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. Gilead has donated the drug and provided scientific input for these studies. 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.