I am no expert but am trying to see the bigger picture. Given that NP has said that our day 3 score is better than the placebo one assumption we can make is that leronlimab is working quickly (this fits with the 72 hour recovery we have heard from Dr. Jay, Dr. BP as well as testimonials). However, due to the fact that many m2m patients recover on their own (especially if you happen to get more "mild" patients in the placebo arm) we may not see statistical significance at days 7 or 14.
One might than conclude that we are helping patients get better quicker but that some m2m patients would very well recover on their own by days 7 and 14.
All of this has been said. What I am really curious to see are these "Other Outcome Measures"
If these show corresponding improvements that bolster that narrative than haven't we in effect nailed it? I actually think this trial is quite clever in this regard. First, you are effectively validating Dr. Patterson's proposed theory on the pathogenesis of COVID. Second, you can correlate a patients recovery with those immunological markers. And third, you may even be able to show that although a patient has recovered clinically at day 7 or 14, they may not have fully recovered immunilogically (i.e. long haulers or people who experience strange systems after leaving the hospital).
The reason I bring this up is because I was mistakenly focusing mainly on primary/secondary endpoints. I think these "other outcome measures" are very important in the m2m case.
Personally, I think a solid PR on the results would really tie these all together nicely and paint a picture of how the disease works as well as how leronlimab is clearly speeding the recovery process. I wish they could utilize graphs as Dr. Patterson did in his paper and show that although placebo patients recovered, they did so more slowly as evidenced by these immunological markers. Furthermore, if patients didn't recovery fully immunologically (even though clinically they may have) it would be fascinating to point that out as that begs for a "long hauler" trial.
One might than conclude that we are helping patients get better quicker but that some m2m patients would very well recover on their own by days 7 and 14.
All of this has been said. What I am really curious to see are these "Other Outcome Measures"
Quote:Other Outcome Measures:
Change in size of lesion area by chest radiograph or CT [ Time Frame: Day 14 ]
Change from baseline in serum cytokine and chemokine levels [ Time Frame: Days 3, 7, and 14 ]
Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages [ Time Frame: Days 3, 7, and 14 ]
Change from baseline in CD3+, CD4+ and CD8+ T cell count [ Time Frame: Days 3, 7, and 14 ]
If these show corresponding improvements that bolster that narrative than haven't we in effect nailed it? I actually think this trial is quite clever in this regard. First, you are effectively validating Dr. Patterson's proposed theory on the pathogenesis of COVID. Second, you can correlate a patients recovery with those immunological markers. And third, you may even be able to show that although a patient has recovered clinically at day 7 or 14, they may not have fully recovered immunilogically (i.e. long haulers or people who experience strange systems after leaving the hospital).
The reason I bring this up is because I was mistakenly focusing mainly on primary/secondary endpoints. I think these "other outcome measures" are very important in the m2m case.
Personally, I think a solid PR on the results would really tie these all together nicely and paint a picture of how the disease works as well as how leronlimab is clearly speeding the recovery process. I wish they could utilize graphs as Dr. Patterson did in his paper and show that although placebo patients recovered, they did so more slowly as evidenced by these immunological markers. Furthermore, if patients didn't recovery fully immunologically (even though clinically they may have) it would be fascinating to point that out as that begs for a "long hauler" trial.
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