Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-31 @ 2:00 AM
Study NCT ID:
NCT04471766
Status:
UNKNOWN
Last Update Posted:
2021-10-13
First Post:
2020-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Locally Produced Cloth Face Mask and COVID-19 Like Illness Prevention
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-21', 'size': 436876, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-21T03:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2020-07-14', 'studyFirstSubmitQcDate': '2020-07-14', 'lastUpdatePostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reported COVID-like illness', 'timeFrame': 'Four months follow-up', 'description': 'Self-reported main symptoms of COVID-19 (three or more - fever, cough, fatigue, shortness of breath, loss of smell / taste)'}, {'measure': 'Consultation', 'timeFrame': 'Four months follow-up', 'description': 'Consultation for COVID-19 like illness or/and reported positive test'}, {'measure': 'Severe illness', 'timeFrame': 'Four months follow-up', 'description': 'Self reported COVID-19 like illness plus hospitalization or death'}, {'measure': 'Mortality', 'timeFrame': 'Four months follow-up', 'description': 'Any death during the follow-up period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Face mask', 'COVID-19', 'Respiratory illness', 'Mortality'], 'conditions': ['COVID-19', 'Respiratory Illness']}, 'referencesModule': {'references': [{'pmid': '38349910', 'type': 'DERIVED', 'citation': 'Nanque LM, Jensen AM, Diness A, Nielsen S, Cabral C, Cawthorne D, Martins JSD, Ca EJC, Jensen K, Martins CL, Rodrigues A, Fisker AB. Effect of distributing locally produced cloth facemasks on COVID-19-like illness and all-cause mortality-a cluster-randomised controlled trial in urban Guinea-Bissau. PLOS Glob Public Health. 2024 Feb 13;4(2):e0002901. doi: 10.1371/journal.pgph.0002901. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': "The number of cases of COVID-19 is still increasing and transmission of SARS-CoV-2 seems to occur mainly through person-to-person transmission through respiratory droplets, indirect contact with infected people and surfaces. The use of face masks is recommended as a public health measure, but in many settings only domestic cloth made masks are available to the majority of the people. However, masks can be of different quality and very little is known about the utility of cloth face masks at the community level.\n\nIn Bandim Health Project's Health and Demographic Surveillance System we will evaluate the effect of providing locally produced cloth face masks on severity of COVID-19 like illness and mortality in an urban population. The locally produced cloth mask is made according to a laboratory certified model and will be provided to the intervention group alongside information of how the risk of transmission can be reduced. The control group will receive information alone.\n\nFollow-up will be implemented through telephone calls and post-epidemic home visits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Household resident\n* Age: 10 years and older\n\nExclusion Criteria:\n\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT04471766', 'briefTitle': 'Locally Produced Cloth Face Mask and COVID-19 Like Illness Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Bandim Health Project'}, 'officialTitle': 'Evaluation of Locally Produced Cloth Face Mask on COVID-19 and Respiratory Illnesses Prevention at the Community Level - a Cluster-randomized Trial', 'orgStudyIdInfo': {'id': 'BHP MASK01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Certified cloth face mask plus preventive information', 'description': 'Certified cloth face mask', 'interventionNames': ['Other: Certified cloth face mask plus preventive information', 'Behavioral: Preventive information']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Information on COVID-19 prevention', 'description': 'Advice on how to prevent COVID-19 according to the government´ policy.', 'interventionNames': ['Behavioral: Preventive information']}], 'interventions': [{'name': 'Certified cloth face mask plus preventive information', 'type': 'OTHER', 'description': 'Provision of two face masks sewed locally following a certified model tested for FORCE in the laboratory per residents \\> 10 years old', 'armGroupLabels': ['Certified cloth face mask plus preventive information']}, {'name': 'Preventive information', 'type': 'BEHAVIORAL', 'description': 'Advice on how to prevent COVID-19 according to the government´ policy', 'armGroupLabels': ['Certified cloth face mask plus preventive information', 'Information on COVID-19 prevention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bissau', 'state': 'Bissau Codex', 'country': 'Guinea-Bissau', 'facility': 'Bandim Health Project', 'geoPoint': {'lat': 11.86357, 'lon': -15.59767}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bandim Health Project', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern Denmark', 'class': 'OTHER'}, {'name': 'Engineers without Borders, Denmark (https://iug.dk/en)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}