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Posted On: 08/15/2021 2:26:40 AM
Post# of 154899
Agree I miss the old CDiddy.
Anyways I thought this post was worth a share. YMB lately has had some decent posters.
“The Brazil critical trial primary end point has been changed to Cumulative proportion of clinical recovery. I wasn’t sure what that meant so did a some googling.
Cumulative proportion of clinical recovery [ Time Frame: 28 days ]
Patients will be considered to have recovered if they attain categories 1, 2, or 3 on the eight-category ordinal scale within 28 days, as follows:
Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities and/or requiring home oxygen
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
Death
This is a significant change as it means any time in the 28 days the get a score of 1,2,3 they count in the “numerator” vs. only at day 28 that should significantly improve the potential of leronlimab to hit p-value.
A secondary endpoint looks at those that hit 1,2,3 at day 14, 28, 42 and 60 as well as all cause mortality for the same timeframe.
This combined with the IV injections and 4 weeks of treatment will make the trial interesting.”
Anyways I thought this post was worth a share. YMB lately has had some decent posters.
“The Brazil critical trial primary end point has been changed to Cumulative proportion of clinical recovery. I wasn’t sure what that meant so did a some googling.
Cumulative proportion of clinical recovery [ Time Frame: 28 days ]
Patients will be considered to have recovered if they attain categories 1, 2, or 3 on the eight-category ordinal scale within 28 days, as follows:
Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities and/or requiring home oxygen
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
Death
This is a significant change as it means any time in the 28 days the get a score of 1,2,3 they count in the “numerator” vs. only at day 28 that should significantly improve the potential of leronlimab to hit p-value.
A secondary endpoint looks at those that hit 1,2,3 at day 14, 28, 42 and 60 as well as all cause mortality for the same timeframe.
This combined with the IV injections and 4 weeks of treatment will make the trial interesting.”
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