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Re: C-20 post# 212560

Sunday, 07/24/2022 6:02:48 PM

Sunday, July 24, 2022 6:02:48 PM

Post# of 233246
Not according to the US FDA- LL has meet endpoints in 2 trials for 2

With the conclusion of both the CD10 and CD12 clinical trials, it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19. In the smaller study that CytoDyn conducted in patients with mild-to-moderate COVID-19 disease (CD10), there was no observed effect of the drug on the study’s primary endpoint or on any of the secondary endpoints.

The CD10 trial results showed no clinically meaningful differences in average change in “total clinical symptom score” from baseline to Day 14 between study arms (-3.5 in the leronlimab group versus -3.4 in the placebo group). Additionally, none of the secondary endpoints were met in this study,

The larger trial that CytoDyn conducted in patients with severe COVID-19 disease (CD12) also failed to find any effect of the drug on the primary study endpoint, with no difference seen in mortality (20.5% in the leronlimab treatment group and 21.6% in the placebo treatment group); or on any of the secondary endpoints, for example, with no difference on the average length of hospitalization (21.4 days in both the leronlimab and the placebo treatment groups).

https://www.fda.gov/drugs/drug-safety-and-availability/statement-leronlimab?Mon,%2017%20May%202021%2014:59:28%20EDT
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