Dit is alles wat je erover kan zeggen:
We had Patient number 102 on 30th September. With the rising number of Covid-Cases during October and one after other phase III trial failing (most recently Regeneron see news last Friday), I would expect that patient recruiting did accelerate over October.
Anybody has news to that ? I was wondering for the following reason:
Even if Aviptadil has strong effect in reducing mortality, 102 patients divided by 2 is 51. According to the study protocol, it was estimated that the mortality could be arround 50 %. However, some aspects improved in the treatment of Covid-19 and maybe also dexamethason had an effect.
What I am trying to say: even if Aviptadil works very well, there is obviously no guarantee that we can make the statistical signficance already with 102 patients, but likely with 144.
I think it is most important that the DMSC allows to continue with this trial as a minimum - if so, that would mean that the DMSC sees at least a trend in favour of Aviptadil and that there is a reasonable chance to hit the required statistical significance.
DMSC could recomment to stop this trial if:
- negative: considerable side effects (I do not expect), or futility (if there is no trend in favour of Aviptadil)
- positive: statistical significance of mortality reduction
It would be neutral-positive if we need to continue, because that would mean, not futile, interim result in favour of Aviptadil, but patients needed to hit statistical signifcance.
Sometimes the DMSC is proposing modifications of the trial - that is still possible. DMSC would only do so, if there were some data in favour of Aviptadil and to adapt the trial to allow the trial to hit statistical significance.