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CytoDyn Inc CYDY
(Total Views: 445)
Posted On: 01/20/2021 4:19:13 PM
Post# of 153988
Posted By: KenChowder
Re: nmbr1stckpckr #73461
Quote:
Hmm, I guess I never paid attention. Do we even have secondary endpoints?



Primary Outcome Measures :
All-cause mortality at Day 28 [ Time Frame: Day 28 ]
Day 0 refers to the data of randomization/first treatment.


Secondary Outcome Measures :
All-cause mortality at Day 14 [ Time Frame: Day 14 ]
Day 0 refers to the data of randomization/first treatment.

Change in clinical status of subject at Day 14 (on a 7 point ordinal scale) [ Time Frame: Day 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.

Change in clinical status of subject at Day 28 (on a 7 point ordinal scale) [ Time Frame: Day 28 ]
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.

Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. [ Time Frame: Day 14 ]
The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine














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