The National Institutes of Health (NIH) confirmed on Tuesday that the first U.S. clinical trial for a coronavirus treatment has launched at the University of Nebraska Medical Center (UNMC) in Omaha, Nebraska. The experimental therapy is biotech giant Gilead’s remdesivir, an antiviral with the potential to treat a host of pathogens—including COVID-19, the disease caused by the new, novel coronavirus strain.
The treatment could hold real promise as coronavirus infections and deaths outside of China continue to swell. “There is only one drug right now that we think may have real efficacy and that’s remdesivir,” said WHO assistant director-general Bruce Aylward during a press conference in Beijing on Monday. The drug is already being enlisted in clinical trials in China.
The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) will be the trial’s regulatory sponsor. While remdesivir is already being tested in other countries (and has previously been tested in other forms of coronavirus, including MERS and SARS) this will be the first time that a so-called “gold standard” trial of the treatment will be tested in America.
“A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients,” said NIAID director and U.S. Coronavirus Task Force member Anthony Fauci in a statement. Similar double-blinded trials are ongoing in China.
A double-blinded, randomized trial means that neither the patients receiving an experimental therapy nor the clinicians administering the drug will know whether someone is receiving the actual treatment or a placebo. The first U.S. patient to enroll in the trial is, according to the NIH, an American who volunteered for the study. The individual was one of the thousands of people quarantined on the Diamond Princess cruise ship in Japan before being repatriated to the U.S.
Gilead’s treatment, unlike many of the other drugs being developed in the outbreak’s wake, isn’t a vaccine. It’s meant to treat those who have already been infected by the new coronavirus strain and have contracted the respiratory ailment COVID-19.
Gilead stock rose nearly 7% on Monday following the WHO’s statement of confidence, though it’s fallen about 4% on Tuesday in what may be a correction.
To date, there have been close 2,100 coronavirus-related deaths in China and nearly two dozen in other nations. In the U.S., there have been 53 confirmed cases among residents and those who have been repatriated to America, according to the CDC.
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