DURHAM – Duke University’s Clinical Research Institute is launching a study to determine whether the drug hydroxychloroquine can be used to prevent COVID-19 infections among healthcare workers. And the institute can draw upon as much as $50 million for the program with funding provided by the Patient-Centered Outcomes Research Institute.
The DCRI announced the initiative on Wednesday, calling it a “rapid-response study.”
Hydroxychloroquine has been touted as a possible treatment for the coronavirus. It is a malaria drug.
The Patient-Centered Outcomes Research Institute has funded up to $50 million to evaluate hydroxychloroquine as a preventive drug for the novel coronavirus.
“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, who will serve as 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 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, 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.