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.