Efficacy of Brazilian green propolis (EPP-AF®) as an adjunct treatment for hospitalized COVID-19 patients: A randomized, controlled clinical trial

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Abstract

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  1. SciScore for 10.1101/2021.01.08.20248932: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The protocol was approved by the Brazilian Committee of Ethics in Human Research (Registration number 31099320.6.0000.0048), and the trial was registered (ClinicalTrials.gov number, NCT04480593).
    Consent: All participating patients and/or legal representatives were informed about the objectives and risks of participation and gave written informed consent.
    RandomizationTrial Design and Oversight: Bee-Covid was a single-center, open-label, randomized, controlled trial conducted from June 3 through August 30, 2020, at São Rafael Hospital, Salvador, Bahia, in northeast Brazil.
    Blindingnot detected.
    Power AnalysisBased on a two-sided type I error of 0.05 and 80% power to identify a difference of four days of length of hospital stay between the lower dose and the control groups, a sample size of 42 patients by group would be needed.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Analyses were performed with R software, version 4.0.2 (R Project for Statistical Computing).
    R Project for Statistical
    suggested: (R Project for Statistical Computing, RRID:SCR_001905)

    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:
    Our study has several limitations. It was a single center clinical trial, requiring greater caution in interpretations and generalizations concerning the findings. Although we blinded most of the health professionals involved in care of the patients, to reduce the possibility of interference, this trial was open. Also, the patients were followed for only a short period, limiting the possibility of evaluating long-term effects. In conclusion, the addition of oral propolis to the standard care procedures was safe and had clinical benefits for the hospitalized COVID-19 patients, especially evidenced by a reduction in the hospitalization time. Possibly, administration early in the disease course would have an even greater effect in reducing the disease’s impact. Given our findings, and the evidence concerning the ways in which propolis can affect various disease mechanisms that are relevant to SARS-CoV-2 infection, propolis should be considered as an adjuvant in the treatment of COVID-19 patients. Future studies to further assess the impact of propolis on renal protection would be useful.

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

    IdentifierStatusTitle
    NCT04480593CompletedThe Use of Brazilian Green Propolis Extract (EPP-AF) in 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.

    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.