Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-29 @ 7:10 AM
Study NCT ID:
NCT04355533
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2020-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunity Against SARS-CoV2 in Children and Their Parents / COVID-19
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': 'D012698', 'term': 'Serologic Tests'}], 'ancestors': [{'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1056}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2020-04-17', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroconversion against SARS-CoV2 in children', 'timeFrame': 'at inclusion', 'description': 'serology'}], 'secondaryOutcomes': [{'measure': 'Measure of Ab antiN and Ab anti-S1/2', 'timeFrame': 'at inclusion', 'description': 'Serology in children'}, {'measure': 'Neutralization activity', 'timeFrame': 'at inclusion', 'description': 'Serology in children'}, {'measure': 'Positive qPCR in children', 'timeFrame': 'at inclusion', 'description': 'in children, qualitative and quantitative measure , in nasopharynx, saliva and stool'}, {'measure': 'correlation between different Ab and qPCR and neutralization activity', 'timeFrame': 'at inclusion', 'description': 'in children, qualitative and quantitative measure , in nasopharynx, saliva and stool, Ab anti-N, Ab anti-S1/2, neutralization serum'}, {'measure': 'Protective immunity', 'timeFrame': 'Day 3', 'description': 'Serology, measure of Ab in PCR positive children'}, {'measure': 'Protective immunity', 'timeFrame': 'Day 7', 'description': 'Serology, measure of Ab in PCR positive children'}, {'measure': 'Protective immunity', 'timeFrame': 'Day 15', 'description': 'Serology, measure of Ab in PCR positive children'}, {'measure': 'Protective immunity', 'timeFrame': 'Day 45', 'description': 'Serology, measure of Ab in PCR positive children'}, {'measure': 'Protective immunity', 'timeFrame': 'At 6 months', 'description': 'Serology, measure of Ab in PCR positive children'}, {'measure': 'Protective immunity', 'timeFrame': 'At 12 months', 'description': 'Serology, measure of Ab in PCR positive children'}, {'measure': 'Duration of viral carriage in stool, saliva and or nasopharynx', 'timeFrame': 'until 45 days if persistence of positive qPCR', 'description': 'Sars-Cov2 PCR in PCR positive children'}, {'measure': 'Correlation between antibody profile and viral clearance', 'timeFrame': 'until 45 days post onset', 'description': 'Serology in PCR positive children'}, {'measure': 'Ab profile and memory of immunity', 'timeFrame': 'At Day 3', 'description': 'Immune cells in positive PCR children'}, {'measure': 'Ab profile and memory of immunity', 'timeFrame': 'At Day 7', 'description': 'Immune cells in positive PCR children'}, {'measure': 'Ab profile and memory of immunity', 'timeFrame': 'At Day 15', 'description': 'Immune cells in positive PCR children'}, {'measure': 'Ab profile and memory of immunity', 'timeFrame': 'At Day 45', 'description': 'Immune cells in positive PCR children'}, {'measure': 'Ab profile and memory of immunity', 'timeFrame': 'At 6 months', 'description': 'Immune cells in positive PCR children'}, {'measure': 'Ab profile and memory of immunity', 'timeFrame': 'At 12 months', 'description': 'Immune cells in positive PCR children'}, {'measure': 'saliva biofluid characteristics of COVID-19 infected', 'timeFrame': 'Until 1 year follow-up', 'description': 'viral content (qPCR and immunodetection); presence of IgG, M, and A'}, {'measure': 'Presence of the virus', 'timeFrame': 'Until 1 year follow-up', 'description': 'In PCR positive children: nasopharynx, saliva, stool'}, {'measure': 'Reinfection', 'timeFrame': 'Until 1 year follow-up', 'description': 'In PCR positive children: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus'}, {'measure': 'Transmission of the virus to the family', 'timeFrame': 'until 45 days follow-up', 'description': 'symptomatic, virological and serological follow-up'}, {'measure': 'Immune response', 'timeFrame': 'At inclusion', 'description': 'In children COVID+ during the first wave :immune response few months after the infection'}, {'measure': 'Mucosal immunity', 'timeFrame': 'Until 1 year follow-up', 'description': 'In PCR positive children: Ab anti-SARS-cov2 in nasopharynx samples'}, {'measure': 'seroconversion against SARS-CoV2 in parents', 'timeFrame': 'at inclusion', 'description': 'Ancillary study: Serology in parents'}, {'measure': 'Measure of Ab antiN and Ab anti-S1 and neutralization activity', 'timeFrame': 'at