Gilead launches phase 3 trials of coronavirus antiviral remdesivir
Gilead has said it has begun two phase 3 trials of its potential COVID-19 coronavirus antiviral remdesivir in adults affected by the disease, expanding ongoing research in the US and China.
The California-based pharma said the randomised, open-label, multicentre studies will enrol around 1,000 patients at medical centres primarily across Asian countries, as well as other countries with high numbers of diagnosed cases, beginning in March.
Gilead said the FDA had rapidly reviewed and accepted its application to begin clinical trials of remdesivir against the novel coronavirus, adding that the trials will assess two intravenous dosing durations of remdesivir.
There are already two trials, China’s Hubei province led by the China-Japan Friendship Hospital, as well as a US-based study led by the National Institute of Allergy and Infectious Diseases (NIAID) announced earlier this week.
Gilead has donated the drug and provided scientific input for these studies, with results from those in China expected in April.
One study will randomise around 400 patients with severe clinical manifestations of COVID-19 to receive either five or 10 days of remdesivir.
The second study will randomise around 600 patients with moderate symptoms to receive five or 10 days of remdesivir or standard of care alone.
Success in the first study will be measured against an endpoint of normalisation of fever and oxygen saturation sustained for at least 24 hours through to day 14.
The second study will measure efficacy of remdesivir by looking at the proportion of participants in each group discharged by day 14.
Gilead made the announcement amid a sense of mounting crisis around the coronavirus outbreak, with French president Emmanuel Macron saying an epidemic is “inevitable” in the country.
His remarks follow the first reported death from coronavirus in France, as the disease spreads across Europe from a hotspot in the north of Italy.
Australia’s prime minister Scott Morrison went further, saying that “there is every indication that the world will soon enter a pandemic phase of the coronavirus” as the country began emergency measures to prevent it from spreading.
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