Gilead Sciences, Inc. initiated two Phase III studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19 (novel coronavirus). These randomized, open-label, multicenter studies will enroll approximately 1,000 patients across Asian countries, as well as other countries globally with high numbers of diagnosed cases, beginning in March.
The initiation of these studies follows the U.S. FDA rapid review and acceptance of Gilead’s investigational new drug (IND) filing for remdesivir for the treatment of COVID-19.
The new clinical studies expand the ongoing research into remdesivir, which includes two clinical trials in China’s Hubei province led by the China-Japan Friendship Hospital as well as the recently initiated trial in the U.S. led by the National Institute of Allergy and Infectious Diseases (NIAID). Gilead has donated drug and provided scientific input for these studies, with results from China expected in April.
The Gilead studies will evaluate two dosing durations of remdesivir. One study will randomize approximately 400 patients with severe clinical manifestations of COVID-19 and the second will randomize approximately 600 patients with moderate clinical manifestations of disease. The primary endpoint is clinical improvement.
Remdesivir is not yet licensed or approved. Working with government agencies, Gilead is providing remdesivir to qualified patients with COVID-19 on a compassionate use basis for emergency treatment.