inclusion', 'description': 'Ancillary study: Serology in parents'}, {'measure': 'Positive qPCR in parents', 'timeFrame': 'at inclusion', 'description': 'Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva'}, {'measure': 'Correlation between different Ab and qPCR', 'timeFrame': 'at inclusion', 'description': 'Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva, Ab anti-N, Ab anti-S1, neutralization serum'}, {'measure': 'Correlation between antibody profile and viral clearance', 'timeFrame': 'until 45 days post onset', 'description': 'Ancillary study: Serology in PCR positive parents'}, {'measure': 'Ab profile and memory of immunity', 'timeFrame': 'at Day 3', 'description': 'Ancillary study: Immune cells in positive PCR parents'}, {'measure': 'Ab profile and memory of immunity', 'timeFrame': 'at Day 7', 'description': 'Ancillary study: Immune cells in positive PCR parents'}, {'measure': 'Ab profile and memory of immunity', 'timeFrame': 'at Day 15', 'description': 'Ancillary study: Immune cells in positive PCR parents'}, {'measure': 'Ab profile and memory of immunity', 'timeFrame': 'at Day 45', 'description': 'Ancillary study: Immune cells in positive PCR parents'}, {'measure': 'Ab profile and memory of immunity', 'timeFrame': 'at 6 months', 'description': 'Ancillary study: Immune cells in positive PCR parents'}, {'measure': 'Ab profile and memory of immunity', 'timeFrame': 'at 12 months', 'description': 'Ancillary study: Immune cells in positive PCR parents'}, {'measure': 'Saliva biofluid characteristics of COVID-19 infected', 'timeFrame': 'Until 1 year follow-up', 'description': 'in positive PCR parents: viral content (qPCR and immunodetection); presence of IgG, M, and A'}, {'measure': 'Presence of the virus', 'timeFrame': 'Until 45 days follow-up', 'description': 'in positive PCR parents: nasopharynx, saliva'}, {'measure': 'Mucosal immunity', 'timeFrame': 'Until 1 year follow-up', 'description': 'in positive PCR parents: Ab anti-SARS-cov2 in nasopharynx samples'}, {'measure': 'Reinfection', 'timeFrame': 'Until 1 year follow-up', 'description': 'in positive PCR parents: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Child', 'COVID-19 infection', 'immune response', 'healthy carrier'], 'conditions': ['COVID-19 Infection']}, 'referencesModule': {'references': [{'pmid': '36065993', 'type': 'RESULT', 'citation': "Delaunay-Moisan A, Guilleminot T, Semeraro M, Briand N, Bader-Meunier B, Berthaud R, Morelle G, Quartier P, Galeotti C, Basmaci R, Benoist G, Gajdos V, Lorrot M, Rifai M, Crespin M, M'Sakni Z, Padavia F, Savetier-Leroy C, Lorenzi M, Maurin C, Behillil S, de Pontual L, Elenga N, Bouazza N, Moltrecht B, van der Werf S, Leruez-Ville M, Sermet-Gaudelus I. Saliva for molecular detection of SARS-CoV-2 in pre-school and school-age children. Environ Microbiol. 2022 Oct;24(10):4725-4737. doi: 10.1111/1462-2920.16151. Epub 2022 Aug 12."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide data on the proportion of seroconverted children and their immune status. It will also provide insight into the number of children currently infected at each time point including healthy carriers. Investigators will provide similar data on their parents in an ancillary study.', 'detailedDescription': 'The fraction of undiagnosed but likely to transmit the virus is a critical epidemiological characteristic that modulates the epidemic potential of SARS-CoV2. To adapt the epidemy control, it is essential to study the immunoprotection of the general population. A crucial question is the study of pauci or asymptomatic subjects, and in particular children who make mild forms, because they could act as a real reservoir for the spread of the virus. The serological study is essential in this context.\n\nThe serologic test Abbott will be used to study immunoprevalence. Institut Pasteur has validated test using neutralizing Ab. CEA will used a antibodies and antigen test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor hospitalized children or consulting at hospital\n\n* any child over 7 days old and under 17 years old in consultation or hospitalized for at most 4 days at AP-HP or CH Cayenne; Or any child over 7 days old and under 17 years old with a positive PCR at home, with an attending physician in a participating centre\n* Parent's agreement for blood, saliva and stool samples\n* Optional parent's agreement for nasopharynx swab\n* Optional parent's agreement for follow-up if PCR+\n* With an Health insurance\n\nFor children with potential