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Tuesday, March 09, 2021 7:01:27 AM
Biodoc describes the following problem- as the disease progresses the virus has already spread and done its direct damage. Can you make a difference if you start treatment on Day 3? or 5? Or 7? Or 10?
Next to no one would be hospitalized on Day 3 of symptoms and some would be on Day 5. As the disease progresses the CT scans and CXRs will tell you- the virus is very widespread.
Again, The data put forth by IP so far talks about mechanisms of action whose relevance is not clearly beneficial by the time the drug will be given to actual patients. That is why I have advocate from the very start a trial done on people whose symptoms were at the earliest identifiable point. Lots of those patients come to emergency depts- they want to know if they have COVID and how sick they are. Great time for a study of B for C- if you want to impact the virus very early.
The antiinflammatory and immunomodulating impact of B may play a role in COVID patients but THERE IS NO DATA TO SUPPORT IT. The GMU lab and the paper that came out have nothing to do with antiinflammatory or antibacterial(3in 1) role in B v C treatment. It is known that B has some antiinflamm impact but those are not COVID studies. B may have had some antiinflamm benefit in the distal colons of some patients with ulcerative colitis, based on the preliminary study done a few years back now. Recall that there were no controls and obv mechanism not comparable. Also B OM data does not apply
So: antiinflammatory mechanism in B v C? Nothing at all known. All guesswork. No direct studies to point to. Nothing done at GMU to support use in the current trial with respect to immunomodulation.The high SI that everyone is excited about? The 426 reference? It tells you NOTHNG about antiinflammatory benefit. Nothing at all. Because no one has a clue about what level of B is needed to mitigate COVID inflammation.
So the trial is proceeding and there may be benefit from an antiviral mechanism. And there may not be.
B is not in the lab with preincubation. B is in hospitals with patients with many days of illness with COVID already. How relevant will the SI 426 be? We can hope for some antiviral benefit .
But the antiinflammatory impact has no relevant COVID lab data no SI # and NO DOSING INFO AT ALL to support it
Cross your fingers and pray for a miracle- that is where things stand in this pivotal trial. Recall the reassurance of those who said there was a "very good" chance of success? That was just blather.
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