I just saw this thread by @MarkHoofnagle and feel compelled to respond to clarify some things.
Disclaimers: I am not an ID expert. I am a Medical Intensivist in the Military. These are not the official views of the DoD. Just my personal opinions. No financial COIs.
1/https://twitter.com/MarkHoofnagle/status/1256242036015063042 …
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I have participated only as a site-AI but I have participated in investigator meetings since the inception of this trial so I have *some* inside knowledge. 2/
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First off, this trial was conceived and protocol approved before our very first US case back in February. It is funded by NIAID. Not Gilead. Remdesivir was chosen because of its potential. Not financially motivated. Full info here.
https://clinicaltrials.gov/ct2/show/NCT04280705 …2 replies 3 retweets 50 likesShow this thread -
The early findings released this week were *preliminary*. Only 400 of the over 1000 subjects have complete data to analyze. This was an interim analysis by the DSMB to help inform the next trial. Results like these are typically not released. But these are not normal times...
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Kevin K. Chung, MD Retweeted Kevin K. Chung, MD
Info about what was released...https://twitter.com/chungk1031/status/1255548565184811008?s=20 …
Kevin K. Chung, MD added,
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Yes the Primary endpoint was changed. However, mortality was always a SECONDARY endpoint. The original primary endpoint was a complicated 8 point ordinal scale. It was merely simplified. History of changes here.
https://clinicaltrials.gov/ct2/history/NCT04280705?V_15=View#StudyPageTop …2 replies 2 retweets 43 likesShow this thread -
Replying to @chungk1031
Changing your primary ep just to “simplify” doesn’t really pass muster. If I walk in my sons room and he stops suddenly and stares at my guiltily-he did something wrong. Him telling me “nothing dad” doesn’t really change that fact
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Yep. My skeptical antennae ALWAYS start twitching wildly when I see outcome switching in a trial. It’s a HUGE red flag.
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