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
References
Apr 29, 1995·BMJ : British Medical Journal·F DavidoffR Smith
Dec 31, 1993·Annals of the New York Academy of Sciences·A D Oxman, G H Guyatt
Sep 8, 2004·Biochemical and Biophysical Research Communications·Els KeyaertsMarc Van Ranst
Sep 8, 2011·Perspectives in Clinical Research·Sandeep K Gupta
Jan 28, 2020·Lancet·Chaolin HuangBin Cao
Feb 6, 2020·Cell Research·Manli WangGengfu Xiao
Feb 20, 2020·Bioscience Trends·Jianjun GaoXu Yang
Feb 25, 2020·JAMA : the Journal of the American Medical Association·Zunyou Wu, Jennifer M McGoogan
Mar 8, 2020·Lancet·Guanghai WangFan Jiang
Mar 8, 2020·International Journal of Antimicrobial Agents·Philippe ColsonDidier Raoult
Mar 10, 2020·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Xueting YaoDongyang Liu
Mar 17, 2020·Journal of Korean Medical Science·UNKNOWN Korean Society of Infectious DiseasesUNKNOWN Korea Centers for Disease Control and Prevention
Mar 21, 2020·Cell Discovery·Jia LiuManli Wang
Mar 25, 2020·International Journal of Antimicrobial Agents·Philippe GautretDidier Raoult
Mar 19, 2021·Cell Discovery·Jia LiuManli Wang
Oct 1, 2014·Security Dialogue·Stefan ElbeChristopher Long
Citations
Apr 21, 2020·ACR Open Rheumatology·Kaleb MichaudPatricia Katz
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
Mar 7, 2021·Life·Cinzia SignoriniTeresa Coccini