From another blog:
As noted, the interim evaluation is for efficacy. DSMC can, based on their assessment of the data, recommend stopping the trial as a success, or modification (CD12 is an adaptive trial).
The primary and secondary endpoints will be evaluated. What level of success/statistical significance to prompt a response is a bit uncertain (at least to me).
P<0.05 in primary would have to be released. I don't know what would happen if primary insufficient but secondary are. Likely continue to full enrollment, though considering the pressing nature (Pandemic and Trump re-election), maybe EUA would be granted, especially in consideration of EIND and CD10 as well.
Primary endpoint is mortality at day 28.
Secondary endpoints:
1.Mortality at day 14
2. Change in clinical status day 14 on 7 point ordinal scale (A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.)
3. Change in clinical status day 28
4. Change from baseline in sequential organ failure assessment