How can the clinical trial demonstrate Brilacidins
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Posted On: 05/23/2021 11:19:22 PM
How can the clinical trial demonstrate Brilacidins's superiority to Remdesivir if there is no placebo?
Its the catch 22 of government regulations and FDA oversight. IPIX is not to blame in the study design.
Remdesivir does not work to lower Covid19 mortality or complications.
In spite of this Remdesivir was the only antiviral approved by the FDA for Covid19 and is a part of virtually every Covid 19 study{which was one of the best arguments against approving it}.
Remdesivir is considered the "standard of care" at many hospitals.
It is unethical not to provide the standard of care in Covid19 studies.
As a result Covid 19 antiviral studies in the US are currently using Remdesivir and not a placebo in clinical trials.
How can one tell if another antiviral eg Brilacidin is superior to Remdesiviir without a placebo?
Well if the Brilacidin treatment arm substantially lowers mortality or complications then one could reasonably assume Brilacidin is effective against Covid19 {remember Remdesivir does not work}.
At this point there has been no definition of the SOC in the Brilacidin phase 2 study except as defined in the local facility. It is possible Remdesivir will only be used in the US hospitals, and it appears those numbers may be small.
So that will add to the mystery.
It will be up to the wisdom of the FDA to design the phase 3 study. Will the phase 3 study include a placebo control arm without Remdesivir...
We will have to wait and see. My guess is it will not be necessary, but who knows?
GLTA, Farrell
Its the catch 22 of government regulations and FDA oversight. IPIX is not to blame in the study design.
Remdesivir does not work to lower Covid19 mortality or complications.
In spite of this Remdesivir was the only antiviral approved by the FDA for Covid19 and is a part of virtually every Covid 19 study{which was one of the best arguments against approving it}.
Remdesivir is considered the "standard of care" at many hospitals.
It is unethical not to provide the standard of care in Covid19 studies.
As a result Covid 19 antiviral studies in the US are currently using Remdesivir and not a placebo in clinical trials.
How can one tell if another antiviral eg Brilacidin is superior to Remdesiviir without a placebo?
Well if the Brilacidin treatment arm substantially lowers mortality or complications then one could reasonably assume Brilacidin is effective against Covid19 {remember Remdesivir does not work}.
At this point there has been no definition of the SOC in the Brilacidin phase 2 study except as defined in the local facility. It is possible Remdesivir will only be used in the US hospitals, and it appears those numbers may be small.
So that will add to the mystery.
It will be up to the wisdom of the FDA to design the phase 3 study. Will the phase 3 study include a placebo control arm without Remdesivir...
We will have to wait and see. My guess is it will not be necessary, but who knows?
GLTA, Farrell
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