Ozone therapy for patients with COVID-19 pneumonia: Preliminary report of a prospective case-control study

  1. Alberto Hernández
  2. Montserrat Viñals
  3. Asunción Pablos
  4. Francisco Vilás
  5. Peter J Papadakos
  6. Duminda N. Wijeysundera
  7. Sergio D. Bergese
  8. Marc Vives

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Abstract

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  1. Version published to 10.1016/j.intimp.2020.107261
  2. Version published to 10.1101/2020.06.03.20117994v4 on medRxiv
  3. Version published to 10.1101/2020.06.03.20117994v3 on medRxiv
  4. Version published to 10.1101/2020.06.03.20117994v2 on medRxiv
  5. ScreenIT

    SciScore for 10.1101/2020.06.03.20117994: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: It was conducted in compliance with the Declaration of Helsinki and approved by a multidisciplinary human research ethics committee (HREC) at the institution.
    Consent: Each participant gave written informed consent for administration of any interventions, collection of relevant clinical data and ascertainment of outcomes.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    26 Outcomes: Statistical Analysis: All analyses were performed using STATA version 13.0 (StataCorp. 2013. Stata Statistical Software:
    STATA
    suggested: (Stata, RRID:SCR_012763)
    StataCorp
    suggested: (Stata, RRID:SCR_012763)

    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:
    Limitations include the sample size of our cohort is small and single-centered. The 95% CIs for our adjusted estimates were wide, and do not exclude a 20–30% decrease in the coefficient for time (days) to clinical improvement. Outcome assessors were not blinded to the treatment arm assignment. The group who received ozonated autohemotherapy were slightly younger and had lower body mass index. However, a post-hoc sensitivity analysis adjusted for age, quick SOFA and weight was conducted and the adjusted analysis confirmed the results. Furthermore, as it was an observational study IL-6 and other cytokines could not be measured. The strengths of this study include its pragmatic real-world COVID-19 population, use of objective primary clinical outcome and risk-adjustment using methods of regression modeling analyses. In conclusion, ozonated autohemotherapy was associated with a significant shorter time to clinical improvement and shorter time to a two-fold decrease of C-reactive protein, ferritin, D-dimer and Lactate Dehydrogenase in severe COVID-19 pneumonia patients in this prospective case-control study.

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

    IdentifierStatusTitle
    NCT04444531CompletedOzone Therapy and Coronavirus Disease of 2019 (COVID-19) Pne…

    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.

    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.

  6. Version published to 10.1101/2020.06.03.20117994v1 on medRxiv