First US coronavirus trial launched into Gilead’s remdesivir

pharmafile | February 26, 2020 | News story | Research and Development FDA, Gilead, US, coronavirus, pharma 

The first US clinical trial investigating a treatment for the COVID-19 coronavirus has been launched by the US National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH).

The trial, which is being conducted at the University of Nebraska Medical Center (UNMC), will evaluate the efficacy and safety of Gilead’s antiviral therapy remdesivir in adult patients hospitalised with the coronavirus. The drug has been previously tested for Ebola virus disease and has shown efficacy in animal models for other coronaviruses, including severe acute respiratory sundrome (SARS) and Middle East respiratory syndrome (MERS). There are currently no treatments for the disease authorised by the FDA in the US.

The drug is also being evaluated in China, where the coronavirus originated in the city of Wuhan. The virus manifests as mild to severe respiratory disease and is characterised by flu-like symptoms such as fever, cough of shortness of breath.

There have been 77,262 confirmed cases and 2,595 deaths in China as of 24 February, according to the World Health Organization. Outside of China, 2,069 cases have been confirmed across 29 other countries, resulting in 23 deaths.

In the US, 14 cases have been confirmed, with a separate 39 cases confirmed in persons repatriated to the country. The first participant enrolled in the NIAID study was one of the citizens quarantined on the cruise ship the Diamond Princess which docked at Yokohama in Japan; the individual volunteered to take part in the study.

“We urgently need a safe and effective treatment for COVID-19,” commented NIAID Director and US Coronavirus Task Force member Dr Anthony S Fauci. “Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes. A randomised, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”

Matt Fellows

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