Duke patients with significant symptoms of COVID-19 will be given the option to participate in the trial, which will begin immediately and be limited to adults.The treatment, known as remdesivir, is an antiviral agent previously tested in humans with Ebola virus disease.
According to an announcement from Duke on Wednesday morning, remdesivir has shown promise in animal studies against MERS and SARS, diseases that emerged from different types of coronavirus, the virus that causes COVID-19.
The study will evaluate the safety and effectiveness of the drug in treating COVID-19.
“Duke’s participation in this national study creates an extra option for potential patients in our community who have serious complications from COVID-19,” Dr. Cameron Wolfe, the study’s principal investigator, said in a written statement. “Currently, there are no approved therapies for this disease, so we are eager to contribute in any way to help find ways to fight this global pandemic.”
Wolfe said remdesivir works by directly attacking the virus, by preventing it from reproducing. He said the study is unusual in that it is designed to incorporate information developed at other research centers or in other countries as the pandemic unfolds, which could point to potential changes in dosages or perhaps the addition of another drug.
The testing is also unusual in the time it took to put together. Because of the urgency surrounding coronavirus, a clinical trial that normally would have taken months to begin was organized at Duke in six days, Wolfe said.
As with other clinical trials, some patients who agree to participate will be given remdesivir and others will be given a mock treatment or placebo. The patients who receive the drug will be chosen at random, and neither they nor their doctors will know.
The trial will be limited to patients with serious symptoms, such as breathing difficulties that require supplemental oxygen or a ventilator.
“The trial is limited to people in the hospital with more severe symptoms, because most people with COVID-19 will recover fine at home with no need for therapies,” Dr. Emmanuel “Chip” Walter, co-investigator on the study, said in a written statement. “We do not want to expose people with mild or no symptoms to a therapy that could have potential side effects.”
As of Wednesday morning, Duke University Hospital did not have any admitted COVID-19 patients, but Wolfe said that’s expected to change.
“I think we’re about to face our first wave of patients,” he said. “We think we’ve got this available at a time that’s the right time.”
The study is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), and is managed by the Frederick National Laboratory for Cancer Research in Maryland. Gilead Sciences, the company that developed remdesivir, is supplying the drug for the study.
Duke is one of more than a dozen places taking part in the clinical trial; others include large university medical centers in Colorado, Minnesota and Massachusetts. The trial began at the University of Nebraska Medical Center in late February.
Wolfe said Duke was chosen in part because of its work in previous research.
“Duke does a lot of NIH research already,” he said. “To some extent, we were a known quantity.”
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