Misiu, I agree. The number we had before was 2
Post# of 148179
I agree. The number we had before was 228:114 (342 in total). Also, the primary end point was mortality rate @ 2 weeks. From release 4/1/2020:
Quote:
CytoDyn expects to enroll patients in both the Mild-to-Moderately Ill and Severely Ill protocols very quickly under the same IND that was provided with a “safe to proceed” letter from the FDA. The new protocol for Severely Ill COVID-19 patients is for 342 patients, double blinded with 2:1 ratio. Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 14 days.
Now this states:
Quote:
Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients.
Not sure if further talks with FDA changed the trial design CYDY was proposing (quite possible) or there is a mistake (unlikely). However, I think this is the last word and it makes sense from the perspective of duration, if Leronlimab is administered for two weeks one needs to wait a bit longer for the last administration to take effect (at least one more week as per Dr. B. Patterson where immunological response restoration was seen achieved in 7 days).
TBD