RETRACTED: Effect of early treatment with metformin on risk of emergency care and hospitalization among patients with COVID-19: The TOGETHER randomized platform clinical trial

  1. Gilmar Reis
  2. Eduardo Augusto dos Santos Moreira Silva
  3. Daniela Carla Medeiros Silva
  4. Lehana Thabane
  5. Aline Cruz Milagres
  6. Thiago Santiago Ferreira
  7. Castilho Vitor Quirino dos Santos
  8. Adhemar Dias de Figueiredo Neto
  9. Eduardo Diniz Callegari
  10. Leonardo Cançado Monteiro Savassi
  11. Maria Izabel Campos Simplicio
  12. Luciene Barra Ribeiro
  13. Rosemary Oliveira
  14. Ofir Harari
  15. Holly Bailey
  16. Jamie I Forrest
  17. Alla Glushchenko
  18. Sheila Sprague
  19. Paula McKay
  20. Craig R. Rayner
  21. Hinda Ruton
  22. Gordon H. Guyatt
  23. Edward J. Mills

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Abstract

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  1. Version published to 10.1016/j.lana.2021.100142
  2. ScreenIT

    SciScore for 10.1101/2021.08.19.21262323: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsIRB: The trial, which complied with the International Conference of Harmonization – Good Clinical Practices, as well as local regulatory requirements, was approved for research ethics by local and national ethics boards in Brazil (CONEP CAAE: 41174620.0.1001.5120, approval letter 5.501.284) and the Hamilton Integrated Research Ethics Board (
    Consent: If a patient met the above eligibility criteria, study personnel obtained written informed consent.
    Sex as a biological variableAfter obtaining informed consent a rapid antigen test for COVID-19 (Panbio ®, Abbott laboratories) and a pregnancy test for women of childbearing age were performed.
    RandomizationStudy design and oversight: The TOGETHER Trial is a randomized adaptive platform trial to investigate the efficacy of repurposed treatments for COVID-19 disease among high-risk adult outpatients.
    BlindingThe trial team, site staff and patients were blinded to treatment allocation.
    Power AnalysisStatistical Analyses: The Adaptive Design Protocol and the Master Statistical Analysis Plan provide details of sample size calculation and statistical analysis (appended).

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    After obtaining informed consent a rapid antigen test for COVID-19 (Panbio ®, Abbott laboratories) and a pregnancy test for women of childbearing age were performed.
    Abbott
    suggested: (Abbott, RRID:SCR_010477)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Strengths and limitations: Since the start of the COVID-19 pandemic, there have been more than 2800 RCTs registered on clinicaltrials.gov. However, less than 300 have been reported and the vast majority of clinical trials have been small and underpowered, with sample sizes less than 100. In many cases, these trials have been unsuccessful at recruiting as the local epidemics occur in waves and sustainable infrastructure to maintain staff or local interest for recruitment is lacking. The trials that provide the clearest medical understanding tend to be the larger platform trials, such as SOLIDARITY,16 RECOVERY,17 PRINCIPLE,11 and REMAP-CAP.18 As a result, we actively collaborate with other investigators running trials with overlapping interventions so that they can be aware of our study decisions and determine whether they should influence their respective trials. Major strengths include the rapid recruitment and enrolment of high-risk patients for the development of severe COVID-19. Our recruitment strategy involves the engagement with the local public health system, thus allowing recruitment that frequently exceeds twenty patients per day. We enrolled only participants with diagnosed COVID-19 and less than 7 days of symptom onset using a commercially available COVID-19 AG rapid test (Panbio ®). The concordance of COVID-19 positive tests with RT-PCR was evaluated on the group of participants with PCR evaluations and found a concordance rate of > 99% on both tests collected at ...

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04727424RecruitingRepurposed Approved and Under Development Therapies for Pati…

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2021.08.19.21262323 on medRxiv