@fantasycurse42 There is a sub-possibility that I have seen play out in trials before. The primary endpoint may have positive results, but not be enough to be statistically significant. Their primary outcome is just taking the combo score of fever/pain/shortness of breath/cough at a singular point in time - Day 14. In the other thread I discussed my concerns about how they are defining in the scoring of mild/moderate/severe and if these are based on the impressions of the clinical staff or some more rigid guidelines. That could lead to good results but inconclusive p-values. This scenario would be called a "failed trial" but that can sometimes be a misnomer.
If this is happening, then they would look to some of the secondary endpoints to create a more full story. Here are the secondary endpoints, and I'll put in bold ones that I think they might look to balance out "good but not statistically significant" results on the primary. I put these in bold because they could make the case these are more objective and still quite meaningful. Also, they may want to see "days of hospitalization" favorable, akin to remdesivir.
- Time to clinical resolution (TTCR) [ Time Frame: Day 14 ]
- Change from baseline in National Early Warning Score 2 (NEWS2) [ Time Frame: Days 3, 7, and 14 ]
This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). Higher scores mean a worse outcome.
[*]Change from baseline in pulse oxygen saturation (SpO2) [ Time Frame: Days 3, 7, and 14 ]
[*]
Change from baseline in the patient's health status on a 7-category ordinal scale [ Time Frame: Days 3, 7, and 14 ]
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. Lower scores mean a worse outcome.
[*]Incidence of hospitalization [ Time Frame: Day 14 ]
[*]Duration (days) of hospitalization [ Time Frame: Day 14 ]
[*]Incidence of mechanical ventilation supply [ Time Frame: Day 14 ]
[*]Duration (days) of mechanical ventilation supply [ Time Frame: Day 14 ]
[*]Incidence of oxygen use [ Time Frame: Day 14 ]
[*]Duration (days) of oxygen use [ Time Frame: Day 14 ]
[*]Mortality rate [ Time Frame: Day 14 ]
[*]Time to return to normal activity [ Time Frame: Day 14 ]
Then of course you can add on my theory of them being contractually obligated to some big pharma company to share the results with them prior to the public in case there is interest in some buyout. Unlikely, but not impossible.