Randomized Controlled Trials for Remdesivir
An early randomized controlled trial of Remdesivir trial in China
[12], was forced to stop early because of difficulty recruiting
COVID-19 patients as the outbreak in the country was brought under
control. 237 patients aged over 18 from 10 hospitals in Wuhan were
included in the study. Patients were randomly assigned to a treatment
group (158 to remdesivir and 79 to placebo). The primary endpoint was
time to clinical improvement. Remdesivir, unfortunately, was not
associated with a difference in time to clinical improvement (hazard
ratio 1·23 [95% CI 0·87–1·75]). Adverse events were reported in
102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo
recipients. Remdesivir was stopped early because of adverse events in 18
(12%) patients versus four (5%) patients who stopped placebo early
[12]. However, it is difficult to imply that Remdesivir is not
useful against COVID-19 based on this study alone.
The National Institute of Allergies and Infectious Diseases (NIAID), NIH
initiated the Adaptive COVID-19 Treatment Trial (ACTT), a double-blind,
randomized, placebo-controlled phase 3 trial to evaluate the safety and
efficacy of Remdesivir compared with a placebo (NCT04280705) [13].
1063 patients have been recruited in US, UK and Singapore. The primary
endpoint has been defined as being well enough for hospital discharge or
returning to normal activity level with multiple other secondary
endpoints [2]. While official results have not been published, the
NIH announced that preliminary results have indicated that patients who
received Remdesivir had a 31% faster time to recovery than those who
received placebo (p<0.001). The median time to recovery was 11
days for patients on Remdesivir compared with 15 days for those on
placebo. Moreover, mortality was 8% for the group receiving Remdesivir
versus 11.6% for those in the placebo arm (P=0.059) [14].