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Posted On: 05/04/2021 9:39:33 AM
Post# of 72440
Note that there are several endpoints, quoted below. There should be no concerns about whether the effect (or lack thereof) of Brilacidin can be measured, with so many data points.
Quote:
Time to sustained recovery through Day 29
Proportion of subjects achieving recovery status scores at Day 29
Proportion of subjects that die or develop respiratory failure by Day 29
Clinical status is measured with an 8-point ordinal scale:
Death
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, requiring low-flow supplemental oxygen
Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate)
Not hospitalized, limitation on activities and/or requiring home oxygen
Not hospitalized, no limitations on activities
and lots of others, based on various measures of how sick they are, especially:
Time to a National Early Warning Score 2 (NEWS2) of </= 2 and maintained for 24 hours [ Time Frame: Day 1 through Day 29 ]
The NEWS2 score is based on seven clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, systolic blood pressure, pulse, level of consciousness, temperature)
Change from baseline in National Early Warning Score 2 (NEWS2) [ Time Frame: Day 1 through Day 29 ]
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