Remdesivir Clinical Trials
The remdesivir clinical trial program was designed to answer multiple scientific questions in parallel, to rapidly evaluate the potential for remdesivir to treat COVID-19 patients.
Gilead-initiated “SIMPLE” Trials
Gilead is conducting two randomized, open-label, multicenter, Phase 3 clinical studies to evaluate the safety and efficacy of two dosing durations – 5 days and 10 days – of remdesivir in adults diagnosed with COVID-19.
The first of the two SIMPLE studies is evaluating 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. Initial study results were announced on April 29. This study was planned to enroll 400 patients and was subsequently amended to enable the enrollment of an additional 5,600 patients in an expansion phase, including patients on mechanical ventilation. The study will enroll a total of 6,000 patients overall.
The second SIMPLE study is evaluating 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. This study was planned to enroll 600 patients and was subsequently amended to enable the enrollment of an additional 1,000 patients in an expansion phase. The study will enroll a total of 1,600 patients overall. Results from this study are expected at the end of May.
COVID-19: Hetero to make Gilead’s Remdesivir in Hyderabad
N. RAVI KUMAR
MAY 13, 2020 10:20 IST
UPDATED: MAY 13, 2020 10:20 IS
Licensing pact inked; firm working with authorities for necessary studies and approvals
Generic pharmaceutical firm and leading producer of anti-retroviral drugs Hetero has entered into a licensing agreement with Gilead Sciences Inc. for the manufacture and distribution of Remdesivir in 127 countries, including India.
Also read: Coronavirus | Around 30 Indian attempts at COVID-19 vaccine, says Principal Scientific Adviser
An investigational drug, Gilead’s Remdesivir had received emergency use authorisation (EUA) from the U.S. Food and Drug Administration (USFDA) for treatment of hospitalised patients with severe COVID-19.
Announcing the deal, Hetero said Remdesivir will be manufactured at its formulation facility in Hyderabad. The facility has been approved by regulators such as the USFDA and EU, among others.
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