Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-25 @ 6:02 PM
Study NCT ID:
NCT04352959
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2020-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-10', 'studyFirstSubmitDate': '2020-04-15', 'studyFirstSubmitQcDate': '2020-04-17', 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline amount of SARS-CoV-2 in salivary samples at 7 days', 'timeFrame': '7 days', 'description': 'Quantitative PCR experiments will be performed and a quantitative analysis of the salivary samples will be made'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline amount of SARS-CoV-2 virus in nasal samples at 7 days', 'timeFrame': '7 days', 'description': 'Quantitative PCR experiments will be performed and a quantitative analysis of the nasal samples will be made'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid19', 'SARS-CoV-2', 'mouthrinses', 'antiviral', 'bêta-cyclodextrin', 'citrox'], 'conditions': ['COVID19', 'Mouthwash', 'Saliva']}, 'referencesModule': {'references': [{'pmid': '32326426', 'type': 'BACKGROUND', 'citation': 'Carrouel F, Conte MP, Fisher J, Goncalves LS, Dussart C, Llodra JC, Bourgeois D. COVID-19: A Recommendation to Examine the Effect of Mouthrinses with beta-Cyclodextrin Combined with Citrox in Preventing Infection and Progression. J Clin Med. 2020 Apr 15;9(4):1126. doi: 10.3390/jcm9041126.'}, {'pmid': '33089717', 'type': 'BACKGROUND', 'citation': 'Carrouel F, Goncalves LS, Conte MP, Campus G, Fisher J, Fraticelli L, Gadea-Deschamps E, Ottolenghi L, Bourgeois D. Antiviral Activity of Reagents in Mouth Rinses against SARS-CoV-2. J Dent Res. 2021 Feb;100(2):124-132. doi: 10.1177/0022034520967933. Epub 2020 Oct 22.'}, {'pmid': '33138848', 'type': 'DERIVED', 'citation': 'Carrouel F, Viennot S, Valette M, Cohen JM, Dussart C, Bourgeois D. Salivary and Nasal Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses (BBCovid): A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Nov 2;21(1):906. doi: 10.1186/s13063-020-04846-6.'}, {'pmid': '32936948', 'type': 'DERIVED', 'citation': 'Burton MJ, Clarkson JE, Goulao B, Glenny AM, McBain AJ, Schilder AG, Webster KE, Worthington HV. Antimicrobial mouthwashes (gargling) and nasal sprays administered to patients with suspected or confirmed COVID-19 infection to improve patient outcomes and to protect healthcare workers treating them. Cochrane Database Syst Rev. 2020 Sep 16;9(9):CD013627. doi: 10.1002/14651858.CD013627.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Given the current lack of effective COVID-19 treatment, it is necessary to explore alternative methods to contain the spread of the infection, focusing in particular on its mode of transmission. The modes of person-to-person transmission of SARS-CoV-2 are direct transmission, such as sneezing, coughing, transmission through inhalation of small droplets, and transmission through contact, such as contact with nasal, oral and eye mucous membranes. SARS-CoV-2 can also be transmitted directly or indirectly through saliva. The use of antiviral mouthrinses may be used as adjunctive therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Covid-19 infection by the patient's general practitioner and hospital doctor\n* Clinical signs started less than 8 days ago.\n* Virological confirmation\n* Understanding and acceptance of the trial.\n* Written agreement to participate in the trial\n\nExclusion Criteria:\n\n* Pregnancy\n* Breastfeeding\n* Inability to comply with protocol\n* Lack of written agreement"}, 'identificationModule': {'nctId': 'NCT04352959', 'acronym': 'BBCovid', 'briefTitle': 'COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses', 'organization': {'class': 'OTHER', 'fullName': 'Claude Bernard University'}, 'officialTitle': 'COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses: Double-blind, Randomized, Placebo-controlled Clinical Study', 'orgStudyIdInfo': {'id': 'BBCovid'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'mouth rinse with antiviral', 'interventionNames': ['Device: mouthrinse with bêta-cyclodextrin and citrox']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'mouth rinse without antiviral', 'interventionNames': ['Device: mouthrinse without bêta-cyclodextrin and citrox']}], 'interventions': [{'name': 'mouthrinse with bêta-cyclodextrin and citrox', 'type': 'DEVICE', 'description': '3 daily mouthrinses for 7 days', 'armGroupLabels': ['mouth rinse with antiviral']}, {'name': 'mouthrinse without bêta-cyclodextrin and citrox', 'type': 'DEVICE', 'description': '3 daily mouthrinses for 7 days', 'armGroupLabels': ['mouth rinse without antiviral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69300', 'city': 'Caluire-et-Cuire', 'country': 'France', 'facility': 'Clinic of the Protestant Infirmary in Lyon', 'geoPoint': {'lat': 45.79462, 'lon': 4.8464}}, {'zip': '43000', 'city': 'Le Puy-en-Velay', 'country': 'France', 'facility': 'Hospital Center Emile Roux', 'geoPoint': {'lat': 45.04366, 'lon': 3.88523}}, {'zip': '69007', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospital Center Saint Luc Saint Joseph', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '40000', 'city': 'Mont-de-Marsan', 'country': 'France', 'facility': 'Intercommunal Hospital Center of Mont de Marsan', 'geoPoint': {'lat': 43.89022, 'lon': -0.49713}}], 'overallOfficials': [{'name': 'Florence Carrouel, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Claude Bernard Lyon 1'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Claude Bernard University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Carrouel Florence', 'investigatorAffiliation': 'Claude Bernard University'}}}}