Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
Study NCT ID:
NCT04455308
Status:
COMPLETED
Last Update Posted:
2025-01-08
First Post:
2020-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COVID-19 and Chilblains
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002647', 'term': 'Chilblains'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D005627', 'term': 'Frostbite'}, {'id': 'D000067390', 'term': 'Cold Injury'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 269}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2020-06-30', 'studyFirstSubmitQcDate': '2020-07-01', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of viral exposure in "case family" compared to "comparator family"', 'timeFrame': 'Through study completion, an average of 3 months'}], 'secondaryOutcomes': [{'measure': 'Comparison of seropositivity rates in subjects with chilblains and their age-matched controls', 'timeFrame': 'Through study completion, an average of 3 months'}, {'measure': 'Comparison of SARS-CoV-2 seropositivity rates among members of case (subject with chilblains) and control (subject without chilblains) outbreaks', 'timeFrame': 'Through study completion, an average of 3 months'}, {'measure': 'Antibody avidity and differentiated IgG and IgM assay by subject in the homes', 'timeFrame': 'Through study completion, an average of 3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chilblains', 'COVID-19']}, 'referencesModule': {'references': [{'pmid': '34515805', 'type': 'RESULT', 'citation': 'Poizeau F, Barbarot S, Le Corre Y, Brenaut E, Samimi M, Aubert H, Toubel A, Dupuy A. Long-term Outcome of Chilblains Associated with SARS-CoV-2. Acta Derm Venereol. 2021 Dec 13;101(12):adv00614. doi: 10.2340/00015555-3930.'}, {'pmid': '34619397', 'type': 'RESULT', 'citation': 'Poizeau F, Oger E, Barbarot S, Le Corre Y, Samimi M, Brenaut E, Aubert H, Chambrelan E, Droitcourt C, Gissot V, Heslan C, Laurent C, Martin L, Misery L, Tattevin P, Toubel A, Thibault V, Dupuy A. Chilblains during lockdown are associated with household exposure to SARS-CoV-2: a multicentre case-control study. Clin Microbiol Infect. 2022 Feb;28(2):285-291. doi: 10.1016/j.cmi.2021.09.032. Epub 2021 Oct 4.'}]}, 'descriptionModule': {'briefSummary': 'Chilblains (inflammatory lesion of the feet or hands) have been reported with an unusual frequency during the confinement period, most commonly in children, teenagers and young adults. The aim of the ECCES study is to find out whether these manifestations of chilblains can be linked to the SARS-CoV-2 coronavirus.\n\nFor this, an epidemiologic study will compare two types of family (or more precisely people who were confined together in March-April-May):\n\n* "case family" in which at least one of the members had chilblains\n* "comparator family" in which none of the members had chilblains Environment (home lockdown) of the two types of family will be analyzed. Each member of the "family" will be suggested doing a serological test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* "case family"\n* at least one of the members with chilblains\n* diagnosis of chilblains (anamnesis and pictures) written informed consent\n* "comparator family"\n* none of the members with chilblains\n* one member matched on age (+/- 1 year) to a patient with chilblains\n* written informed consent\n\nExclusion Criteria:\n\n\\- Subject legally protected (under judicial protection, guardianship), persons deprived of liberty'}, 'identificationModule': {'nctId': 'NCT04455308', 'acronym': 'ECCES', 'briefTitle': 'COVID-19 and Chilblains', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Chilblains, COVID-19 and Lockdown: Epidemiologic Study', 'orgStudyIdInfo': {'id': '35RC20_8888_ECCES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects with chilblains', 'interventionNames': ['Other: Biological sample collection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subjects without chilblains', 'interventionNames': ['Other: Biological sample collection']}], 'interventions': [{'name': 'Biological sample collection', 'type': 'OTHER', 'description': '10mL blood sample', 'armGroupLabels': ['Subjects with chilblains', 'Subjects without chilblains']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '37170', 'city': 'Tours', 'country': 'France', 'facility': 'CHRU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}