Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-30 @ 8:47 AM
Study NCT ID:
NCT04931004
Status:
UNKNOWN
Last Update Posted:
2021-06-23
First Post:
2021-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Rinse to Reduced Expelled Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) During COVID-19 Infection
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will be randomized to one of four arms. Type of mouthwash will not be disclosed to participant. Laboratory personnel and investigators performing the outcome measurements and analysis will be blinded to intervention.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-17', 'studyFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-06-16', 'lastUpdatePostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Influence of Speaking', 'timeFrame': 'Single timepoint, ~1 hour', 'description': 'Difference in viral load by face mask sampling with speaking versus not speaking'}], 'primaryOutcomes': [{'measure': 'Control Phase - Primary Endpoint', 'timeFrame': 'Single timepoint, ~1 hour', 'description': 'Reduction in viral load by face mask sampling from pre-intervention to 0-15 with CPC versus water rinse control'}, {'measure': 'Evaluation Phase - Primary Endpoint', 'timeFrame': 'Single timepoint, ~1.5 hours', 'description': 'Reduction in viral load by face mask sampling from pre-intervention to 45-60 minutes versus water rinse control'}], 'secondaryOutcomes': [{'measure': 'Evaluation Phase - Secondary Endpoint', 'timeFrame': 'Single timepoint, ~1 hour', 'description': 'Reduction in viral load by face mask sampling from pre-intervention to 0-15 and15-30 minutes of oral rinse products versus water rinse control'}, {'measure': 'Comparative Saliva Reduction', 'timeFrame': 'Single timepoint, ~1.5 hours', 'description': 'Reduction in viral load in saliva pre-intervention to 30 and 60 minutes post-intervention.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Prospective, cross-sectional study evaluating the effect of commercially available mouthwashes on expelled/exhaled SARS-CoV-2 viral load using face mask sampling.', 'detailedDescription': 'The study will consist of a Control Phase to optimize procedures for measuring expelled/exhaled viral load, and a Evaluation phase comparing different commercially available mouthwashes.\n\nIn the Control Phase. up to 20 COVID-19 patients will be asked to undergo a sequence of face mask sampling and saliva collections prior to and after an oral rinse with (i) water and (ii) a commercially-available cetylpyridinium chloride (CPC) mouthwash.\n\nBased on outcomes of the Control Phase, the study will proceed into the Evaluation Phase, which will randomize approximately 40 COVID-19 patients to receive 1 of 4 commercially available Colgate mouthwashes following standard package instructions. Face mask sampling and saliva will be collected prior to and after the mouth rinse to assess impact on SARS-CoV-2 viral load.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18\n2. Able to provide consent\n3. Polymerase chain reaction (PCR)-confirmed SARS-CoV-2 within previous 48 hours.\n\nExclusion Criteria:\n\n1. Clinical contraindication or poor feasibility to complete study procedures\n2. Unwilling or unable to produce saliva or face mask samples\n3. Unable to produce at least 500 microliters of saliva.\n4. Eaten within past 30 minutes\n5. Known allergy to mouthwash products'}, 'identificationModule': {'nctId': 'NCT04931004', 'briefTitle': 'Oral Rinse to Reduced Expelled Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) During COVID-19 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Effect of Oral Hygiene Products on Reducing Expelled/Exhaled SARS-CoV-2', 'orgStudyIdInfo': {'id': 'Pro2020003236'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.075% Cetylpyridinium Chloride', 'interventionNames': ['Drug: Mouthwash Product']}, {'type': 'EXPERIMENTAL', 'label': '1.5% Hydrogen peroxide', 'interventionNames': ['Drug: Mouthwash Product']}, {'type': 'EXPERIMENTAL', 'label': 'Chlorhexidine gluconate', 'interventionNames': ['Drug: Mouthwash Product']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Water rinse', 'description': 'Control for impact on viral load changes from mechanical rinsing', 'interventionNames': ['Other: Water rinse']}], 'interventions': [{'name': 'Mouthwash Product', 'type': 'DRUG', 'description': 'Commercially over-the-counter Colgate mouthwashes will be administered according to standard package instructions. Viral load will be measured prior to and after mouth rinse using serial face mask and saliva samples.', 'armGroupLabels': ['0.075% Cetylpyridinium Chloride', '1.5% Hydrogen peroxide', 'Chlorhexidine gluconate']}, {'name': 'Water rinse', 'type': 'OTHER', 'description': '30-second water rinse will occur in the control group. Viral load will be measured prior to and after water rinse using serial face mask and saliva samples.', 'armGroupLabels': ['Water rinse']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yingda L Xie, MD', 'role': 'CONTACT', 'email': 'yingda.xie@rutgers.edu', 'phone': '9739722246'}, {'name': 'David Alland, MD', 'role': 'CONTACT', 'email': 'allandda@njms.rutgers.edu'}], 'overallOfficials': [{'name': 'Yingda L Xie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers University'}, {'name': 'David Alland, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers University'}, {'name': 'Padmapriya Banada, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Beginning 3 months and ending 5 years following article publication', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)', 'accessCriteria': 'Researchers who provide a methodologically sound proposal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, {'name': 'University of Leicester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yingda Linda Xie, MD', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}