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Tuesday, August 25, 2020 10:37:23 PM
The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.
I am very interested in Secondary outcomes 2, 3, and 4. Primary, in my mind is a given based on M/M trial. In my thinking, even though a P3 trial to meet Primary is important to the success, the secondaries, if statistically significant is NO reason to shelve this treatment for Covid. And we have to remember, this in only about Covid, not about HIV, Cancer, NASH, etc.
The SOFA score will require the data many wanted to see with in the M/M trial. They are getting data related to:
respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal.
Exciting, huh? Tough trial but if leronlimab is as good as we (most of us) suspect, this is the type of study that will show it!!!
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