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Posted On: 05/14/2021 3:04:16 PM
Post# of 72440
The patient enrollment portion of the trial seems to be going quite well at this point in time and we could have full enrollment (whether that be measured at 120 or 138 patients) possibly by early to mid June, though not guaranteed. Add 29 days for evaluation and that leads to about the middle of July for end of trial.
Once the 120th patient data is finalized the trial stops and further patient data (should the total enrolled be anywhere up to 138) beyond the 120th patient is not included in the trial results from what I understand.
The CRO gets the data (not sure if each site sends up data on each patient as it is finalized or altogether at the end) but IMO it would have to be individually so the CRO knows exactly which patients are in the first 120.
People talk about the "top line data" and a google search came up with the following definition of same:
"In the clinical arena, Top-line Results (regardless of the stage of the trial or the phase of the trial) speak to the statistical significance of the trial results coming out of the subject population."
So now we have to look at the primary and secondary objectives of the trial to see what the statistics are for the Brilacidin P2 trial. Following is taken from the clinicaltrial.gov website as to the primary and secondary objectives for our trial:
Primary Outcome Measures :
1. Time to sustained recovery through Day 29 [ Time Frame: Day 1 through Day 29 ]
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale with response sustained through Day 29:
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.
Secondary Outcome Measures :
1. Proportion of subjects achieving recovery status scores at Day 29 [ Time Frame: Day 29 ]
Recovery status scores are the following three categories from the ordinal scale:
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.
2. Proportion of subjects that die or develop respiratory failure by Day 29 [ Time Frame: Day 1 through Day 29 ]
Composite endpoint, defined as: Death OR Respiratory failure (requires invasive mechanical ventilation)
3. Subject Clinical status [ Time Frame: Day 1 through 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
4. Proportion of subjects achieving at least one category improvement in clinical status [ Time Frame: Day 8, Day 15, Day 29 ]
5. Proportion of subjects achieving at least two category improvement in clinical status [ Time Frame: Day 8, Day 15, Day 29 ]
6. Time to at least one category improvement in clinical status [ Time Frame: Day 1 through Day 29 ]
7. Time to at least two category improvement in clinical status [ Time Frame: Day 1 through Day 29 ]
8. 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)
9. Change from baseline in National Early Warning Score 2 (NEWS2) [ Time Frame: Day 1 through Day 29 ]
10. Incidence of treatment-emergent adverse events [ Time Frame: Day 1 through Day 60 ]
Treatment-emergent Adverse Events (TEAEs) have onset dates on or after the study treatment start date
11. Incidence of treatment-emergent graded laboratory abnormalities [ Time Frame: Day 1 through Day 29 ]
Treatment-emergent abnormalities have onset dates on or after the study treatment start date
The above primary and secondary measures IMO seem pretty easy to evaluate so the basic pass/fail of Brilacidin should be known quite early, but early enough to give "top line" results at the Virology Conference?
My heart wants to think yes but my brain says unlikely. It sure would be a show stopper if they were able to give at least a very generalized statement that the data appears to show Brilacidin quite efficacious in the trial with 0 to very minor safety issues.
If it is true that Rems... doesn't do much for patients on ventilators then there should be a tremendous statistical significance should Brilacidin prove anywhere close to the in vitro results and I believe the consensus from the SI of 426, in vitro results, past B clinical trials, etc is that Brilacidin should prove quite predictably along the numbers expected heading into the trial. I don't see any chance for a hiccup with the Rems and saline treatment showing a degree of effectiveness for ventilated patients. I hope many patients tested w/ B have the variants to further heighten the fact that B will work on all variants of CV19.
All that is left is the waiting. No need to worry about the share price until the trial is over as those wanting to see the demise of IPIX will do just about anything in the next 2 months as their butts are on the line in a very big and disastrous way IMO.
Once the 120th patient data is finalized the trial stops and further patient data (should the total enrolled be anywhere up to 138) beyond the 120th patient is not included in the trial results from what I understand.
The CRO gets the data (not sure if each site sends up data on each patient as it is finalized or altogether at the end) but IMO it would have to be individually so the CRO knows exactly which patients are in the first 120.
People talk about the "top line data" and a google search came up with the following definition of same:
"In the clinical arena, Top-line Results (regardless of the stage of the trial or the phase of the trial) speak to the statistical significance of the trial results coming out of the subject population."
So now we have to look at the primary and secondary objectives of the trial to see what the statistics are for the Brilacidin P2 trial. Following is taken from the clinicaltrial.gov website as to the primary and secondary objectives for our trial:
Primary Outcome Measures :
1. Time to sustained recovery through Day 29 [ Time Frame: Day 1 through Day 29 ]
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale with response sustained through Day 29:
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.
Secondary Outcome Measures :
1. Proportion of subjects achieving recovery status scores at Day 29 [ Time Frame: Day 29 ]
Recovery status scores are the following three categories from the ordinal scale:
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.
2. Proportion of subjects that die or develop respiratory failure by Day 29 [ Time Frame: Day 1 through Day 29 ]
Composite endpoint, defined as: Death OR Respiratory failure (requires invasive mechanical ventilation)
3. Subject Clinical status [ Time Frame: Day 1 through 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
4. Proportion of subjects achieving at least one category improvement in clinical status [ Time Frame: Day 8, Day 15, Day 29 ]
5. Proportion of subjects achieving at least two category improvement in clinical status [ Time Frame: Day 8, Day 15, Day 29 ]
6. Time to at least one category improvement in clinical status [ Time Frame: Day 1 through Day 29 ]
7. Time to at least two category improvement in clinical status [ Time Frame: Day 1 through Day 29 ]
8. 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)
9. Change from baseline in National Early Warning Score 2 (NEWS2) [ Time Frame: Day 1 through Day 29 ]
10. Incidence of treatment-emergent adverse events [ Time Frame: Day 1 through Day 60 ]
Treatment-emergent Adverse Events (TEAEs) have onset dates on or after the study treatment start date
11. Incidence of treatment-emergent graded laboratory abnormalities [ Time Frame: Day 1 through Day 29 ]
Treatment-emergent abnormalities have onset dates on or after the study treatment start date
The above primary and secondary measures IMO seem pretty easy to evaluate so the basic pass/fail of Brilacidin should be known quite early, but early enough to give "top line" results at the Virology Conference?
My heart wants to think yes but my brain says unlikely. It sure would be a show stopper if they were able to give at least a very generalized statement that the data appears to show Brilacidin quite efficacious in the trial with 0 to very minor safety issues.
If it is true that Rems... doesn't do much for patients on ventilators then there should be a tremendous statistical significance should Brilacidin prove anywhere close to the in vitro results and I believe the consensus from the SI of 426, in vitro results, past B clinical trials, etc is that Brilacidin should prove quite predictably along the numbers expected heading into the trial. I don't see any chance for a hiccup with the Rems and saline treatment showing a degree of effectiveness for ventilated patients. I hope many patients tested w/ B have the variants to further heighten the fact that B will work on all variants of CV19.
All that is left is the waiting. No need to worry about the share price until the trial is over as those wanting to see the demise of IPIX will do just about anything in the next 2 months as their butts are on the line in a very big and disastrous way IMO.
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