Clinical trial NCT04455308: COVID-19 and Chilblains
Official title: Chilblains, COVID-19 and Lockdown: Epidemiologic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chilblains
COVID-19
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 269
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Level of viral exposure in "case family" compared to "comparator family"
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
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
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: CHRU Brest
city: Nantes
country: France
facility: CHU Nantes
city: Rennes
country: France
facility: CHU Rennes
city: Tours
country: France
facility: CHRU Tours
Study officials:
References:
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.
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.