The protocol for the Severe or Critical Coronaviru
Post# of 148166
https://clinicaltrials.gov/ct2/show/record/NC...iew=record
Primary Outcome Measures:
All-cause mortality at Day 28 [ Time Frame ay 28 ]
Secondary Outcome Measures :
All-cause mortality at Day 14 [ Time Frame ay 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 ay 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 ay 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 ay 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