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Duke to spearhead $50 million research effort to test hydroxychloroquine in preventing COVID-19

Up to $50 million has been approved for new research on a potential COVID-19 treatment, and Duke is taking charge.

The Patient-Centered Outcomes Research Institute, a federal government-sponsored nonprofit that funds studies across a variety of types of research, announced a new program April 1 to research hydroxychloroquine, most commonly used as an anti-malaria drug, as a way to prevent COVID-19 infections for high-risk healthcare workers. The program will be led by a Duke research team at the Duke Clinical Research Institute, which is part of the School of Medicine.

This newly launched program, called Healthcare Worker Exposure Response and Outcomes—or HERO—has up to $50 million in funding and will also bring in PCORI's network of health systems and healthcare workers across the country.

Hydroxychloroquine, which was recently touted by President Donald Trump as a potential coronavirus treatment, was approved by the FDA Sunday to treat COVID-19 in emergency situations. Alex Azar, U.S. secretary of health and human services, suggested that the drug is one of "multiple potential therapeutics" for COVID-19 on Twitter.

Hydroxychloroquine has limited clinical evidence but significant promise after doctors in China reported that the drug may help alleviate symptoms in coronavirus-positive people.

Unlike in that study, the new Duke-led one will look at using the drug to prevent COVID-19 for healthcare workers and prevent new spread of the virus. While clinical trials for new disease treatments are usually lengthy processes, the new study is aiming for speed as well as success.

“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," the study's co-chairs—Judith Currier, chief of the division of infectious diseases at the University of California, Los Angeles, and Russell Rothman, professor of internal medicine, pediatrics and health policy at Vanderbilt University Medical Center and—said in a news release

Rothman, Trinity ‘92, MPP ‘96 and School of Medicine ‘96, is also senior vice president for population and public health at VUMC.

Adrian Hernandez, vice dean for clinical research in the Duke School of Medicine, started Duke's hydroxychloroquine research program and is leading the new study as the principal investigator.

“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,” Hernandez said in the news release.

However, before the program yields results, it will consist of two parts. First, Duke researchers led by Emily O'Brien, assistant professor in population health sciences, will create a national registry of healthcare workers who are at high risk of COVID-19. By April, the team hopes to move to the second part of the program, when 15,000 healthcare workers will receive either hydroxychloroquine or a placebo for a month.

Researchers will then look at the benefits and potential risks and side effects of using the drug more widely. It is unclear when results of the study will be released.

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