The Brilacidin Phase 2 studies will not have to be "good" to be successful because the present antivirals studied have not shown efficacy in treating Covid 19 patients with moderate to severe disease.
Any trend pointing to possible lower mortality, reduced complications, lower numbers needing Ventilators,ECMO,and reduced oxygen usage, shorter recovery times, shorter hospitalization rates, will all send Brilacidin to a stage 3 trial.
The inflammatoy markers, viral tests and immunological tests should confirm the biologic effect of Brilacidin
Of course I expect the trial to confirm the safety of Brilacidin shown in the previous studies.
The study guidelines for measuring success are list below from the Clinical trials .gov website
From Brilacidin Phase 2 clinical trials .gov
Primary Outcome Measures :
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 :
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.
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)
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
Proportion of subjects achieving at least one category improvement in clinical status [ Time Frame: Day 8, Day 15, Day 29 ]
Proportion of subjects achieving at least two category improvement in clinical status [ Time Frame: Day 8, Day 15, Day 29 ]
Time to at least one category improvement in clinical status [ Time Frame: Day 1 through Day 29 ]
Time to at least two category improvement in clinical status [ Time Frame: Day 1 through Day 29 ]
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 ]
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
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
Other Outcome Measures:
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]
Measured in days
Time to discharge [ Time Frame: Day 1 through Day 29 ]
Measured in days
Duration of invasive mechanical ventilation [ Time Frame: Day 1 through Day 29 ]
Measured in days (if applicable)
Duration of supplemental oxygen support [ Time Frame: Day 1 through Day 29 ]
Measured in days (if applicable)
Duration of extracorporeal membrane oxygenation (ECMO) [ Time Frame: Day 1 through Day 29 ]
Measured in days (if applicable)
Proportion of subjects with no oxygen therapy (and/or peripheral oxygen saturation SpO2 > 93% on room air) [ Time Frame: Day 8, Day 15, Day 29 ]
Subjects not using supplemental oxygen
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]
Incidence of death
Change from baseline in disease biomarkers [ Time Frame: Day 1 through Day 29 ]
Concentrations of C-reactive protein (CRP), ferritin, lactate dehydrogenase (LDH), D-dimer, troponin hs, absolute neutrophil count
Change from baseline in inflammatory cytokines [ Time Frame: Day 1 through Day 15 ]
Concentrations of interleukin (IL)-1ß, IL-6, IL-10, total IL-18, tumor necrosis factor (TNF)-a
Change from baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) viral load [ Time Frame: Day 1 through Day 29 ]
Concentrations of SARS-CoV-2 from nasopharyngeal (or oropharyngeal) samples
Brilacidin measurements [ Time Frame: Day 1 through Day 4 ]
Concentrations of Brilacidin from plasma samples
GLTA,Farrell
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