Sunday, September 04, 2022 1:39:09 PM
1) The study was underpowered so the results were heavily skewed against the primary endpoints due to several key sites being overwhelmed (at 200% capacity) with patient beds in parking lots. This threw off the ability to apply aviptadil properly as designed.
2) IMO the study should have had endpoints at 90 days rather than 60 days. 10 of the patients were essentially almost cured by 60 days, but had to be kept in the hospital due to "other" (although related) complications.
I also feel that the definition of the primary endpoint was toooo ambitious. It did not factor in 'improvement' levels.
Primary Endpoint: -- Alive and free from respiratory failure at day 60
All in all, the study was too small, which permitted adverse skewing of results from issues outside the control of the doctors.
It will take a while, but Dr. Leuppi study results (India) should breath a new life into aviptadil !!!
JMHO
https://journals.lww.com/ccmjournal/Fulltext/9900/The_Use_of_IV_Vasoactive_Intestinal_Peptide.40.aspx?fbclid=IwAR1Ek7tEprCDugXiPm-BrF3qwD8PAq5rQbr5eQKXG75fed26QlNeG50t8qo
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