Study comparing hydroxychloroquine and antiviral drug for COVID-19 retracted

The authors of a study comparing hydroxychloroquine and the antiviral agent favipiravir as treatments for COVID-19 have lost the paper after post-publication peer review determined that the data did not support the conclusions. 

Safety and efficacy of favipiravir versus hydroxychloroquine in management of COVID-19: A randomised controlled trial” appeared in March in Scientific Reports, a Nature title. The authors, from institutions in Egypt, reported that: 

Favipiravir is considered a potential treatment for COVID-19 due its efficacy against different viral infections. We aimed to explore the safety and efficacy of favipiravir in treatment of COVID-19 mild and moderate cases. It was randomized-controlled open-label interventional phase 3 clinical trial [NCT04349241]. 100 patients were recruited from 18th April till 18th May. 50 patients received favipiravir 3200 mg at day 1 followed by 600 mg twice (day 2–day 10). 50 patients received hydroxychloroquine 800 mg at day 1 followed by 200 mg twice (day 2–10) and oral oseltamivir 75 mg/12 h/day for 10 days. Patients were enrolled from Ain Shams University Hospital and Assiut University Hospital. Both arms were comparable as regards demographic characteristics and comorbidities. The average onset of SARS-CoV-2 PCR negativity was 8.1 and 8.3 days in HCQ-arm and favipiravir-arm respectively. 55.1% of those on HCQ-arm turned PCR negative at/or before 7th day from diagnosis compared to 48% in favipiravir-arm (p = 0.7). 4 patients in FVP arm developed transient transaminitis on the other hand heartburn and nausea were reported in about 20 patients in HCQ-arm. Only one patient in HCQ-arm died after developing acute myocarditis resulted in acute heart failure. Favipiravir is a safe effective alternative for hydroxychloroquine in mild or moderate COVID-19 infected patients.

Perhaps that’s true — but this study can’t make the case. According to the retraction notice

After concerns were brought to the Editors’ attention after publication, the raw data underlying the study were requested. The authors provided several versions of their dataset. Post-publication peer review confirmed that none of these versions fully recapitulates the results presented in the cohort background comparisons, casting doubt on the reliability of the data. Additional concerns were raised about the randomisation procedure, as the equal distribution of male and female patients is unlikely unless sex is a parameter considered during randomisation. However, based on the clarification provided by the authors, sex was not considered during this process. The Editors therefore no longer have confidence in the results and conclusions presented.

Hany M. Dabbous, Manal H. El-Sayed, Gihan El Assal, Hesham Elghazaly, Fatma F. S. Ebeid, Ahmed F. Sherief, Maha Elgaafary, Ehab Fawzy, Sahar M. Hassany, and Ahmed R. Riad disagree with the retraction. Mohamed A. TagelDin did not respond to the correspondence from the Editors about the retraction.

The article has been cited five times, according to Clarivate Analytics’ Web of Science.

Meanwhile, White’s journal may want to take a closer look at this meta-analysis, which it published in May. The article cites the Dabbous paper as one of nine clinical trials of favipiravir as a treatment for COVID-19.

Dabbous did not respond to a request for comment. Richard White, the chief editor of Scientific Reports, referred our request for comment to Springer Nature corporate. A spokesperson for the publisher told us: 

After publication of the paper, concerns were raised by a reader, which prompted us to request the raw data underlying the study. Our subsequent investigation, which included post-publication peer review, identified concerns in relation to the underlying data and randomization and the editors decided that the most appropriate course of action was to retract. Concerns regarding the other paper you mentioned are currently under investigation by the Scientific Reports editorial team.

The latest removal brings the number of COVID-19 retractions to 159, by our count.

Hat tip: Nick Brown

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10 thoughts on “Study comparing hydroxychloroquine and antiviral drug for COVID-19 retracted”

  1. Is it just me that thinks the number of retractions from the journal Scientific Reports worrying? and a black mark against the Nature brand.

    1. The Nature journals have joined the rest of the crappy Springer journals since they were acquired. Sci Rep in particular would be a great candidate for Beall’s List (RIP) if the list still existed. It’s basically pay for play with the Nature name attached.

      1. Scientific Reports appears to have a good reputation as many prominent researchers around the world are publishing in this journal. What could be the issue you are highlighting here? Please provide some examples of “Crappy” Springer journals you mentioned so that readers are aware of them.

    1. Can you elaborate why?
      The reason given for retraction – that the author could not provide any dataset matching their results – sound pretty valid to me.

      1. Exactly. If a baseball scout recommended signing a player that he said hit .300 but the data showed .200 then the scout would get fired.

  2. Being as effective as hydroychloroquine for treatment of COVID-19 doesn’t seem to be much of a claim.
    That means it is about as effective as Kool-Aid.

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