Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
Study NCT ID:
NCT04416893
Status:
WITHDRAWN
Last Update Posted:
2021-05-27
First Post:
2020-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Part 2 on the Study Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children (COVILLE2) (WHO)
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': 'D000087123', 'term': 'COVID-19 Nucleic Acid Testing'}], 'ancestors': [{'id': 'D000086742', 'term': 'COVID-19 Testing'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'With the rapid evolution of COVID-19, the objective was no longer relevant', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-25', 'studyFirstSubmitDate': '2020-06-02', 'studyFirstSubmitQcDate': '2020-06-02', 'lastUpdatePostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of asymptomatic children or children with mild respiratory symptoms', 'timeFrame': 'At inclusion', 'description': 'Proportion of asymptomatic children or children with mild respiratory symptoms (mildly-symptomatic children) with a positive SARS-Cov2 Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) on rhino pharyngeal swab or/and IgM/IgG positive serology in Paris area'}], 'secondaryOutcomes': [{'measure': 'Cov2-SARS cases by age', 'timeFrame': 'At inclusion'}, {'measure': 'Cov2-SARS cases by symptoms', 'timeFrame': 'At inclusion'}, {'measure': 'Viral load', 'timeFrame': 'At inclusion', 'description': 'The viral load of children with SARS-Cov2 positive Reverse Transcriptase Polymerase Chain Reaction depending on the symptoms and the age of the patients'}, {'measure': 'Presence of anti-SARS-CoV-2 antibodies (IgM and IgG) by the rapid serological test', 'timeFrame': 'At inclusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RT-PCR SARS-CoV-2', 'Serology SARS-CoV-2', 'Children'], 'conditions': ['COVID19']}, 'descriptionModule': {'briefSummary': 'France and in particular the paris area was one of the countries most affected by the pandemic Covid19.\n\nSchool closures and a generalized lockdown of the population were instituted in France from 17 March 2020 to 10 May 2020. Schools and nurseries have reopened partially since 11 May 2020. From 2 June, this reopening is more widespread. By combining the search for SARS-Cov2 viruses by PCR and micro-method serology we will be able to evaluate both the infection at a given time and also older contact with SARS-CoV2.\n\nThe temporal knowledge of the prevalence of SARS-Cov2 carriage and the serological status (IgM and IgG) after return to the community are crucial information to evaluate the speed of spread of the virus in children. This is the objective of COVILLE2, phase 2 of the COVILLE study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children under 15 years of age in a community (kindergarten, school, college, holiday centre, etc.).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Birth to 15 years old\n* taking over the community (kindergarten, school, college, holiday centre, etc.) for at least 1 week\n\nExclusion Criteria:\n\n* refusal to participate'}, 'identificationModule': {'nctId': 'NCT04416893', 'acronym': 'COVILLE2', 'briefTitle': 'Part 2 on the Study Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children (COVILLE2) (WHO)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children, a Cross-sectional, Prospective, Multicentre, Observational Study in Primary Care-Part 2 After the Lifting of the Lockdown', 'orgStudyIdInfo': {'id': 'COVILLE2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children under 15 years of age in a community', 'description': 'Children under 15 years of age in a community : kindergarten, school, college, holiday center, etc.', 'interventionNames': ['Diagnostic Test: RT-PCR SARS-Cov2', 'Diagnostic Test: Sars-Cov2 serology']}], 'interventions': [{'name': 'RT-PCR SARS-Cov2', 'type': 'DIAGNOSTIC_TEST', 'description': 'nasopharyngeal swab will be taken for detection of SARS-CoV-2 by RT-PCR', 'armGroupLabels': ['Children under 15 years of age in a community']}, {'name': 'Sars-Cov2 serology', 'type': 'DIAGNOSTIC_TEST', 'description': 'A microsample of blood will be taken for serology', 'armGroupLabels': ['Children under 15 years of age in a community']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'collaborators': [{'name': 'Association Clinique Thérapeutique Infantile du val de Marne', 'class': 'OTHER'}, {'name': 'Groupe de Pathologies Infectieuses Pédiatriques (GPIP)', 'class': 'OTHER'}, {'name': 'Francophone Pediatric Resuscitation and Emergency Group (GFRUP)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}