General Stock Ideas

[gfp927z]

Ombow, Here are the primary and secondary endpoints for the severe Covid trial (below). The primary endpoint looks clear enough, mortality at day 28, so a prolonged data analysis taking weeks presumably means they are slicing and dicing data with respect to the secondary endpoints. That's what happened with the mild/mod trial, a failed primary endpoint but some success with the secondaries.

One complicating factor to consider is that Leronlimab is reportedly better at preventing the cytokine storm than reversing it (or vice versa). Last year one of the PhD type science posters on the CYDY and HGEN boards explained to me why this severe trial is far from a slam dunk. He said the severe trial design did not put Leronlimab in an optimal position to show what it could do. I can't remember the exact details, but his reasoning seemed compelling enough to put me off the stock. I had been figuring the mild/mod trial would disappoint, but that the severe trial should have an excellent chance, but he shot down that idea with sound scientific reasoning.

Anyway, be careful, because this is shaping up to be a disappointment. The long delay is especially disconcerting. On the other hand, what do I know, I thought Cortex was a great stock lol. Just be careful not to bet too much..



https://clinicaltrials.gov/ct2/show/NCT04347239?term=leronlimab&draw=2&rank=5


Primary Outcome Measures :

All-cause mortality at Day 28 [ Time Frame: Day 28 ]
Day 0 refers to the data of randomization/first treatment.


Secondary Outcome Measures :

All-cause mortality at Day 14 [ Time Frame: Day 14 ]

Day 0 refers to the data of randomization/first treatment.

Change in clinical status of subject at Day 14 (on a 7 point ordinal scale) [ Time Frame: Day 14 ]

A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Change in clinical status of subject at Day 28 (on a 7 point ordinal scale) [ Time Frame: Day 28 ]

A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. [ Time Frame: Day 14 ]

The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine

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