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Posted On: 08/06/2020 2:45:30 PM
Post# of 149272
If the most clinically significant secondary endpoints show statistically improvement, we should be golden, especially if they show improved news score, lower incidence of mechanical ventilation and lower mortality.
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 ]
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 ]
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