COVID disease during the first wave\n\n* Any child over 7 days old and under 17 years, seropositive during the first wave\n* Or any child over 7 days old and under 17 years, with a previous inflammatory clinical disease potentially linked to SARS-cov2\n* With an Health insurance\n\nParent of the enrolled child\n\n* One parent of the enrolled child on ped-covid\n* Agreement for blood and saliva samples\n* Optional agreement for nasopharynx swab\n* Optional parent's agreement for follow-up if PCR+\n* With an Health insurance\n\nFor children SARS-coV2 positive\n\n* any child less then 18 years old\n* infected by SARS-coV2\n* Parent's agreement for blood, saliva samples\n* Optional parent's agreement for nasopharynx swab\n* With health insurance\n\nFor people living under the same roof of a child included in the study\n\n* any child or adult living under the same roof of a child SARS-coV2 positive and included in the study\n* With health insurance\n\nExclusion Criteria:\n\nFor hospitalized children or consulting at hospital\n\n* child younger than 7 days\n* Refusal of parent\n* Refusal of child\n* No health insurance"}, 'identificationModule': {'nctId': 'NCT04355533', 'acronym': 'PED-COVID', 'briefTitle': 'Immunity Against SARS-CoV2 in Children and Their Parents / COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Seroprevalence and Antibody Profiling Against SARS-CoV2 in Children and Their Parents', 'orgStudyIdInfo': {'id': 'APHP200467'}, 'secondaryIdInfos': [{'id': '2020-A00999-30', 'type': 'REGISTRY', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hospitalized children or consulting at hospital', 'interventionNames': ['Biological: serology test', 'Biological: nasopharyngeal swab', 'Biological: rectal swab', 'Biological: saliva sample']}, {'type': 'EXPERIMENTAL', 'label': 'Parents of one included child', 'interventionNames': ['Biological: serology test', 'Biological: nasopharyngeal swab', 'Biological: saliva sample']}, {'type': 'EXPERIMENTAL', 'label': 'Children with potential COVID disease during the first wave', 'interventionNames': ['Biological: serology test', 'Biological: nasopharyngeal swab', 'Biological: rectal swab', 'Biological: saliva sample']}, {'type': 'EXPERIMENTAL', 'label': 'Children SARS-coV2 positive', 'interventionNames': ['Biological: serology test', 'Biological: nasopharyngeal swab', 'Biological: rectal swab', 'Biological: saliva sample']}, {'type': 'EXPERIMENTAL', 'label': 'Person living under the same roof as children included in the study', 'interventionNames': ['Biological: serology test', 'Biological: nasopharyngeal swab', 'Biological: rectal swab', 'Biological: saliva sample']}], 'interventions': [{'name': 'serology test', 'type': 'BIOLOGICAL', 'description': 'volume according to child weight', 'armGroupLabels': ['Children SARS-coV2 positive', 'Children with potential COVID disease during the first wave', 'Hospitalized children or consulting at hospital', 'Parents of one included child', 'Person living under the same roof as children included in the study']}, {'name': 'nasopharyngeal swab', 'type': 'BIOLOGICAL', 'description': 'nasopharyngeal swab for PCR', 'armGroupLabels': ['Children SARS-coV2 positive', 'Children with potential COVID disease during the first wave', 'Hospitalized children or consulting at hospital', 'Parents of one included child', 'Person living under the same roof as children included in the study']}, {'name': 'rectal swab', 'type': 'BIOLOGICAL', 'description': 'rectal swab for PCR', 'armGroupLabels': ['Children SARS-coV2 positive', 'Children with potential COVID disease during the first wave', 'Hospitalized children or consulting at hospital', 'Person living under the same roof as children included in the study']}, {'name': 'saliva sample', 'type': 'BIOLOGICAL', 'description': 'for biocollection', 'armGroupLabels': ['Children SARS-coV2 positive', 'Children with potential COVID disease during the first wave', 'Hospitalized children or consulting at hospital', 'Parents of one included child', 'Person living under the same roof as children included in the study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital necker Enfants-Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Isabelle SERMET-GAUDELUS, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique-Hôpitaux de Pars'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': "Commissariat A L'energie Atomique", 'class': 'OTHER_GOV'}, {'name': 'Institut Pasteur', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}