AGN COVID Interim Outcome: What to expect? Perhaps a 2 point scale difference i.e 5 to 3 or 6 to 4 on 0-7 scale (75 patients wont allow to perform statistical analysis) so a TREND in decline of score across patients for Day
3, 5, 8, 11, 25 will be GOOD. Primary Endpoint for AGN is -
NCT04382924 - Measuring change of clinical status (on the WHO 7 point scale) at Day 15 with 20/40mg NP 120 vs SOC. Score 0 = Uninfected, Score 1/2= Ambulatory, Score 3/4=Hospitalized mild disease, Score 5/7=Hosp severe disease and Score8=Death
Now, this same scale has been used widely such as in COVID trials Sanofi's Sarilumab NCT04327388 or Gilead Remdesivir NCT04327388
Now a company can evaluate in terms of %age of patients improving on this scale (going from 7 towards 0) or in terms of odds of improvement (if you have a big Ph3 trial) or 2 score decline at last day of treatment.
- Any Score improvement at Day 15- if NP 120 shows an improvement of 40-50% in either 40mg or 20mg+Standard of care vs Standard of care alone showing 10-20% improvement then DELTA of 20-30% would be considered very good.
- 2 point scale improvement at Day 15- For this Remdesivir showed 54% improvement in treatment arm at Day 10, so if NP 120 (esp higher dose) can showcase 40% at Day 15 then it will be considered good. You can refer to this study conducted by Gilead interim pub https://www.nejm.org/doi/10.1056/NEJMoa2015301 which sets a good benchmark for comparison.
Remember Safety on these trials is the BIG component - If patients show even a slight Treatment Related Severe Event then the efficacy wont matter much. But as NP 120 has been used for such a long time, I am pretty sure it should not be an issue.