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Posted On: 06/02/2020 1:56:04 PM
Post# of 154136
No. He only gets blood work; FDA is (almost) solely interested in clinical results (improvement in symptoms).
Primary outcome is a clinical score for fever, cough, muscle ache, breathing at day 14 vs day 0
Secondary outcomes are a host of other clinicals (O2 use, mortality, time to recovery, etc.)
"Other" outcomes: 1. size of lesions in chest; 2. Dr Patterson's blood panels
https://clinicaltrials.gov/ct2/show/NCT04343651
The primary outcome seems like a tough one to show significant results on because most mild/moderate patients improve on their own within 14 days. I hope their sample size is big enough.
The "other outcomes" will give very nice data for a paper in NEJM, especially if the clinicals are good.
Primary outcome is a clinical score for fever, cough, muscle ache, breathing at day 14 vs day 0
Secondary outcomes are a host of other clinicals (O2 use, mortality, time to recovery, etc.)
"Other" outcomes: 1. size of lesions in chest; 2. Dr Patterson's blood panels
https://clinicaltrials.gov/ct2/show/NCT04343651
The primary outcome seems like a tough one to show significant results on because most mild/moderate patients improve on their own within 14 days. I hope their sample size is big enough.
The "other outcomes" will give very nice data for a paper in NEJM, especially if the clinicals are good.
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