- There is no reason enrollment numbers are been withheld .
Interesting it appears that the trial may be recruiting patients that are NOT on ventilation so it will even be harder to show statistic significant results even if most are COVID patients .
- Patients are only followed for 28 days, this is now considered to short , FDA recommend at least 60 days.
More important if you replicate MSB very significant and positive results appear from around 35 - 45 days , This trial would not show this up.
Secondary outcome 3: This will be the one investors will be most interested in. It may be statistically significant especially if they measure at regular intervals from day 0 through to at least 60 days . Unfortunately by the way it is described we may be left with just a 28 day result which would also make it very unreliable.
Enrollment: The current situation in Sydney and unfortunately developing across Australia you would think enrollment would be very fast however MSB found that enrollment was very slow because of other trials been run. This may have settled some what however you may still be competing with several others. Hopefully Dr's would be aware of the MSB results and understand that it is a similar therapy .
Another big problem that may cause substantial loss of available patients is the trial exclusions.
"
- Received any investigational research agent within 60 days or within five half-lives of the last treatment (if the half-life of the investigational agent is known to be longer than 12 days) prior to the planned administration of study treatment."
So does this include what now would be considered standard of care drugs that have not got label extensions for COVID ARDS patients.
Sorry guys but this trial has problems, the main one , it was designed 16 months ago and much has changed since .
Good luck.
