NIH opens Phase II coronavirus trial with Gilead drug at University of Nebraska

The randomized, placebo-controlled study of Gilead’s remdesivir has been posted online and has enrolled the first patient, one of the passengers on a quarantined cruise ship docked off of Yokohama, Japan, who was repatriated to the U.S.

The cruise ship Diamond Princess, quarantined at a pier in Yokohama, Japan

A U.S. citizen who was repatriated from a cruise ship docked in Japan is the first participant in a National Institutes of Health clinical trial testing a Gilead Sciences drug as a treatment for coronavirus.

The NIH said it had initiated a trial of Gilead’s remdesivir for treating COVID-19 at the University of Nebraska Medical Center in Omaha, sponsored by the National Institute of Allergy and Infectious Diseases. The trial is a randomized, placebo-controlled Phase II study with an enrollment target of 394 patients.

COVID-19 is the name of the disease caused by the virus, now known as SARS-CoV-2, which was first detected in December in Wuhan, China.

The first patient in the Nebraska trial is one of 40 infected Americans who were passengers on the cruise ship Diamond Princess, which was docked off of Yokohama, Japan, as part of a quarantine of the more than 300 American passengers on board. However, while the Department of State had wanted the infected passengers to be repatriated, the Centers for Disease Control and Prevention had recommended against it.

Thirteen people whom the Department of State had repatriated from the Diamond Princess have been transported to the National Quarantine Unit at the UNMC campus.

Remdesivir was originally developed as a treatment for the Ebola virus, but it has also shown broad-spectrum efficacy against epidemic and zoonotic coronaviruses in mouse models, including against the SARS and MERS coronaviruses. Following a Jan. 31 report in The New England Journal of Medicine that a 35-year-old man in Washington state who was infected had seen improvement in symptoms after taking remdesivir, it was reported that hospitals in Wuhan were also testing the drug.

“We urgently need a safe and effective treatment for COVID-19,” NIAID Director Anthony Fauci said in a statement. “Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes.”

Other companies developing drugs and vaccines against SARS-CoV-2 include Moderna, which on Monday shipped the first batch of a vaccine it is developing against the virus for a clinical trial that the NIAID is also running. Johnson & Johnson, Sanofi and Regeneron Pharmaceuticals are partnered with the government in developing products of their own as well.

The total number of people infected globally now exceeds 80,000, according to the World Health Organization, and 2,700 have died. The vast majority of infected people and deaths have been in China, though new outbreaks in South Korea, Iran and Italy have led to fears of a global pandemic. However, the WHO has not yet declared one.

Photo: Kazuhiro Nogi, AFP, via Getty Images