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Posted On: 09/17/2020 12:55:56 PM
Post# of 148908
SAF,
:
Primary - mortality at 28 days
Secondary endpoints
1. Mortality at 14 days
2. Change in clinical status at day 14
3. Change in clinical status at day 28
4. Change from baseline in sequential organ failure assessment
In detail from clinicaltrials.gov
https://clinicaltrials.gov/ct2/show/NCT043472...amp;rank=5
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
:
Primary - mortality at 28 days
Secondary endpoints
1. Mortality at 14 days
2. Change in clinical status at day 14
3. Change in clinical status at day 28
4. Change from baseline in sequential organ failure assessment
In detail from clinicaltrials.gov
https://clinicaltrials.gov/ct2/show/NCT043472...amp;rank=5
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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