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Hydroxychloroquine and azithromycin study “does not meet standard”

Hydroxychloroquine and azithromycin study “does not meet standard”

Last Reviewed : 12/16/2020
Hydroxychloroquine and azithromycin study “does not meet standard”

There has been a lot of buzz around COVID-19 treatment with hydroxychloroquine and azithromycin combination. A research study published in the International Journal of Antimicrobial Agents on March 20, 2020 demonstrated a significant reduction of viral load in COVID-19 patients. The study included only 20 patients. The results of this study generated a lot of interest across the globe.

Based on this study, the president of the United States requested India to export hydroxychloroquine to the U.S. Hydroxychloroquine and azithromycin combination became part of treatment protocol at several healthcare organizations.

Dr. Raoult from IHU Méditerranée Infection, Marseille, France, was the author of the article. On April 9, 2020, he also published an abstract that included 1061 patients. The authors concluded that hydroxychloroquine and azithromycin combination significantly reduced death rate in COVID-19 patients.

On April 3, 2020, International Society of Antimicrobial Chemotherapy (ISAC) released a statement regarding the study published on March 20, 2020. ISAC stated that the study does not meet the Society’s standard. Here is the official statement:

Official Statement from International Society of Antimicrobial Chemotherapy (ISAC)

Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial (Gautret P et al. PMID 32205204)

ISAC shares the concerns regarding the above article published recently in the International Journal of Antimicrobial Agents (IJAA). The ISAC Board believes the article does not meet the Society’s expected standard, especially relating to the lack of better explanations of the inclusion criteria and the triage of patients to ensure patient safety.

Despite some suggestions online as to the reliability of the article's peer review process, the process did adhere to the industry's peer review rules. Given his role as Editor in Chief of this journal, Jean-Marc Rolain had no involvement in the peer review of the manuscript and has no access to information regarding its peer review. Full responsibility for the manuscript's peer review process was delegated to an Associate Editor.

Although ISAC recognises it is important to help the scientific community by publishing new data fast, this cannot be at the cost of reducing scientific scrutiny and best practices. Both Editors in Chief of our journals (IJAA and Journal of Global Antimicrobial Resistance) are in full agreement.

Andreas Voss
ISAC President

 

While there are several concerns regarding how the study was conducted, hydroxychloroquine still remains a promising treatment for COVID-19. National Institutes of Health (NIH), the primary federal agency to conduct medical research, recently initiated ORCHID study to look at the effectiveness of hydroxychloroquine. Azithromycin is not included in ORCHID study as there are concerns for cardiac arrest.

The results of this large, blinded, randomized, placebo-controlled trial should give further directions regarding the efficacy of hydroxychloroquine.

 

References:

  • Gautret P et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Mar 20:105949. doi: 10.1016/j.ijantimicag.2020.105949.

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