Gilead has initiated two Phase 3 clinical studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19 following the U.S. Food and Drug Administration’s (FDA) rapid review and acceptance of Gilead’s investigational new drug (IND) filing. These randomized, open-label, multicenter studies began enrolling patients in March 2020 and will enroll a total of approximately 1,000 patients in the initial phase of the studies, in countries with high prevalence of COVID-19.
The first of two studies will evaluate the safety and efficacy of both a 5-day and a 10-day dosing duration of remdesivir, in addition to standard of care, for patients with severe manifestations of COVID-19. The second study will evaluate the safety and efficacy of the same dosing regimens of remdesivir in addition to standard of care for patients with moderate manifestations of COVID-19, compared with standard of care alone.
Health authorities in China have initiated two clinical trials in patients who have been infected with COVID-19 to determine the safety and efficacy of remdesivir as a potential treatment for the coronavirus. The two studies are being coordinated by the China-Japan Friendship Hospital and are being conducted at multiple sites in Hubei province. Gilead is providing study drug at no charge and provided input on study design and conduct.
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