COVID-19 and Chilblains

COVID-19 Clinical Trial

— ECCES  

Official title:

Chilblains, COVID-19 and Lockdown: Epidemiologic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04455308
• Other study ID #: 35RC20_8888_ECCES
• Status: Completed
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: October 19, 2020

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chilblains
• COVID-19

Intervention

Diagnostic Test:
• Biological sample collection
10mL blood sample

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHRU Brest	Brest
France	CHU Nantes	Nantes
France	CHU Rennes	Rennes
France	CHRU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (2)

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

Outcome

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