đ„With @DgCostagliola we have published a response to the article by Risch in @AmJEpi on the outpatient treatment of #COVIDăŒ19
There was and is no convincing evidence that #HCQ + #Azithromycin prevent hospitalisation in high-risk #COVID19 outpatientsđ
academic.oup.com/aje/article/doâŠ
There was and is no convincing evidence that #HCQ + #Azithromycin prevent hospitalisation in high-risk #COVID19 outpatientsđ
academic.oup.com/aje/article/doâŠ
In Gautret 1, that should be retracted by #IJAA, 6 patients were excluded w/o justification among the 26 treated with #HCQ. The appropriate test should compare the 14 patients who received #HCQ alone to the 6 who received the combination, and this test is not significant (p=0.39)
Risch stated that the only valid criticism against this trial is the lack of randomization. He rejects the criticism about the "small study size", saying that size matters only when no evidence is found. But no evidence is found in this study as shown above...
There are so many other criticisms of this article and many have detailed them:
- There were more missing values in the untreated group and the missing data replacement technique used favored the treated group.
- There were more missing values in the untreated group and the missing data replacement technique used favored the treated group.
-Virological assessment was different between treated/untreated groups.Patients in the untreated group were followed in another centre, raising questions on the measurement of the primary endpoint and precluding the assessment and comparison of the initial values in each group.
- An appropriate primary endpoint would be a clinical one, hospitalization for an outpatient, and progression to ICU or death for a hospitalized patient, not a virological outcome. We now know that virological outcomes are not closely related to clinical outcomes in #COVID19
- We also find worrying that the article describes a daily follow-up during 14 days and reports an ethic approval on March 6; but was published on March 20, which is impossible. This led to an ongoing inquiry by the French Drug Regulation Agency @ansm
Therefore, it is absolutely impossible to use this trial to support the use of the combination in an outpatient setting, because it does not include outpatients, its primary endpoint is not appropriate and it does not show the benefit of the combination on their primary endpoint.
The only other published study discussed in the "review", led on outpatients + hospitalized patients, with a low proportion of at-risk patients, had no control group and cannot conclude to efficacy for a disease whose natural history is spontaneous resolution for > 90% of cases
All the other studies reviewed by Risch are unpublished, poorly designed studies whose quality is even lower than the papers discussed above, but the limited space available prevents us from providing a detailed critical analysis.
We strongly think that there is no convincing evidence to support the claim made by Risch on the emergency to treat symptomatic high-risk Covid-19 patients with a combination of hydroxychloroquine with azithromycin.
I believe that this "review" should not have been published in a serious journal @AmJEpi because of its massive "cherry picking" and gross methodological shortcomings.
A pandemic is not excuse to write and publish poor research that does not correspond to scientific standards.
A pandemic is not excuse to write and publish poor research that does not correspond to scientific standards.
Huge thanks to @Tsarorius whose critical appraisal of IHU studies inspired our comment.
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