Replies to post #356357 on Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

Definitions per clinicaltrials.gov:
Primary Completion Date:
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

Study Completion Date:
The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit).


The primary outcome measure in this trial is defined as....
"Time to sustained recovery through Day 29 [ Time Frame: Day 1 through Day 29 ]"

So if I understand that correctly a patient who has not recovered on Day 29 has -0- days of sustained recovery and a patient who "recovers" on Day 10 and STAYS in one of the 3 categories of recovery through Day 29 has "Time to sustained recovery" of 10 days.

The point of this is that the Primary Completion Date will be 29 days from when the last patient is dosed (unless they expire before then, in which case the PCD will be 29 days from the date the next to last patient is dosed, etc).

I think this means that when the Company says it has an "Estimated Primary Completion Date : July 2021" it expects to dose patient 120 in June.


The fact that the Estimated Study Completion Date is also July 2021 is a little bit confusing in part because of the following Secondary Outcome Measure:
"Incidence of treatment-emergent adverse events [ Time Frame: Day 1 through Day 60 ]"
...and this element of the Detailed Description:
"Follow-up period (Day 4-6 through Day 60): Subjects will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 15 and 29. A follow-up visit at Day 60(±10), by telephone call, is also included to confirm patient status."

Day 29 and Day 60 for patient 120 obviously can't both occur in the same month. Can someone explain that?

The reason for this exercise was to try and guess what the EPCD and ESCD might be saying about the date on which the last participant in the study will be examined or receive an intervention to collect final data.