invisioner Not sure this answers your question ab
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Posted On: 10/07/2020 10:45:54 AM
Re: invisioner #60133
invisioner
Not sure this answers your question about when SOC was started, but here is some info in that regard.
The original trial version was posted on clinicaltrials.gov on 4/14/20. The following note was shown under Eligibility - Exclusion Criteria:
Note: Subject who were prescribed hydroxychloroquine or chloroquine with or without azithromycin for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents.
The sixth revision was posted on 6/10/20. The note was changed as follows:
Note: Subject who were prescribed (1) hydroxychloroquine or chloroquine with or without azithromycin, (2) Remdesivir, (3) convalescent plasma therapy, or (4) immunomodulatory treatments (including but not limited to sarilumab, clazakizumab, tocilizumab, and anakinra) for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents as part of standard-of-care.
That is the first mention of SOC that I noticed. That does not mean that SOC was not started at some earlier time.
You can look at any 2 trial versions side-by-side and the revisions are highlighted. The link below shows the 2 versions I quoted above.
https://clinicaltrials.gov/ct2/history/NCT043...udyPageTop
I am not sure that these trial descriptions are accurate and up-to-date. Example: Unless I overlooked it, it does not mention the 2-1 ratio whereas the M-M trial description notes that.
Not sure this answers your question about when SOC was started, but here is some info in that regard.
The original trial version was posted on clinicaltrials.gov on 4/14/20. The following note was shown under Eligibility - Exclusion Criteria:
Note: Subject who were prescribed hydroxychloroquine or chloroquine with or without azithromycin for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents.
The sixth revision was posted on 6/10/20. The note was changed as follows:
Note: Subject who were prescribed (1) hydroxychloroquine or chloroquine with or without azithromycin, (2) Remdesivir, (3) convalescent plasma therapy, or (4) immunomodulatory treatments (including but not limited to sarilumab, clazakizumab, tocilizumab, and anakinra) for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents as part of standard-of-care.
That is the first mention of SOC that I noticed. That does not mean that SOC was not started at some earlier time.
You can look at any 2 trial versions side-by-side and the revisions are highlighted. The link below shows the 2 versions I quoted above.
https://clinicaltrials.gov/ct2/history/NCT043...udyPageTop
I am not sure that these trial descriptions are accurate and up-to-date. Example: Unless I overlooked it, it does not mention the 2-1 ratio whereas the M-M trial description notes that.
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