8/n Based on the protocol, that implies the sequence of events went like this: 1. patient tests positive, randomized and started treatment 2. Day 2, patient tests Ct>35 3. Day 4, patient tests Ct>35
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9/n This is an issue for two reasons - firstly, it's not what the authors said they'd do. Secondly, it means that they are excluding people WHO MEET THEIR PRIMARY OUTCOME (i.e. Ct>30) after randomization and treatment has started
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10/n This makes absolutely no sense to me. These people were randomized and treated, and they met the inclusion criteria pre-registered by the authors. Why were they excluded?
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11/n If you add these people back in, the results of the study entirely lose their significance At day 10, this would be 87% of the ivm and 77% of the control reaching the primary endpoint, p=0.16pic.twitter.com/UjgaGpjYFw
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12/n In addition, the authors pre-registered 3 primary outcomes. I can only see one (viral clearance) properly assessed in the paper (shedding is somewhat assessed, but it looks like they didn't get enough samples to statistically analyse this)pic.twitter.com/wv4hnBhNNE
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13/n Anyway, the main issue is that, if you use the pre-registered protocol, the study appears to have null results And yet, reported as positive to massive worldwide acclaim
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14/n This has nothing to do with fraud, takes literally minutes to check, and I encourage everyone to do so. Please let me know if I've made an error somewhere
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15/n Also, to be clear - I'm not accusing the authors of any research misconduct, this is just very basic due diligence that everyone should do for any trial that they read
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16/n Also worth noting that it is entirely possible the study still has some positive results when you add these patients back in - the point is their primary outcome, which is the main thing reported, seems to change substantially when these people are included!
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Replying to @GidMK
Also important to note that the manufacturer of the testing device used in the study recommends a CT of >40 as negative for covid, which means that the numbers below that are less reliable.
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Do you have a reference for that? If true, it would rather obviate the results
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