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But the one that interests me is the French open-labeled non randomized clinical trial on HCQ + Azithromycin against #COVID19 infection, largely publicized. Details are here https://www.mediterranee-infection.com/wp-content/uploads/2020/03/Hydroxychloroquine_final_DOI_IJAA.pdf …pic.twitter.com/KPbaUgIgAf
This is a small clinical trial (n=42 in total). Inclusion criteria in short moderate #COVID19 infection (positive viral load). Exclusion criteria, allergy, long QT syndrome.... In total 42 enrolled, 6 drop out including 3 in ICU. Total 20 HCQ vs 16 controls.
Clinical presentation seemed similar between HCQ & control but sample size is so low, difficult to conclude really. Seriously underpowered. Outcome from the study is based on viral load only and not on clinical outcome and I can see a major flaw here as clinical outcome critical.pic.twitter.com/XgaDnm34bh
So 16 patient received no treatment, 14 patients received HCQ only (200 mg/ day) and 6 patients received HCQ (200 mg/day) + Azithromycin to prevent surinfection (on clinical judgement). The treatment was for 10 days and outcome on viral load (nasopharyngeal swabs)
The results showed a reduction of the viral load from HCQ and HCQ + Azithromycin treated patients compared to controls. Looks spectacular but wait .... No error base on these graphs. So I looked at the suppl datapic.twitter.com/UdN2y6779X
Looking at supplementary Table 1, most of the controls had viral load qualitatively detected or the PCR was not done !!!! . Only 4 out of 16 controls had a proper measure of the viral load !!!! This is insane !pic.twitter.com/hDhKewVcTu
In short, all this hype on the clinical trial is based on a open label, non randomized and underpowered clinical trial on HCQ treatment against #COVID19 with viral load as an outcome that was not properly measured in 2/3 of the control cohort !!!
So to answer the question: What is the evidence of justifying using HCQ or CQ as a prophylactic or curative treatment against #COVID19. The simple or short answer is NONE. To ascertain it, we need a proper and powered randomized clinical trial
While I understand we are in a #COVID19 pandemic, there is no reason or whatsoever to throw away all the evidence based medicine and not doing rigorous science or a randomized clinical trial !
And the 6 dropout are in the hydroxychloroquine group ONLY including one death !!
That’s insane if true. Is it verified that they dropped out after treatment was administered?
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