Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT05777720
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-15
First Post:
2023-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cluster-Randomized Trial of Air Filtration and Ventilation to Reduce Covid19 Spread in Homes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2023-03-18', 'studyFirstSubmitQcDate': '2023-03-18', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Covid19', 'timeFrame': '7th day since enrollment in the trial', 'description': 'Investigators will measure the incidence of Covid19 in susceptible contacts on day 7.'}], 'secondaryOutcomes': [{'measure': 'Incidence of new upper respiratory symptoms', 'timeFrame': '7th day since enrollment in the trial', 'description': 'Investigators will measure reported new upper respiratory symptoms in susceptible contacts.'}, {'measure': 'Average CO2 levels', 'timeFrame': '7 days', 'description': 'Investigators will measure 7 day average CO2 levels in the home (measured in parts per million)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ventilation', 'air filtration', 'Covid19', 'SARS CoV 2', 'household transmission'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Investigators are evaluating whether an intervention consisting of box-fans with MERV 16 filters ("filtration fans") and recommendations for improving ventilation in the home can reduce secondary spread of Covid19 from an index case to susceptible contacts within the home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Household members live in a shared space (apartment, home) with others (as opposed to renting single rooms in a shared space, for example)\n* At least 3 other people live in the household aside from index case\n\nExclusion Criteria:\n\n* If index case test positive day was over 2 days prior\n* If half or more household members are thought to be infected already\n* If household has fewer than 3 contacts interested in participating in the study\n* If fewer than 3 contacts are expected to be present in the house for a majority of the following 7 days'}, 'identificationModule': {'nctId': 'NCT05777720', 'briefTitle': 'Cluster-Randomized Trial of Air Filtration and Ventilation to Reduce Covid19 Spread in Homes', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Cluster-randomized Controlled Trial of Air Filtration and Ventilation Improvements to Reduce SARS CoV 2 Transmission Among Household Contacts', 'orgStudyIdInfo': {'id': '55479'}, 'secondaryIdInfos': [{'id': '5T32AI052073-17', 'link': 'https://reporter.nih.gov/quickSearch/5T32AI052073-17', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention will be administered in this arm. Investigators will give families a CO2 monitor to measure average CO2 levels in the home. Investigators will provide a link to the basic CDC isolation guidelines which would be part of standard of care. Investigators will test family members at day 0-1 for baseline testing; and again on day 7 for assessing secondary transmission among susceptible contacts.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Families are provided with one filtration fan unit per room in their home (and one for the index case; if the family lives in a studio, they would receive 2 units). Investigators will advise families on ventilation improvements in their home. Investigators will provide an instructional pamphlet that describes how the fans work and the importance of ventilation. Investigators will follow-up on day 3-4 to check in and run through a checklist to ensure the fans are working and ventilation improvements are being attempted. Investigators will give families a CO2 monitor to measure average CO2 levels in the home. Investigators will test family members at day 0-1 for baseline testing; and again on day 7 for assessing secondary transmission among susceptible contacts.', 'interventionNames': ['Device: Filtration Fan', 'Behavioral: Safe-home pamphlet', 'Behavioral: Mid-week phone call']}], 'interventions': [{'name': 'Filtration Fan', 'type': 'DEVICE', 'description': 'Investigators are using box fans with attached MERV16 filters, a design that has been tested and published in the scientific literature.', 'armGroupLabels': ['Intervention']}, {'name': 'Safe-home pamphlet', 'type': 'BEHAVIORAL', 'description': 'The pamphlet has information on how the filtration fans work through visual images; and images of ventilation improvements in the home through opening windows.', 'armGroupLabels': ['Intervention']}, {'name': 'Mid-week phone call', 'type': 'BEHAVIORAL', 'description': 'On day 3-4 of the study, the study coordinator assigned to the house will call and check in regarding the filtration fan usage and remind families about the importance of filtration and ventilation.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94403', 'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'facility': 'San Mateo Medical Center', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Yvonne Maldonado, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Stanford University'}, {'name': 'Abraar Karan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post-Doctoral Fellow', 'investigatorFullName': 'Abraar Karan', 'investigatorAffiliation': 'Stanford University'}}}}