COVID-19 and Chilblains

Not Applicable

Completed

• Conditions: COVID-19; Chilblains
• Interventions: Diagnostic Test: Biological sample collection

• Registration Number: NCT04455308
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-02
• Study Start: 2020-07-21
• Primary Completion: 2020-10-19
• Study Completion: 2020-10-19
• Status Verified: 2023-05
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects with chilblains	Biological sample collection	-
Subjects without chilblains	Biological sample collection	-

Primary Outcome Measures

Name	Time	Method
Level of viral exposure in "case family" compared to "comparator family"	Through study completion, an average of 3 months

Secondary Outcome Measures

Name	Time	Method
Comparison of seropositivity rates in subjects with chilblains and their age-matched controls	Through study completion, an average of 3 months
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
Antibody avidity and differentiated IgG and IgM assay by subject in the homes	Through study completion, an average of 3 months

Trial Locations

Locations (5)

CHU Angers; 🇫🇷 Angers, France

CHRU Brest; 🇫🇷 Brest, France

CHU Nantes; 🇫🇷 Nantes, France

CHU Rennes; 🇫🇷 Rennes, France

CHRU Tours; 🇫🇷 Tours, France