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Posted On: 02/21/2022 5:17:32 AM
Post# of 154009
I made a rough comparison (yes, I have too much time) of Leronlimab ("LL"
moderate trial and Pfizers Tofacitinib ("TOF" trial which was also conducted at Albert Einstein hospitals.
The most noticeable difference of the In/ Exclusion criteria is the "Require non-invasive ventilation, invasive mechanical ventilation, or extrac" which is excluded at Pfizers TOF trial.
TOF enrollment: 289 patients
LL enrollment: 612 patients
TOF number of Exclusion Criteria: 16
LL number of Exclusion Criteria: 10
TOF start: 16.09.2020
LL start: 09.09.2021
TOF average COVID cases/ day at start: ~30k
LL average COVID cases/ day at start: ~17k
TOF trial completed: 09.01.2021
LL trial completed: started 165 days ago
TOF average COVID cases/ day at end: ~40k
LL average COVID cases/ day at end: ??? (currently ~100k)
TOF Study locations: 17
TOF Study locations: 27
My take aways:
1. It took AE 115 days to complete the TOF trial. LL trial started 165 days ago.
2. LL trial has double the number of patients.
3. I assume Omega mutation leads to less hospitalization in brazil. SOC is pretty much the same (?)
4. points for compensating different trial sizes and mutation;
a. We have 10 more study locations
b. We have 6 less exclusion criteria
c. Since mid of January we have more than double of average new COVID cases with the LL trial compared to TOF.
d. We have now 39 consecutive days with well over 100k new COVID cases in brazil which the TOF trial never had.
If Cytodyn pays the bills, there are no excuses for AE left for a low enrollment number. I assume we must have already reached the number of patients for interim analysis.
moderate trial and Pfizers Tofacitinib ("TOF" trial which was also conducted at Albert Einstein hospitals. The most noticeable difference of the In/ Exclusion criteria is the "Require non-invasive ventilation, invasive mechanical ventilation, or extrac" which is excluded at Pfizers TOF trial.
TOF enrollment: 289 patients
LL enrollment: 612 patients
TOF number of Exclusion Criteria: 16
LL number of Exclusion Criteria: 10
TOF start: 16.09.2020
LL start: 09.09.2021
TOF average COVID cases/ day at start: ~30k
LL average COVID cases/ day at start: ~17k
TOF trial completed: 09.01.2021
LL trial completed: started 165 days ago
TOF average COVID cases/ day at end: ~40k
LL average COVID cases/ day at end: ??? (currently ~100k)
TOF Study locations: 17
TOF Study locations: 27
My take aways:
1. It took AE 115 days to complete the TOF trial. LL trial started 165 days ago.
2. LL trial has double the number of patients.
3. I assume Omega mutation leads to less hospitalization in brazil. SOC is pretty much the same (?)
4. points for compensating different trial sizes and mutation;
a. We have 10 more study locations
b. We have 6 less exclusion criteria
c. Since mid of January we have more than double of average new COVID cases with the LL trial compared to TOF.
d. We have now 39 consecutive days with well over 100k new COVID cases in brazil which the TOF trial never had.
If Cytodyn pays the bills, there are no excuses for AE left for a low enrollment number. I assume we must have already reached the number of patients for interim analysis.
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