COVID-19 Clinical Trial
— ECCESOfficial title:
Chilblains, COVID-19 and Lockdown: Epidemiologic Study
Verified date | May 2023 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. For this, an epidemiologic study will compare two types of family (or more precisely people who were confined together in March-April-May): - "case family" in which at least one of the members had chilblains - "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.
Status | Completed |
Enrollment | 269 |
Est. completion date | October 19, 2020 |
Est. primary completion date | October 19, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - "case family" - at least one of the members with chilblains - diagnosis of chilblains (anamnesis and pictures) written informed consent - "comparator family" - none of the members with chilblains - one member matched on age (+/- 1 year) to a patient with chilblains - written informed consent Exclusion Criteria: - Subject legally protected (under judicial protection, guardianship), persons deprived of liberty |
Country | Name | City | State |
---|---|---|---|
France | CHU Angers | Angers | |
France | CHRU Brest | Brest | |
France | CHU Nantes | Nantes | |
France | CHU Rennes | Rennes | |
France | CHRU Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
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. — View 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 ex — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of viral exposure in "case family" compared to "comparator family" | Through study completion, an average of 3 months | ||
Secondary | Comparison of seropositivity rates in subjects with chilblains and their age-matched controls | Through study completion, an average of 3 months | ||
Secondary | Comparison of SARS-CoV-2 seropositivity rates among members of case (subject with chilblains) and control (subject without chilblains) outbreaks | Through study completion, an average of 3 months | ||
Secondary | Antibody avidity and differentiated IgG and IgM assay by subject in the homes | Through study completion, an average of 3 months |
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