Gilead Sciences has commenced two Phase III clinical trials of its investigational antiviral drug, remdesivir, for the treatment of Covid-19 in adults.
This announcement comes after the US Food and Drug Administration (FDA) accepted and reviewed the company’s investigational new drug (IND) application for remdesivir in this indication.
The randomised, open-label, multi-centre studies will assess the safety and efficacy of the drug in nearly 1,000 patients. A five-day and ten-day dosing regimen of an intravenous formulation of remdesivir will be tested.
The trials will mainly be conducted at sites in Asian countries impacted by the coronavirus outbreak. From March, sites will be added in other countries with a higher number of confirmed cases.
One of the trials will enrol around 400 patients with severe clinical manifestations of the novel coronavirus disease, while the second trial will involve about 600 patients with moderate clinical manifestations.
In addition to standard of care, participants will be given a 200mg dose of the drug on day one, followed by a 100mg dose every day until day five or ten.
Both trials will evaluate clinical improvement as the primary endpoint.
The primary endpoint in the first trial will be measured by the normalisation of fever and oxygen saturation. The second trial will record the measure based on the proportion of patients discharged by day 14.
Gilead Sciences chief medical officer Merdad Parsey said: “Gilead’s primary focus is on rapidly determining the safety and efficacy of remdesivir as a potential treatment for Covid-19, and this complementary array of studies helps to give us a more expansive breadth of data globally on the drug’s profile in a short amount of time.”
The initiation of these Phase III trials comes a day after the National Institutes of Health (NIH) announced a trial of remdesivir in Covid-19 patients at the University of Nebraska Medical Center (UNMC).
Two studies led by the China-Japan Friendship Hospital are already being conducted in Hubei province, the epicentre of the outbreak in China.