Replies to post #33371 on Humanigen Inc (fka HGENQ)

[DonDonDonDon]

But the question is still there, are they still enrolling people with CRP > 150 or age >85 since those criterias are not in the inclusion/exclusion population?
How the primary outcome has those filters but not the enrolling ?
Is this means that we may have 500 patients total but way less patients used for the primary outcome?

Good question. One theory is that the clinical trial sites webpage isn't completely updated. Another theory is that the inclusion criteria hasn't officially changed but unofficially they aren't accepting any patients with a CRP>150mg/L or >85yo any longer. Either way, patients with CRP>150mg/L or >85yo aren't part of the primary outcome and they were a small part of the LIVE-AIR trial so it shouldn't affect things much if they are still being treated in the ACTIV-5.

[ohm20]

But the question is still there, are they still enrolling people with CRP > 150 or age >85 since those criterias are not in the inclusion/exclusion population?

The NIH would not be violating their own protocol. "Unofficially" excluding patients would make the trial invalid.