Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

There are 2 references to the 60 day mark in the trial register:
1. "A follow-up visit at Day 60(±10), by telephone call, is also included to confirm patient status."

I have no idea how they can expect the patient to assess their own status given that it can be complicated. I guess they can be expect to know if they've still "recovered", which requires one of these statuses:

Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate);
Not hospitalized, limitation on activities and/or requiring home oxygen;
Not hospitalized, no limitations on activities.

But merely asking the patient over the phone is a control failure so I hope it's not important.


2. "Incidence of treatment-emergent adverse events [ Time Frame: Day 1 through Day 60 ]
Treatment-emergent Adverse Events (TEAEs) have onset dates on or after the study treatment start date"

Again, can that be properly assessed by the patient who may or may not be monitored and/or in the hospital setting?