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Posted On: 05/13/2020 4:55:18 PM
Post# of 153903
CDiddy,
No, the trial has the following primary outcome:
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.
And secondary outcomes:
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 ]
As you can see, 14 days after termination all data will be available !!!
No, the trial has the following primary outcome:
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.
And secondary outcomes:
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 ]
As you can see, 14 days after termination all data will be available !!!
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