Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-28 @ 7:49 AM
Study NCT ID:
NCT04417335
Status:
UNKNOWN
Last Update Posted:
2020-06-04
First Post:
2020-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing COVID-19 Related Hospital Admission in Elderly by BCG Vaccination
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': 'D001500', 'term': 'BCG Vaccine'}], 'ancestors': [{'id': 'D032581', 'term': 'Tuberculosis Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'placebo-controlled adaptive multi-centre randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2014}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-03', 'studyFirstSubmitDate': '2020-05-25', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SARS-CoV-2 related hospital admission', 'timeFrame': 'Maximum of 1 year'}], 'secondaryOutcomes': [{'measure': 'the duration of hospital admission due to documented COVID-19', 'timeFrame': 'Maximum of 1 year'}, {'measure': 'the cumulative incidence of documented SARS-CoV-2 infection', 'timeFrame': 'Maximum of 1 year'}, {'measure': 'the cumulative incidence of self-reported acute respiratory symptoms or fever', 'timeFrame': 'Maximum of 1 year'}, {'measure': 'the cumulative incidence of death due to documented SARS-CoV-2 infection', 'timeFrame': '1 year'}, {'measure': 'the cumulative incidence of hospital admission for any reason', 'timeFrame': 'Maximum of 1 year'}, {'measure': 'the cumulative incidence of Intensive Care Admission due to documented SARS-CoV-2 infection', 'timeFrame': 'Maximum of 1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BCG', 'Bacille Calmette-Guérin', 'COVID-19', 'SARS-CoV-2', 'trained immunity', 'off-target effects'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '36875134', 'type': 'DERIVED', 'citation': 'Fohse K, Taks EJM, Moorlag SJCFM, Bonten MJM, van Crevel R, Ten Oever J, van Werkhoven CH, Netea MG, van de Maat JS, Hoogerwerf JJ. The impact of circadian rhythm on Bacillus Calmette-Guerin vaccination effects on SARS-CoV-2 infections. Front Immunol. 2023 Feb 16;14:980711. doi: 10.3389/fimmu.2023.980711. eCollection 2023.'}, {'pmid': '35247264', 'type': 'DERIVED', 'citation': 'Moorlag SJCFM, Taks E, Ten Doesschate T, van der Vaart TW, Janssen AB, Muller L, Ostermann P, Dijkstra H, Lemmers H, Simonetti E, Mazur M, Schaal H, Ter Heine R, van de Veerdonk FL, Bleeker-Rovers CP, van Crevel R, Ten Oever J, de Jonge MI, Bonten MJ, van Werkhoven CH, Netea MG. Efficacy of BCG Vaccination Against Respiratory Tract Infections in Older Adults During the Coronavirus Disease 2019 Pandemic. Clin Infect Dis. 2022 Aug 24;75(1):e938-e946. doi: 10.1093/cid/ciac182.'}]}, 'descriptionModule': {'briefSummary': 'Bacillus Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but has also been shown to induce protection against various infections with a viral aetiology, leading to significant reductions in morbidity and mortality. We hypothesize that BCG vaccination might be a potent preventive measure against SARS-CoV-2 infection and/or may reduce disease severity in elderly people, who are known to be at increased risk of illness and death from SARS-CoV-2 infection.\n\nTherefore, we will in this placebo-controlled adaptive multi-centre randomized controlled trial evaluate the ability of BCG to reduce hospital admission and its efficacy to improve the clinical course of SARS-CoV-2 infection in elderly people((≥ 60 years of age).', 'detailedDescription': 'On March 11 2020 the World Health Organization (WHO) declared the coronavirus (SARS-CoV-2) outbreak a pandemic. The number of confirmed cases continues to rise, leading to significant morbidity and mortality worldwide. Although individuals of any age can acquire SARS-CoV-2, adults of middle age and older are most commonly affected. Moreover, recent reports demonstrate that mortality rates rise significantly among patients 60 years and older. Therefore, strategies to prevent SARS-CoV-2 infection or to reduce its clinical consequences in elderly are desperately needed. Bacillus Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but has also been shown to induce protection against various infections with a viral aetiology, leading to significant reductions in morbidity and mortality. We hypothesize that BCG vaccination may reduce hospital admission and improve the clinical course of symptoms of elderly people during the SARS-CoV-2 outbreak. Primary objective: To reduce hospital admission of community dwelling older persons during the pandemic of SARS-CoV-2. Secondary objective: To reduce disease severity, the duration of hospital admission, ICU admission, or death in elderly during the pandemic of SARS-CoV-2.\n\nStudy design: A placebo-controlled adaptive multi-centre randomized controlled trial.\n\nStudy population: Elderly people (≥ 60 years of age). Intervention: Participants will be randomized between intracutaneous administration of BCG vaccine or placebo in a 1:1 ratio.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥ 60 years)\n\nExclusion Criteria:\n\n* Fever (\\>38 ºC) within the past 24 hours\n* Suspicion of current active viral or bacterial infection\n* Expected vaccination during the first three months of the study period\n* Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) neutropenic subjects with less than 500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any immunosuppressant drugs such as anti-cytokine therapies, and treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months, or probable use of oral or intravenous steroids in the following four weeks.\n* Active solid or non-solid malignancy or lymphoma within the prior two years\n* Active participation in another research study that involves BCG administration'}, 'identificationModule': {'nctId': 'NCT04417335', 'briefTitle': 'Reducing COVID-19 Related Hospital Admission in Elderly by BCG Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Reducing Hospital Admission of Elderly in SARS-CoV-2 Pandemic Via the Induction of Trained Immunity by Bacillus Calmette-Guérin Vaccination, a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NL73430.091.20'}, 'secondaryIdInfos': [{'id': '2020-001591-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'BCG vaccine (Danish strain 1331, SSI, Denmark)', 'interventionNames': ['Biological: BCG vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0.9% NaCl', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'BCG vaccine', 'type': 'BIOLOGICAL', 'description': 'Bacille Calmette-Guérin is a live attenuated strain of Mycobacterium bovis developed in 1921 to prevent tuberculosis and other mycobacterial related infections.', 'armGroupLabels': ['Treatment']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': '0.9% NaCl', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525 GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboud University', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}