<?xml version="1.0" encoding="UTF-8"?>
<codeBook xmlns="ddi:codebook:2_5" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:xs="http://www.w3.org/2001/XMLSchema" xsi:schemaLocation="ddi:codebook:2_5         http://www.ddialliance.org/Specification/DDI-Codebook/2.5/XMLSchema/codebook.xsd">
  <docDscr>
    <citation>
      <titlStmt>
        <titl xml:lang="FR">Effet de bains de bouche sur la charge virale salivaire de SARS-CoV-2</titl>
        <subTitl/>
        <altTitl xml:lang="FR">BBCovid</altTitl>
        <altTitl xml:lang="EN">BBCovid</altTitl>
        <parTitl xml:lang="EN">Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses</parTitl>
        <IDNo>PEF73441</IDNo>
      </titlStmt>
      <rspStmt>
        <AuthEnty affiliation="ITMO Santé Publique, Aviesan">Portail Épidémiologie-France</AuthEnty>
        <othId/>
      </rspStmt>
      <prodStmt>
        <producer abbr="PEF-HD" affiliation="ITMO Santé Publique, Aviesan">Portail Épidémiologie-France | Health Databases</producer>
        <copyright>Portail Épidémiologie-France 2026</copyright>
        <prodDate date="2026-04-06">06/04/2026</prodDate>
        <prodPlac>https://epidemiologie-france.aviesan.fr/</prodPlac>
        <software/>
        <fundAg/>
        <grantNo/>
      </prodStmt>
      <distStmt>
        <distrbtr>Portail Épidémiologie-France</distrbtr>
        <contact email="portail-epidemiologie@inserm.fr">Portail Epidemiologie-France</contact>
        <depositr>Florence Carrouel</depositr>
        <depDate xml:lang="FR">12/11/2020</depDate>
        <depDate xml:lang="EN">06/01/2021</depDate>
        <distDate>20/06/2025</distDate>
      </distStmt>
      <serStmt>
        <serInfo/>
      </serStmt>
      <verStmt>
        <version xml:lang="FR" date="20/06/2025">2</version>
        <version xml:lang="EN" date="08/01/2021">1</version>
        <verResp>Florence Carrouel</verResp>
        <notes/>
      </verStmt>
      <biblCit/>
      <holdings xml:lang="FR" location="Portail Epidemiologie-France" URI="http://admin-epid-prod2.inserm.fr/en/layout/set/print/content/view/full/90145">BBCovid - Effet de bains de bouche sur la charge virale salivaire de SARS-CoV-2</holdings>
      <holdings xml:lang="EN" location="Portail Epidemiologie-France" URI="http://admin-epid-prod2.inserm.fr/en/layout/set/print/content/view/full/90160">BBCovid - Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses</holdings>
      <notes/>
    </citation>
    <guide/>
    <docStatus/>
    <notes/>
  </docDscr>
  <stdyDscr>
    <citation>
      <titlStmt>
        <titl xml:lang="FR">Effet de bains de bouche sur la charge virale salivaire de SARS-CoV-2</titl>
        <subTitl/>
        <altTitl xml:lang="FR">BBCovid</altTitl>
        <altTitl xml:lang="EN">BBCovid</altTitl>
        <parTitl xml:lang="EN">Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses</parTitl>
        <IDNo/>
      </titlStmt>
      <rspStmt>
        <AuthEnty affiliation="University Lyon 1">Florence CARROUEL</AuthEnty>
      </rspStmt>
      <prodStmt>
        <producer role="Public">Laboratory "Systemic Health Course", EA4129</producer>
        <copyright/>
        <prodDate/>
        <prodPlac>Laboratory "Systemic Health Course", EA4129 - University Lyon 1 - Laboratory "Systemic Health Course", EA4129
Faculty of Medicine Laennec,
11 Rue Guillaume Paradin,
69372 LYON CEDEX 08
FRANCE</prodPlac>
        <software/>
        <fundAg xml:lang="FR" role=""/>
        <fundAg xml:lang="EN" role=""/>
        <grantNo/>
      </prodStmt>
      <distStmt>
        <distrbtr>University Lyon 1</distrbtr>
        <contact affiliation="University Lyon 1" email="florence.carrouel@univ-lyon1.fr">Florence CARROUEL</contact>
        <depositr>Florence Carrouel</depositr>
        <depDate xml:lang="FR">12/11/2020</depDate>
        <depDate xml:lang="EN">06/01/2021</depDate>
        <distDate xml:lang="FR">20/06/2025</distDate>
        <distDate xml:lang="EN">08/01/2021</distDate>
      </distStmt>
      <serStmt>
        <serName/>
        <serInfo/>
      </serStmt>
      <verStmt>
        <version xml:lang="FR" date="20/06/2025">2</version>
        <version xml:lang="EN" date="08/01/2021">1</version>
        <verResp>Florence Carrouel</verResp>
