RLFTF combined several sets of data, apparently at OWS request. This data set includes the first 21 subjects randomized in the Phase 2/3 trial (which missed primary endpoint, and had WORSE mortality vs. placebo), with 10 AVP and 11 PB.
Then, they took from the EAP protocol, in which subjects who did not qualify for the Phase 2/3 randomized trial (probably too sick), were "administratively assigned" either AVP or not. Here is a big problem, in that they probably cherry picked the healthier of these sick patients to get AVP and left the really sick ones as too far gone. Here is the EAP "trial" description, which links to the protocol and consent form:
https://clinicaltrials.gov/ct2/show/NCT04453839
https://clinicaltrials.gov/ProvidedDocs/39/NC...ot_001.pdf
https://clinicaltrials.gov/ProvidedDocs/39/NC...CF_002.pdf
Anyways, they had 21 "assigned" to AVP and 24 "assigned" (not randomly) to nothing / observation / SOC.
They then added in the first 21 from the randomized trial for a total of 31 on AVP and 35 PB.
I think the answer is that they combined some really sick patients in with some cherry picked ones that got AVP that didn't meet eligibility criteria for the trial, plus the first few trial subjects in that 35.
So the SOC patients were really sick (even the ones from the trial were the first / earliest when SOC mortality was high earlier in 2020), and I think that's why you see such horrible mortality numbers in the graph from the filing of the SPAC who merged.
I agree that the Kaplan-Meier plots can be instructive in figuring out the general time course of those severe/critical patients on standard of care, in terms of when they typically die - inside of 28 days or out.
I'm sure that studies are out there somewhere. A brief search of Kaplan Meier severe covid turns up some interesting studies.
But the SPAC filing data were not typical patients. They were ones early in Covid when mortality was high, and cherry picked ones who failed trial eligibility and furthermore were "administratively assigned" not to receive compassionate use of aviptadil.
Hopefully the "administratively assigned" is a bogus description of who could get compassionate use of aviptadil, and the control group are just historical controls (as the protocol seems to indicate in some places, in others they say "concurrent controls"
. I definitely would have asked about that if it came through my IRB.
It's interesting from the protocol that they charged for aviptadil use in EAP. Does anyone know if CYDY does that? I would hope not.
Then, they took from the EAP protocol, in which subjects who did not qualify for the Phase 2/3 randomized trial (probably too sick), were "administratively assigned" either AVP or not. Here is a big problem, in that they probably cherry picked the healthier of these sick patients to get AVP and left the really sick ones as too far gone. Here is the EAP "trial" description, which links to the protocol and consent form:
https://clinicaltrials.gov/ct2/show/NCT04453839
https://clinicaltrials.gov/ProvidedDocs/39/NC...ot_001.pdf
https://clinicaltrials.gov/ProvidedDocs/39/NC...CF_002.pdf
Anyways, they had 21 "assigned" to AVP and 24 "assigned" (not randomly) to nothing / observation / SOC.
They then added in the first 21 from the randomized trial for a total of 31 on AVP and 35 PB.
I think the answer is that they combined some really sick patients in with some cherry picked ones that got AVP that didn't meet eligibility criteria for the trial, plus the first few trial subjects in that 35.
So the SOC patients were really sick (even the ones from the trial were the first / earliest when SOC mortality was high earlier in 2020), and I think that's why you see such horrible mortality numbers in the graph from the filing of the SPAC who merged.
I agree that the Kaplan-Meier plots can be instructive in figuring out the general time course of those severe/critical patients on standard of care, in terms of when they typically die - inside of 28 days or out.
I'm sure that studies are out there somewhere. A brief search of Kaplan Meier severe covid turns up some interesting studies.
But the SPAC filing data were not typical patients. They were ones early in Covid when mortality was high, and cherry picked ones who failed trial eligibility and furthermore were "administratively assigned" not to receive compassionate use of aviptadil.
Hopefully the "administratively assigned" is a bogus description of who could get compassionate use of aviptadil, and the control group are just historical controls (as the protocol seems to indicate in some places, in others they say "concurrent controls"
. I definitely would have asked about that if it came through my IRB. It's interesting from the protocol that they charged for aviptadil use in EAP. Does anyone know if CYDY does that? I would hope not.
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