Pharmaceutical & Life Sciences News

Trump-Touted Virus Drug Ready for Trial in Health Workers (1)

April 1, 2020, 7:38 PMUpdated: April 1, 2020, 8:03 PM

The drug President Donald Trump has promoted as a Covid-19 treatment will be put to the test this month in a clinical trial studying how well it protects health-care workers.

The Duke Clinical Research Institute will lead the study and start by building a registry of health-care workers around the country, according to the Patient-Centered Outcomes Research Institute, which is providing up to $50 million for the research.

Clinicians will use that registry to recruit 15,000 people across 40 sites nationwide to participate in a randomized, placebo-controlled trial set to begin later this month to test the effectiveness of hydroxychloroquine, which treats malaria, lupus, and rheumatoid arthritis.

Trump has said hydroxychloroquine shows “tremendous promise” against the new coronavirus. Other health experts like Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, have been more cautious, emphasizing the need for further study.

Demand for the drug has surged since Trump put it in the spotlight. The Food and Drug Administration officially placed hydroxychloroquine on the drug shortage list Tuesday, following reports of hoarding and patients using it to prevent Covid-19.

As part of the trial, health-care workers will take either hydroxychloroquine or a placebo for 30 days. They’ll be followed for two months to test whether the drug prevents Covid-19 in people exposed to the virus and if it stunts the spread of coronavirus in those not yet showing symptoms.

“This study’s focus on high-risk healthcare workers is especially important given their vital role on the front lines of treating this novel infection,” Josephine P. Briggs, interim executive director of the Patient-Centered Outcomes Research Institute, said in a statement Wednesday.

The University of Minnesota March 17 launched a separate clinical trial that tests whether the malaria drug can prevent the progression of Covid-19 and hospitalizations. That trial is open to health-care workers and people with a known diagnosis or exposure to a known case.

(Updated with information about separate clinical trial in eighth paragraph )

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com

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