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Duke Raleigh Hospital Joins National Clinical Trial

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Duke Raleigh Hospital is now participating in the second phase of a national study to investigate a therapy to treat symptoms of COVID-19.

Patients with significant symptoms of COVID-19 will be given the option to participate in the trial, which has already begun at Duke Raleigh Hospital. Those patients who choose to participate in the trial will be given the antiviral drug remdesivir, which has shown an improvement in the recovery time of more than 1,000 hospitalized patients from 15 days to 11 days. Remdesivir was cleared for emergency use by the FDA last week.

As a result, Duke Raleigh Hospital is helping to test if remdesivir could continue to improve COVID-19 symptoms when paired with another drug, baricitinib, usually used to treat inflammation associated with moderate-to-severe arthritis.

“The quicker we can find effective treatments to help our patients and the larger medical community, the quicker we can gain control of this disease,” said Dr. Michael Spiritos, chief medical officer, Duke Raleigh Hospital. “Here we have the opportunity to advance the understanding of this disease for everybody.”

Participants in this next phase of the study will receive a daily intravenous dosage of remdesivir for 10 days, followed by either baricitinib or a placebo of inactive ingredients, as tablets once daily while they are hospitalized for a period no longer than 14 days. Patients will be assessed daily for measurable changes in their conditions.

This is an adaptive randomized, double-blind trial that assigns patients at random to receive either remdesivir and baricitinib or remdesivir plus the placebo. Doctors and patients do not know who is getting both active therapies.

The study is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), and managed by the Frederick National Laboratory for Cancer Research. Gilead Sciences Inc. developed remdesivir and is supplying it for the study.

“We are delighted to have the opportunity to work alongside our colleagues within the Duke University Health System to bring this study to Duke in Wake County to inspire hope for some of our sickest COVID-19 patients,” said Dr. David Zaas, president, Duke Raleigh Hospital.

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