Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Postexposure Prophylaxis of COVID-19 in Hospital Personnel Dedicated to Patients Care with COVID-19 Disease

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Abstract

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  1. SciScore for 10.1101/2021.04.13.21255409: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: This trial was approved by the institutional review board and by the ethics committees of each participating center, and participants provided written consent prior to participation.
    Consent: This trial was approved by the institutional review board and by the ethics committees of each participating center, and participants provided written consent prior to participation.
    RandomizationStudy design and participants: We conducted a pragmatic randomized, placebo-controlled clinical trial to determine if a nasal spray with Iota-Carrageenan can prevent COVID-19 infection in healthcare workers caring for COVID-19 patients.
    BlindingThe assignments were concealed from investigators and participants (double blind).
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Additionally, medical personnel under suspicion of COVID-19, COVID-19 history or with COVID-19 antibodies found in a previous routine screening were deemed uneligible to participate in this study.
    COVID-19
    suggested: None

    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 have some limitations. First, we included apparently healthy individuals without confirmation by PCR test. Second, those who remained asymptomatic were also not tested. Third, we do not know the exposure dose of each participant, although, the number of active principle and placebos administered in each participating center were identical. The devastating urgency of the COVID-19 pandemic requires a simple and pragmatic design trial with the ability to give, in this context, a quick and efficient answer. This is particularly important considering that health providers are overworked and extremely busy, and a higher burden associated with completing numerous data would have resulted in low study compliance. Our study has also a number of strengths. First, we chose healthcare and other hospital workers to participate in this research as a simple and easy-to-follow model. Second, enrollment took place during a high rate of community transmission in Argentina, therefore, our participants were also exposed outside the hospital. Third, and following the pragmatic nature of this randomized controlled clinical trial and according to the regulations established by the Nation Ministry of Health, we performed only one PCR test between 48 and 72 hours after the onset of symptoms, assuming that a negative first test may not have been enough, nor we have carried out antibody dosages to confirm the disease. Finally, a small number of individuals were lost to follow up (6.8%). In se...

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

    IdentifierStatusTitle
    NCT04521322RecruitingEfficacy of a Nasal Spray Containing Iota-Carrageenan in the…


    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.