        <notes/>
      </verStmt>
      <biblCit/>
      <holdings/>
      <notes/>
    </citation>
    <studyAuthorization>
      <authorizingAgency>CNIL</authorizingAgency>
      <authorizationStatement xml:lang="FR">CPP 2020.04.11 sept _20.04.06.46640, CNIL 2217601 v 0, ClinicalTrials.gov ID: NCT04352959</authorizationStatement>
      <authorizationStatement xml:lang="EN">CPP 2020.04.11 sept _20.04.06.46640, CNIL 2217601 v 0, ClinicalTrials.gov ID: NCT04352959</authorizationStatement>
    </studyAuthorization>
    <stdyInfo>
      <studyBudget/>
      <subject>
        <keyword xml:lang="FR"/>
        <keyword xml:lang="EN"/>
        <topcClas xml:lang="FR">Maladies infectieuses</topcClas>
        <topcClas xml:lang="EN">Infectious diseases</topcClas>
        <topcClas xml:lang="FR"/>
        <topcClas xml:lang="EN"/>
      </subject>
      <abstract xml:lang="FR">Objectif de la base de données : Décrire l’évolution de la charge virale nasale et salivaire chez des patients probablement&#13;
infectés par le Covid-19, effectuant pendant 7 jours des bains de bouche avec et sans&#13;
antiviraux.</abstract>
      <abstract xml:lang="EN">Database objective : Change from Baseline amount of SARS-CoV-2 in salivary samples at 7 days&#13;
Quantitative PCR experiments will be performed and a quantitative analysis of the salivary samples will be made</abstract>
      <sumDscr>
        <timePrd/>
        <collDate event="start">2020</collDate>
        <collDate event="end">2020</collDate>
        <collDate xml:lang="FR">Collecte des données terminée</collDate>
        <collDate xml:lang="EN">Data collection completed</collDate>
        <nation>France</nation>
        <geogCover xml:lang="FR"/>
        <geogCover xml:lang="EN"/>
        <geogUnit>National</geogUnit>
        <anlyUnit xml:lang="fr">individuel
                </anlyUnit>
        <anlyUnit xml:lang="en">individuals
                </anlyUnit>
        <universe xml:lang="FR" clusion="I">Age : 18 ans  70 ans.&#13;
Diagnostic clinique d’infection Covid-19 par le médecin généraliste et hospitalier du patient&#13;
Début des signes cliniques depuis moins de 48 heures.&#13;
Confirmation virologique : pas nécessaire mais possible.&#13;
Compréhension et acceptation de l’essai.&#13;
Accord écrit de participation à l’essai</universe>
        <universe xml:lang="EN" clusion="I">• Age: 18-70 years&#13;
• Clinical diagnosis of Covid-19 infection by the patient's general practitioner and hospital doctor&#13;
• Clinical signs started less than 48 hours ago.&#13;
• Virological confirmation: not necessary but possible.&#13;
• Understanding and acceptance of the trial.&#13;
• Written agreement to participate in the trial</universe>
        <universe xml:lang="FR">Nombre d'individus : 175</universe>
        <universe xml:lang="EN">Number of individuals: </universe>
        <universe xml:lang="FR" level="Tranche d'âge">Adolescence (13 à 18 ans)</universe>
        <universe xml:lang="FR" level="Tranche d'âge">Adulte (19 à 24 ans)</universe>
        <universe xml:lang="FR" level="Tranche d'âge">Adulte (25 à 44 ans)</universe>
        <universe xml:lang="FR" level="Tranche d'âge">Adulte (45 à 64 ans)</universe>
        <universe xml:lang="FR" level="Tranche d'âge">Personnes âgées (65 à 79 ans)</universe>
        <universe xml:lang="EN" level="Age range">Adolescence (13 to 18 years)</universe>
        <universe xml:lang="EN" level="Age range">Adulthood (19 to 24 years)</universe>
        <universe xml:lang="EN" level="Age range">Adulthood (25 to 44 years)</universe>
        <universe xml:lang="EN" level="Age range">Adulthood (45 to 64 years)</universe>
        <universe xml:lang="EN" level="Age range">Elderly (65 to 79 years)</universe>
        <universe xml:lang="FR" level="Type de population">Sujets malades</universe>
        <universe xml:lang="EN" level="Population type">Sick population</universe>
        <universe xml:lang="FR" level="Pathologie">I - Certaines maladies infectieuses et parasitaires</universe>
        <universe xml:lang="EN" level="Pathology">I - Certain infectious and parasitic diseases</universe>
        <universe xml:lang="FR" level="Sexe">Masculin</universe>
