Commentary on "Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open label non-randomized clinical trial" by Gautret et al.

Journal of Market Access & Health Policy
Mondher Toumi, Samuel Aballea

Abstract

The results of a clinical trial comparing hydroxychloroquine with or without azithromycin to the standard of care for the treatment of COVID-19 were recently published by Philippe Gautret et al. This study provides outstanding results for the combination of hydroxychloroquine and azithromycin over the standard of care, but the evidence was deemed insufficiently robust to warrant a public health decision to widen the use of hydroxychloroquine for the treatment of COVID-19. We provide a scientific critical review of the Gautret et al. publication, put the results in the context of the current knowledge, provide an evaluation of the validity of the results (from a methodologic perspective), and discuss public health implications. The study has a number of limitations, including small sample size, lack of comparability between patients in active treatment and control arms, lack of blinding, use of interim analyses without controlling for the risk of type 1 error, use of analysis in the per-protocol population instead of the intention-to-treat population, and inconsistencies between the study protocol and article. However, none of these observations is of a nature to reverse the conclusions. The study brings useful knowledge consist...Continue Reading

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Citations

Jun 5, 2020·Clinical Rheumatology·Sebastián IbáñezOmar Valenzuela
Jul 18, 2020·The Medical Journal of Australia·Irani ThevarajanBenjamin C Cowie
Jun 17, 2020·Dermatologic Therapy·Jelena Stojkovic-Filipovic, Martina Bosic
Aug 6, 2020·Reviews in Medical Virology·Niyati ShahLancelot D'Cruz
Apr 29, 2020·Lupus Science & Medicine·Anca D AskanaseJill P Buyon
Aug 3, 2020·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Guiju GaoZhihai Chen
Aug 28, 2020·Expert Review of Anti-infective Therapy·Daniel Echeverría-EsnalSantiago Grau

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Methods Mentioned

BETA
PCR

Clinical Trials Mentioned

NCT04316377
NCT04315896
NCT04308668
NCT04318015

Software Mentioned

SOLIDARITY

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