stress, burnout, and other outcomes.

The second part, the randomized clinical trial HERO-HCQ, will be led by the DCRI’s Susanna Naggie, MD, Associate Professor of Medicine at Duke. The trial will launch later in April and will identify approximately 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 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  Susanna Naggie, MD workers, both for their safety and to prevent further spread of SARS-CoV-2 as they care for patients,” said Naggie. “Furthermore, 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 also oversee the study’s data coordinating center, with efforts led by Kevin Anstrom, PhD, Director of Biostatistics for the DCRI and a Professor of Biostatistics and Bioinformatics at Duke. The DCRI’s Frank Rockhold, PhD, Professor of Biostatistics and Bioinformatics at Duke, will lead the organization of and reporting for the Independent Data Safety Monitoring Board.

Hernandez, who initiated the HERO program, serves as Vice Dean for Clinical Research in the Duke University School of Medicine. Naggie, who is leading the HERO-HCQ trial, serves as Associate Dean for Clinical Research Initiatives and Regulatory Affairs.