This week, there have been exciting updates about two Remdesivir trials with promising results. The first was NIAID’s ACT trial (n=800) which demonstrated a reduction in the time to recovery from 15 days to 11 days in the Remdesivir treated group compared to a control placebo (p < 0.001, NIAID ACTT). In addition, the trial reported a reduced mortality rate of 8% from 11.6% although not quite reaching significance with a p= 0.059.
The second trial was from Remdesivir’s manufacturer, Gilead, in which their trial demonstrated no significant difference in clinical recovery between a 5 day and 10 day therapy of Remdesivir as shown in Table 1 (Gilead Therapeutics). Due to the manufacturing time and limited production plants, Gilead hopes that by scaling up production and demonstrating the therapy’s efficacy at lower doses, they will be able to keep up with demand.
It is important to note that while these data have been released, this is a preliminary report, and there is more to emerge from these trials as they expand and official publish reports. Nevertheless, based on this evidence, NIAID is looking to expand its ACT trial to further validate these findings. In addition, the FDA has granted an Emergency Use Authorization (EUA) for Remdesivir allowing physicians to use the drug when unable to enroll patients in clinical trials. Prior to this, Remdeisivir was used on a Compassionate Use Basis, but this promotion to EUA will make the therapy more available on the front lines for severe COVID-19 cases until there is an approved therapy. With the EUA for chloroquine/hydroxychloroquine still standing, it will be prudent for physicians to make a therapy selection based on the available clinical evidence for both drugs.
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