Telmisartan for treatment of Covid-19 patients: An open multicenter randomized clinical trial

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Abstract

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  1. SciScore for 10.1101/2020.08.04.20167205: (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 ethics committee at HCJSM and the institutional review board at HEBA.
    Consent: All the patients provided written informed consent before randomization.
    RandomizationTrial design and settings: We conducted this two-arm, multicenter, randomized, open-label, controlled trial at two academic hospitals in Ciudad de Buenos Aires, Argentina: Hospital de Clínicas “José de San Martín” or site 1 (HCJSM, University of Buenos Aires main hospital) and Hospital Español de Buenos Aires or site 2 (HEBA, a community hospital).
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Simple randomization was performed using the GraphPad QuickCalcs Web site by a statistician with no contact with patient care.
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)
    Analyses were performed using GraphPad Prism version 8.4.3 (686) for Windows.
    GraphPad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)

    Results from OddPub: Thank you for sharing your data.


    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Main limitations of the study are the lack of blinding, the exclusion of ICU patients on randomization, the low number of enrolled patients given the preliminary nature of this report, and the restriction to patients with a relatively short time from symptom onset to randomization. Therefore, additional rigorous studies are warranted to determine its value as a therapeutic tool in the Covid-19 clinical spectrum. In synthesis, the present results constitute strong evidence in favor of the involvement of the RAS in the inflammatory process observed in hospitalized Covid-19 patients and that the ARB telmisartan, a well-known inexpensive safe antihypertensive drug, administered in high doses, demonstrates anti-inflammatory effects and improved morbidity in hospitalized patients infected with SARS-CoV-2, providing support for its use in this serious pandemia.

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

    IdentifierStatusTitle
    NCT04355936CompletedTelmisartan for Treatment of COVID-19 Patients


    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.

  2. SciScore for 10.1101/2020.08.04.20167205: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementEthics The study protocol and its modifications were approved by the ethics committee of Hospital de Clínicas “José de San Martín”, Facultad de Medicina, Universidad de Buenos Aires and by the Institutional Review Board at Hospital EspañolRandomizationMethods Trial design and settings We conducted this two-arm, multicenter, randomized, open-label, controlled trial at two academic hospitals in Ciudad de Buenos Aires, Argentina: Hospital de Clínicas “José de San Martín” or site 1 (HCJSM, University of Buenos Aires main hospital) and Hospital Español de Buenos Aires or site 2 (HEBA, a community hospital).Blindingnot detected.Power Analysisnot detected.Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Simple randomization was performed using the GraphPad QuickCalcs Web site by a statistician with no contact with patient care (MVS).
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)
    Analyses were performed using GraphPad Prism version 8.4.3 (686) for Windows. Patient and Public Involvement.
    GraphPad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)

    Results from OddPub: Thank you for sharing your data.


    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

    Main limitations of the study are the lack of blinding, the exclusion of ICU patients on randomization, the low number of enrolled patients given the preliminary nature of this report, and the restriction to patients with a relatively short time from symptom onset to randomization. Therefore, additional rigorous studies are warranted to determine its value as a therapeutic tool in the Covid-19 clinical spectrum. In synthesis, the present results constitute strong evidence in favor of the involvement of the RAS in the inflammatory process observed in hospitalized Covid-19 patients and that the ARB telmisartan, a well-known inexpensive safe antihypertensive drug, administered in high doses, demonstrates anti-inflammatory effects and improved morbidity in hospitalized patients infected with SARS -CoV-2, providing support for its use in this serious pandemia.


    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.


    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.