I am sorry but I must have missed the actual publi
Post# of 153887
(Total Views: 479)
Posted On: 04/14/2020 9:27:32 PM
I am sorry but I must have missed the actual published protocol and outcome measures on the P2b/3 trial. It may be best to wait and read it.
Which brings me to another interesting question for consideration. The P2 trial has a boat load of trial outcome measures (see text below), is this a good thing or a bad thing? I think it is good, it gives the FDA a bunch of reasons to move forward on cherry picked data, or not if one leans in the direction of the FDA being an evil demon with no loved ones they want to save.
Outcome Measures
Primary Outcome Measures :
Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) [ Time Frame: Day 14 ]
Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. [0=none, 1=mild, 2=moderate, and 3=severe]. Higher scores mean a worse outcome.
Secondary Outcome Measures :
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 ]
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 ]
Which brings me to another interesting question for consideration. The P2 trial has a boat load of trial outcome measures (see text below), is this a good thing or a bad thing? I think it is good, it gives the FDA a bunch of reasons to move forward on cherry picked data, or not if one leans in the direction of the FDA being an evil demon with no loved ones they want to save.
Outcome Measures
Primary Outcome Measures :
Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) [ Time Frame: Day 14 ]
Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. [0=none, 1=mild, 2=moderate, and 3=severe]. Higher scores mean a worse outcome.
Secondary Outcome Measures :
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 ]
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 ]
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