Back to resultsCOVID-19 and Chilblains (ECCES)
Primary Purpose
Chilblains, COVID-19
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological sample collection
Sponsored by
About this trial
This is an interventional other trial for Chilblains
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
Sites / Locations
- CHU Angers
- CHRU Brest
- CHU Nantes
- CHU Rennes
- CHRU Tours
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Subjects with chilblains
Subjects without chilblains
Arm Description
Outcomes
Primary Outcome Measures
Level of viral exposure in "case family" compared to "comparator family"
Secondary Outcome Measures
Comparison of seropositivity rates in subjects with chilblains and their age-matched controls
Comparison of SARS-CoV-2 seropositivity rates among members of case (subject with chilblains) and control (subject without chilblains) outbreaks
Antibody avidity and differentiated IgG and IgM assay by subject in the homes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04455308
Brief Title
COVID-19 and Chilblains
Acronym
ECCES
Official Title
Chilblains, COVID-19 and Lockdown: Epidemiologic Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
October 19, 2020 (Actual)
Study Completion Date
October 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chilblains, COVID-19
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
269 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with chilblains
Arm Type
Experimental
Arm Title
Subjects without chilblains
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Biological sample collection
Intervention Description
10mL blood sample
Primary Outcome Measure Information:
Title
Level of viral exposure in "case family" compared to "comparator family"
Time Frame
Through study completion, an average of 3 months
Secondary Outcome Measure Information:
Title
Comparison of seropositivity rates in subjects with chilblains and their age-matched controls
Time Frame
Through study completion, an average of 3 months
Title
Comparison of SARS-CoV-2 seropositivity rates among members of case (subject with chilblains) and control (subject without chilblains) outbreaks
Time Frame
Through study completion, an average of 3 months
Title
Antibody avidity and differentiated IgG and IgM assay by subject in the homes
Time Frame
Through study completion, an average of 3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHRU Tours
City
Tours
ZIP/Postal Code
37170
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
34515805
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.
Results Reference
result
PubMed Identifier
34619397
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.
Results Reference
result
Learn more about this trial
COVID-19 and Chilblains
We'll reach out to this number within 24 hrs