Gilead Sciences on Wednesday announced the initiation of two Phase III trials to evaluate the safety and efficacy of its experimental broad-spectrum antiviral remdesivir in adults diagnosed with COVID-19. According to the company, the studies will enroll roughly 1000 patients at medical centres mainly across Asian countries, as well as other countries around the world with high numbers of diagnosed cases, beginning in March.
Specifically, one study will randomise approximately 400 patients with severe clinical manifestations of COVID-19 to receive either five or 10 days of remdesivir administered intravenously. The primary objective is to evaluate the effect of the drug, as measured by the normalisation of fever and oxygen saturation, sustained for at least 24 hours through day 14. The second trial will randomise roughly 600 patients with moderate clinical manifestations of disease to receive five- or 10-day dosing regimens of remdesivir or standard of care alone. The main goal here will be to assess the drug's effect as measured by the proportion of participants in each group discharged by day 14.
Gilead said initiation of the trials follows the FDA's rapid review and acceptance of its investigational new drug filing for remdesivir. The news comes a day after the US National Institute of Allergy and Infectious Diseases said it launched a study  evaluating remdesivir in hospitalised adults diagnosed as having COVID-19. The RNA polymerase inhibitor, which was initially developed for Ebola, is also being tested in two clinical trials in China, with results due in April.
Merdad Parsey, chief medical officer at Gilead, said the "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."
For related analysis, see ViewPoints: Moderna, Gilead lead coronavirus charge . See also ViewPoints: Gilead gains amidst pandemic pandemonium .