Ongoing clinical trials:
Manufacturing company has initiated two more randomized, open-label, multi-center Phase III clinical trials for remdesivir, the SIMPLE studies, in countries with high prevalence. The first SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing regimens of remdesivir in hospitalized patients with severe COVID-19. The initial phase of the study randomized 397 patients in a 1:1 ratio to receive IV remdesivir 200 mg on the first day, followed by remdesivir 100 mg each day until day 5 or 10, in addition to standard of care. An expansion phase of the study was recently added and will enroll an additional 5,600 patients, including patients on mechanical ventilation. The study is being conducted at 180 trial sites around the world, including sites in the United States, China, France, Germany, Hong Kong, Italy, Japan, Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan and the United Kingdom. A second SIMPLE trial is evaluating the safety and efficacy of 5-day and 10-day dosing durations of remdesivir administered intravenously in patients with moderate manifestations of COVID-19, compared with standard of care. The results from the first 600 patients of this study are expected at the end of May.[15]Adaptive COVID-19 Treatment Trial (ACTT) has been conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir. Preliminary results indicated that patients who received remdesivir had a 31% faster time to recovery than those who received placebo (p<0.001). Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit. WHO is conducting a n adaptive, randomized, open-label, multi-center clinical trial of the safety and efficacy of remdesivir and three other investigational treatments in hospitalized adults diagnosed with COVID-19.