Here’s how I see the interim analysis in ARDS going down:
The speed of enrollment lends itself to a majority of the 90 patients being in the moderate ARDS category (<200 mmHg). This means less mortality in the placebo group. There will be a decreased mortality rate using the cells vs. placebo, but it will not be statistically significant. In severe ARDS (<100 mmHg), you will see a more significant difference vs. placebo. However, due to the low number of severe patients enrolled, it will also not be statistically significant. I expect the trial to be able to continue to the next interim readout at 135 patients, or 45%.
Educated thoughts?
COVID ARDS interim analysis
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