Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-02-20 @ 6:49 PM
Study NCT ID:
NCT04462627
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2020-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of COVID 19 Transmission to Health Care Professionals
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 566}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2020-07-07', 'studyFirstSubmitQcDate': '2020-07-07', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-A antibody concentration', 'timeFrame': 'baseline', 'description': 'Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.'}, {'measure': 'Anti-A antibody concentration', 'timeFrame': 'Day 4', 'description': 'Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.'}, {'measure': 'Anti-A antibody concentration', 'timeFrame': 'Week 1', 'description': 'Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.'}, {'measure': 'Anti-A antibody concentration', 'timeFrame': 'Week 2', 'description': 'Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.'}, {'measure': 'Anti-A antibody concentration', 'timeFrame': 'Week 3', 'description': 'Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.'}, {'measure': 'Anti-B antibody concentration', 'timeFrame': 'baseline', 'description': 'Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.'}, {'measure': 'Anti-B antibody concentration', 'timeFrame': 'Day 4', 'description': 'Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.'}, {'measure': 'Anti-B antibody concentration', 'timeFrame': 'Week 1', 'description': 'Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.'}, {'measure': 'Anti-B antibody concentration', 'timeFrame': 'Week 2', 'description': 'Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.'}, {'measure': 'Anti-B antibody concentration', 'timeFrame': 'Week 3', 'description': 'Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.'}, {'measure': 'Blood group', 'timeFrame': 'baseline', 'description': 'Blood group (ABO/LE)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID 19']}, 'descriptionModule': {'briefSummary': 'When the COVID-19 virus infects a person, it enters the lung epithelial cells of its host and uses its genetic material to replicate.\n\nThe pulmonary epithelial cells of a part of the population, known as "secretors", are capable of expressing the antigens of the "ABO" system on their surface. This secretory status can be established by determining the antigens of the Lewis blood group system. When the virus replicates in an "secreting" individual, the antigens of the "ABO" system of the infected individual will be present on the surface of the viruses formed in his/her lungs.\n\nIt was shown in 2003 that the response of a given individual to the transmission of a virus depends on his/her blood group and on the antigens of the "ABO" system carried by the virus. A patient of group "O" would thus defend himself much better against a virus carrying antigens of blood group "A", the natural antibodies "anti-A" of the patient reducing the ability of the virus to bind to its specific receptor on pulmonary epithelial cells, to penetrate them to replicate itself. The first data collected in Wuhan (China) seems to confirm this hypothesis. A COVID-19 virus transmission model can therefore be established on the basis of blood groups.\n\nIn order to reduce the spread of the virus among nursing staff, it is possible to establish a preferential algorithm for patient management based on the "ABO" and "Lewis" blood groups of patients and "ABO" of nursing staff in health care units, if operational and human conditions allow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COVID19 positive patients admitted within the CHU Brugmann Hospital\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04462627', 'briefTitle': 'Reduction of COVID 19 Transmission to Health Care Professionals', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Reduction of COVID 19 Transmission to Health Care Professionals', 'orgStudyIdInfo': {'id': 'CHUB-BDS-COVID19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Covid 19 positive patients', 'interventionNames': ['Diagnostic Test: Blood group determination', 'Diagnostic Test: Antibody titration']}, {'type': 'EXPERIMENTAL', 'label': 'Covid 19 negative patients', 'interventionNames': ['Diagnostic Test: Blood group determination', 'Diagnostic Test: Antibody titration']}, {'type': 'EXPERIMENTAL', 'label': 'Untested healthy volunteers', 'interventionNames': ['Diagnostic Test: Blood group determination', 'Diagnostic Test: Antibody titration', 'Dietary Supplement: Probiotic']}], 'interventions': [{'name': 'Blood group determination', 'type': 'DIAGNOSTIC_TEST', 'description': 'Determination of the blood group (ABO/LE)', 'armGroupLabels': ['Covid 19 negative patients', 'Covid 19 positive patients', 'Untested healthy volunteers']}, {'name': 'Antibody titration', 'type': 'DIAGNOSTIC_TEST', 'description': 'Natural anti-A and anti-B antibody levels will be determined by a gel agglutination technique on the Biorad IH-500 automaton.', 'armGroupLabels': ['Covid 19 negative patients', 'Covid 19 positive patients', 'Untested healthy volunteers']}, {'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Administration of a probiotic to healthy volunteers to determine if it increases the level of circulating natural anti-A and anti-B antibodies (Probactiol Plus (Metagenics)).', 'armGroupLabels': ['Untested healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Hanane El Kenz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Brugmann'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanane EL KENZ', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head Physician of the Blood Bank', 'investigatorFullName': 'Hanane EL KENZ', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}