        <universe xml:lang="FR" level="Sexe">Féminin</universe>
        <universe xml:lang="EN" level="Sex">Male</universe>
        <universe xml:lang="EN" level="Sex">Female</universe>
        <dataKind xml:lang="FR">Autres</dataKind>
        <dataKind xml:lang="EN">Others</dataKind>
        <dataKind xml:lang="FR"/>
        <dataKind xml:lang="EN"/>
        <dataKind xml:lang="FR">Données cliniques : </dataKind>
        <dataKind xml:lang="FR">Données biologiques : </dataKind>
        <dataKind xml:lang="EN">Clinical data: </dataKind>
        <dataKind xml:lang="EN">Biological data: </dataKind>
        <dataKind xml:lang="FR"/>
        <dataKind xml:lang="EN"/>
        <dataKind xml:lang="FR"/>
        <dataKind xml:lang="EN"/>
      </sumDscr>
      <qualityStatement>
        <standardsCompliance>
          <standard>
            <standardName/>
            <producer/>
          </standard>
          <complianceDescription/>
        </standardsCompliance>
        <otherQualityStatement xml:lang="FR"/>
        <otherQualityStatement xml:lang="EN"/>
        <otherQualityStatement xml:lang="FR"/>
        <otherQualityStatement xml:lang="EN"/>
      </qualityStatement>
      <notes/>
      <exPostEvaluation>
        <evaluator/>
        <evaluationProcess/>
        <outcomes/>
      </exPostEvaluation>
    </stdyInfo>
    <studyDevelopment>
      <developmentActivity>
        <description/>
        <participant/>
        <resource>
          <dataSrc/>
          <dataSrc/>
          <dataSrc/>
          <dataSrc/>
          <srcOrig/>
          <srcChar/>
          <srcDocu/>
        </resource>
        <outcome/>
      </developmentActivity>
    </studyDevelopment>
    <method>
      <dataColl>
        <dataCollector affiliation="University Lyon 1">Florence CARROUEL</dataCollector>
        <collectorTraining/>
        <sampProc xml:lang="FR"/>
        <sampProc xml:lang="EN"/>
        <deviat/>
        <collMode xml:lang="FR">eCRF</collMode>
        <collMode xml:lang="FR">Examen médical : </collMode>
        <collMode xml:lang="EN">Medical registration: </collMode>
        <collMode xml:lang="FR"/>
        <collMode xml:lang="EN"/>
        <collMode xml:lang="FR"/>
        <collMode xml:lang="EN"/>
        <resInstru/>
        <instrumentDevelopment/>
        <sources>
          <dataSrc/>
          <srcOrig/>
          <srcChar/>
          <srcDocu/>
        </sources>
        <collSitu/>
        <actMin/>
        <ConOps/>
        <weight/>
        <cleanOps/>
      </dataColl>
      <notes/>
      <anlyInfo>
        <respRate/>
        <EstSmpErr/>
        <dataAppr/>
      </anlyInfo>
      <stdyClas/>
      <dataProcessing/>
      <codingInstructions>
        <txt/>
        <command/>
      </codingInstructions>
    </method>
    <dataAccs>
      <setAvail>
        <accsPlac/>
        <origArch/>
        <avlStatus xml:lang="FR"/>
        <avlStatus xml:lang="EN"/>
        <collSize/>
        <complete/>
        <fileQnty/>
        <notes/>
      </setAvail>
      <useStmt>
        <confDec/>
        <specPerm/>
        <restrctn xml:lang="FR"/>
        <restrctn xml:lang="EN"/>
        <contact/>
        <citReq/>
        <deposReq/>
        <conditions xml:lang="FR"/>
        <conditions xml:lang="EN"/>
        <disclaimer/>
      </useStmt>
      <notes/>
    </dataAccs>
    <othrStdyMat>
      <relMat xml:lang="FR"/>
      <relMat xml:lang="FR"/>
      <relStdy/>
      <relPubl xml:lang="FR">http://admin-epid-prod2.inserm.fr/en/layout/set/print/content/download/106727/4014187/version/1/file/Carrouel et al CMI 2021.pdf</relPubl>
      <relPubl xml:lang="FR">http://admin-epid-prod2.inserm.fr/en/layout/set/print/content/download/106728/4014192/version/1/file/Carrouel et al Trial 2020.pdf</relPubl>
      <relPubl xml:lang="FR">http://admin-epid-prod2.inserm.fr/en/layout/set/print/content/download/106729/4014197/version/1/file/Carrouel et al viruses 2021.pdf</relPubl>
      <relPubl xml:lang="EN">http://admin-epid-prod2.inserm.fr/en/layout/set/print/content/download/100602/3901260/version/1/file/Carrouel et al Trial 2020.pdf</relPubl>
      <othRefs xml:lang="FR"/>
      <othRefs xml:lang="EN"/>
    </othrStdyMat>
    <notes/>
  </stdyDscr>
</codeBook>
