Remdesivir is a nucleotide analog that has demonstrated antiviral activity both cellular and animal models against different virus, including Ebola and SARS. However, remdesivir is not yet approved anywhere globally. Thus, the drug has to be tested in a human clinical trial setting before it becomes available to the market.
Gilead Sciences has initiated two phase 3 clinical trials that evaluate the safety and efficacy of remdesivir in adult patients diagnosed with covid-19. These trials will enroll ~1,000 patients in different medical centers all over the world. The primary focus of these studies is to rapidly determine the safety and efficacy of remdesivir as a potential treatment for COVID-19 in a short amount of time. Both trials will examine two dosing durations of remdesivir. The first clinical trial study will enroll approximately 400 patients with severe clinical manifestations of COVID-19 to receive remdesivir for 5 or 10 days. The second clinical trial second study will enroll 600 patients with moderate clinical manifestations of covid-19 disease to receive remdesivir for 5 or 10 days or standard of care alone.
Preliminary data analysis showed that remdesivir is better than placebo from the perspective of the primary endpoint, time to recovery. In the Gilead trial, recovery is defined as being well enough for hospital discharge or returning to normal activity level. Specifically, patients who received remdesivir had a 31% faster time to recovery than those who received placebo. Importantly, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. The results also proposed a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group.
Based on these data FDA granted authorization for remdesivir’s emergency use to treat the most severely ill COVID-19 patients, both adults and children. More detailed information about the Gilead remdesivir trial results will be available in the next few weeks.