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Monday, March 08, 2021 8:22:56 AM
"As a consequence of an imbalance among enrolled patients over 65 years of age and under 65, an “age adjustment” analysis was performed, which resulted in the following primary endpoint analysis:
4. Statistically significant results (p-value = 0.0319) reported for the primary endpoint (all-cause mortality at Day 28) in participants receiving leronlimab + “commonly used COVID-19 treatments” compared to participants who received “commonly used COVID-19 treatments” alone in the placebo group in the overall modified intent-to-treat (“mITT”) population.
5. Statistically significant results (p-value = 0.0552) reported for the primary endpoint (all-cause mortality at Day 28) among participants who received dexamethasone as the prior or concomitant SoC for COVID-19, compared to patients who received dexamethasone (without leronlimab) as SoC therapy in the overall mITT population.
6. Amongst all patients in mITT, the primary endpoint (all-cause mortality at Day 28) was not statistically significant. When age adjustment was conducted, the primary endpoint was much closer to statistically significant value. Of note, the reduction of mortality in this population of 65 years and younger leronlimab arm had more than 30% less mortality than placebo and 9% less mortality in participants over 65."
The new trial for critical will show SS.
GLTU/A.
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