Re: Ladies and Gentlemen, start your engines!!!???
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Message: Ladies and Gentlemen, start your engines!!!???
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Hey Dude - It is 28 days for the outcome results we are looking for. Below is the Intervention Model Description (4 weeks) as well as Primary (14 days) and Secondary (28 days) endpoints outcome measures.
This is an open-label, exploratory clinical study to assess the patient safety and effect of oral apabetalone for up to 4 weeks in hospitalized subjects with Covid-19 infection. Subjects at each center will be randomized into 2 cohorts to receive SOC plus apabetalone or SOC alone.
Primary Outcome Measures :
- The primary endpoint of the study is the change in WHO Ordinal Scale for Clinical Improvement at Day 14 [ Time Frame: Change in WHO Ordinal Scale for Clinical Improvement at Day 14 ]
WHO Ordinal Scale for Clinical Improvement, 8 point scale, 0 = no clinical or virological evidence of infection
Secondary Outcome Measures :
- Change in WHO Ordinal Scale for Clinical Improvement at Day 28 [ Time Frame: Study Day 28 ]
WHO Ordinal Scale for Clinical Improvement, 8 point scale, 0 = no clinical or virological evidence of infection
- Biomarkers of inflammation Interleukin-6 [ Time Frame: Study Day 28 ]
Interleukin-6 is a biomarker of inflammation
- Total time of hospitalization [ Time Frame: through study completion, an average of 28 days ]
Total time of hospitalization
- Biomarkers of inflammation Interleukin-8 [ Time Frame: Study Day 28 ]
Interleukin-8 is a biomarker of inflammation
- Biomarkers of inflammation Tumor Necrosis Factor alpha [ Time Frame: Study Day 28 ]
Tumor Necrosis Factor alpha is a biomarker of inflammation
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