Gautret et al investigation

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

Follow-Up Investigation (15 July 2020)

Following on from the joint statement by ISAC / Elsevier regarding the above paper, the independent review is now complete. The results of the external methodological review, a content review and a brief editorial have been published in International Journal of Antimicrobial Agents (IJAA).

• Publishing in face of the COVID-19 pandemic (Voss et al)
  
  
• Review of: “Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial Gautret et al 2010, DOI:10.1016/j.ijantimicag.2020.105949 (F. R. Rosendaal)
  
  
• Reply to Gautret et al: hydroxychloroquine sulfate and azithromycin for COVID-19: what is the evidence and what are the risks? (Machiels et al)
  
  

 

 

Joint ISAC and Elsevier statement on Gautret et al. paper [PMID 32205204] (11 April 2020)

The use of chloroquine/hydroxychloroquine as a potential prevention or treatment for COVID-19 has been reported anecdotally but there is currently no large-scale data available on its safety and efficacy for this use. The WHO has included chloroquine/hydroxychloroquine as one of four drugs to be evaluated in the SOLIDARITY mega-trial. 

The paper entitled “Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial” (Gautret P et al. PMID 32205204) reports a small-scale trial of hydroxychloroquine as a potential treatment for COVID-19.

Concerns have been raised regarding the content, the ethical approval of the trial and the process that this paper underwent to be published within International Journal of Antimicrobial Agents. 

In response, we want to clarify that the journal’s standard peer review process was followed in the publication of this paper. To minimize potential bias, as one of the paper’s authors is the Editor in Chief of the journal, the Editor in Chief was not involved in the peer review of the manuscript, and that following the established standard process, the manuscript's peer-review was delegated to an Associate Editor. 

At present, additional independent peer review is ongoing to ascertain whether concerns about the research content of the paper have merit. Given this process of post-publication assessment is on-going, it would be premature to comment at this time. The study authors have been contacted and asked to address the concerns. Depending on the nature of their response, a correction to the scientific record may be considered in accordance with the policies of Elsevier and the Committee on Publication Ethics (COPE): https://www.elsevier.com/editors/perk/corrections-to-the-record.

Further communications following the completion of this review will be made available.

Please direct all queries to the Elsevier Newsroom: newsroom@elsevier.com 

Official Statement from International Society of Antimicrobial Chemotherapy (ISAC) (3 April 2020)

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