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(1/n) Raoult’s team reported the result of hydroxychloroquine + azithromycin trial to treat COVID19 for > 1k patients.

mediterranee-infection.com/wp-content/upl…

mediterranee-infection.com/wp-content/upl…

Once again, data is broken, and I smelled their anxiety several days ago.


Threads🔻
(2/n) I closely monitor IHU’s COVID-19 website since the birth on 3/26.

mediterranee-infection.com/covid-19/

This website reports the number of COVID positives & death in APHM/IHU, and num of positives & death with >3d treatment. Some major discrepancies have been found.

website data:
(3/n)

Suspicious numbers:

3/30: number of patients with “H+A” treatment -8

4/4: no update

4/5: total death + 1, BUT “H+A” death +2. (NOBEL PRIZE PLEASE!)

4/5-4/6: >10k increase in total tests, >2k increase in total positive.

4/8: Total tests -10k, total positives -1.7k
(4/n)

I had a gut feeling on 4/6 that they will take “some” action since the death in H+A start to increase dramatically.

What a coincidence!
-No data on 4/7
-Massive data loss on 4/8
-Rush a preprint out on 4/9 which reports the data till 3/31
(5/n)
Let’s go back to the preprint.

On April 6th, Raoult reported 20 ICU, and 7 death in Oz’s show.

(20 ICU, directly from Raoult)

(7 death based on Oz)

The abstract:
(6/n)

I understand that the preprint might have been written several days ago.

However, by the time H+A group had 5 death, there were 3005 positives, and 1818 patients received 3d H+A treatment according to the website data.

The abstract:
(7/n)

Table 1. 1061 pts were from 3/3 – 3/31. OK.

On 3/31, website said there were 1283 patients that completed 3d H+A, and 1 death. Since the trial protocol was approved on 3/6, no patients received H+A before 3/3.

So, total should be 1283 or 1061? Need clarification.
(8/n)

Intriguingly, there is a significant increase in the treatment group since 3/26 (+1782). Only +733 in the “control” group.

We can assume that most new patients were enrolled into H+A treatment group.

(ignore the suspicious dashed line, please)
Due to this imbalance in enrollment, they should give more time to evaluate the outcome from treatment group.

But where is the data for this conclusion?

Abstract:
(9/n) Conclusion

The data management is a disaster. No matter combo work or not, Raoult's team doesn't have a good system to handle the clinical data from thousands of patients properly.

Cannot wait to see the data from the other 1k patients who already received 3d treatment.
I assume that researchers & clinicians will be more careful in managing data for randomized trial, because it's obviously harder to trace the numbers once lost.

But observational trial should not be the excuse of random numbers.
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