ECCES: COVID-19 and Chilblains

• Sponsor: Rennes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04455308
• Collaborator: (none)
• Enrollment: 269
• Locations: 5
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site: 53.8
• Patients Per Site Per Month: 18.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chilblains; COVID-19	Diagnostic Test: Biological sample collection	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 269 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Chilblains, COVID-19 and Lockdown: Epidemiologic Study
• Actual Study Start Date: Jul 21, 2020
• Actual Primary Completion Date: Oct 19, 2020
• Actual Study Completion Date: Oct 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subjects with chilblains	Diagnostic Test: Biological sample collection; 10mL blood sample
Active Comparator: Subjects without chilblains	Diagnostic Test: Biological sample collection; 10mL blood sample

Outcome Measures

Primary Outcome Measures

1. Level of viral exposure in "case family" compared to "comparator family" [Through study completion, an average of 3 months]

Secondary Outcome Measures

1. Comparison of seropositivity rates in subjects with chilblains and their age-matched controls [Through study completion, an average of 3 months]

2. 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]

3. Antibody avidity and differentiated IgG and IgM assay by subject in the homes [Through study completion, an average of 3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Angers	Angers		France	49933
2	CHRU Brest	Brest		France	29609
3	CHU Nantes	Nantes		France	44093
4	CHU Rennes	Rennes		France	35033
5	CHRU Tours	Tours		France	37170

Sponsors and Collaborators

• Rennes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rennes University Hospital
• ClinicalTrials.gov Identifier: NCT04455308
• Other Study ID Numbers: 35RC20_8888_ECCES
• First Posted: Jul 2, 2020
• Last Update Posted: Nov 4, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Chilblains

Study Results

No Results Posted as of Nov 4, 2020