Gilead announced that the U.S. FDA has rapidly reviewed and accepted Gilead’s investigational new drug (IND) filing for remdesivir for the treatment of COVID-19. Gilead has now initiated two Phase 3 clinical 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 at medical centers primarily across Asian countries, as well as other countries globally with high numbers of diagnosed cases, beginning in March. The studies will assess two dosing durations of remdesivir, administered intravenously.

The first of two studies will evaluate the safety and efficacy of both a 5-day and a 10-day dosing regimen of remdesivir administered intravenously in patients with severe manifestations of COVID-19. Approximately 400 participants will be randomized in a 1:1 ratio to receive remdesivir 200 mg on day one, followed by remdesivir 100 mg each day until day 5 or 10, in addition to standard of care. The primary objective of this study is to evaluate the effect of remdesivir, as measured by the normalization of fever and oxygen saturation [T < 36.6 C armpit, < 37.2 C oral, < 37.8 C rectal; and Sp02 > 94%, sustained for at least 24 hours through Day 14]. 

The second study will evaluate the safety and efficacy of a 5-day and a 10-day dosing regimen of remdesivir administered intravenously in patients with moderate manifestations of COVID-19, compared with standard of care. Approximately 600 participants will be randomized in a 1:1:1 ratio to receive remdesivir 200 mg on day one, followed by remdesivir 100 mg in addition to standard of care each day until day 5 or 10, compared with standard of care alone. The primary objective of this study is to evaluate the effect of remdesivir, as measured by the proportion of participants in each group discharged by day 14. 

About Remdesivir 

Remdesivir is a nucleotide analog with broad-spectrum antiviral activity, both in vitro and in vivo in animal models against multiple emerging viral pathogens including Ebola, Marburg, MERS and SARS. Remdesivir has been studied in healthy volunteers and in people with Ebola virus infection.

Source: Gilead

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