MisterBlues schreef op 24 februari 2021 15:02:
Het is een mooie en volledige opsomming van kennis over Aviptadil en de onderzoeken - door Vader.
Wat ik overigens niet wist is dat NeuroRx/Javitt de FDA heeft verteld dat een 28-daags eindpunt zinloos is vanwege de geavanceerde apparaten op ICU die patiënten (te) lang in leven houden. Zie onder:
"The clinical trial was originally approved as a 28-day study at FDA's
direction. In December, NeuroRx added a 60-day endpoint based on the
recognition that the traditional 28-day endpoint adopted in the 1990s for
trials in Acute Respiratory Distress Syndrome is not appropriate for
critically ill patients with Covid-19, who are frequently maintained in the
ICU with advanced technologies well beyond this time point. NeuroRx and other
clinical trial sponsors alerted FDA to this trend and yesterday the FDA
published formal guidance^† changing the required time for measuring the
prespecified endpoint of "alive and free of respiratory failure" in critically
ill patients to 60 days. Interim data are being reported because they were
unblinded as per the original protocol and the last patient in the trial
reached day 60 yesterday. Therefore, study conduct cannot be adversely
influenced by release of these interim findings..."
Think about that - our little study led to changes in FDA guidance...