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Trial to Test Malaria Drug to Stop Covid-19

Nurse at a Covid-19 drive-in testing site in New Jersey (Master Sgt. Matt Hecht, NationalGuard.mil)

2 Apr. 2020. A registry and clinical trial of health care workers aims to document effects of hydroxychloroquine, a widely available malaria drug, to prevent Covid-19 infections. The study is conducted by Duke University’s Clinical Research Institute, funded by a $50 million award from Patient-Centered Outcomes Research Institute, or PCORI.

The Healthcare Worker Exposure Response and Outcomes project aims to provide answers to continuing questions about the effectiveness of hydroxychloroquine to prevent Covid-19 infections that continue to climb in the U.S. and throughout the world. Hydroxychloroquine is an established anti-malarial drug, also used to treat the autoimmune disorders lupus and rheumatoid arthritis.

The Food and Drug Administration last week authorized use of hydroxychloroquine drugs from the U.S. strategic stockpile to treat adolescent and adult patients when clinical trials of other drugs are not available. And a small-sample trial in China shows effectiveness of the drug as a treatment for mild to moderate Covid-19 cases compared to a placebo.

The new test of hydroxychloroquine, on an accelerated timetable, will first recruit health care workers in the U.S. now treating Covid-19 patients and at high risk of infections, into a registry to provide a pool of participants for the trial. Registry members will be asked to give information about their work, current health, and psychological strain. The registry is also expected to support further studies of the health care workers’ well-being beyond the test of hydroxychloroquine.

Recruitment for the registry is set to begin in the next two weeks, with clinical trial enrollment taking place soon after that. The trial plans to recruit some 15,000 participants from the registry, where individuals will be randomly assigned to receive hydroxychloroquine or a placebo for one month, then monitored for two more months. The study team is looking for evidence of the drug’s safety and prevention of Covid-19 infections among health care workers, compared to the placebo, as well as limiting spread of the virus to others.

“Although there has been discussion about hydroxychloroquine as a potential prevention for Covid-19,” says Adrian Hernandez, vice-dean of clinical research and leader of the project in a Duke University statement, “we are lacking the data on safety and efficacy of this therapy. By conducting this study with health care workers, we are working directly with those who understand the importance of quickly getting answers into the hands of those on the front line.”

PCORI is a not-for-profit organization, authorized by Congress to carry out comparative effectiveness and other evidence-based research for health care decision-making. The organization is providing 40 sites from its established PCORnet network of 348 health care systems and 857,000 health care providers for the registry and clinical trial, as well as funding of up to $50 million for the project.

“For health care workers treating patients during this pandemic and beyond, prevention strategies are critical,” says PCORI interim executive director Josephine Briggs in an organization statement. “Using PCORnet to power this project will enable rapid data capture and analysis that will provide insights quickly to those who need it most.”

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