NCT04455308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
269

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

July 21, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2020

Completed
Last Updated

January 8, 2025

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

June 30, 2020

Last Update Submit

January 6, 2025

Conditions

ChilblainsCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Level of viral exposure in "case family" compared to "comparator family"

    Through study completion, an average of 3 months

Secondary Outcomes (3)

  • 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

Study Arms (2)

Subjects with chilblains

EXPERIMENTAL
Other: Biological sample collection

Subjects without chilblains

ACTIVE COMPARATOR
Other: Biological sample collection

Interventions

Biological sample collectionOTHER

10mL blood sample

Subjects with chilblainsSubjects without chilblains

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • "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

You may not qualify if:

  • \- Subject legally protected (under judicial protection, guardianship), persons deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Angers

Angers, 49933, France

Location

CHRU Brest

Brest, 29609, France

Location

CHU Nantes

Nantes, 44093, France

Location

CHU Rennes

Rennes, 35033, France

Location

CHRU Tours

Tours, 37170, France

Location

Related 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.

    PMID: 34515805RESULT

  • 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.

    PMID: 34619397RESULT

MeSH Terms

Conditions

ChilblainsCOVID-19

Condition Hierarchy (Ancestors)

FrostbiteCold InjuryWounds and InjuriesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 2, 2020

Study Start

July 21, 2020

Primary Completion

October 19, 2020

Study Completion

October 19, 2020

Last Updated

January 8, 2025

Record last verified: 2023-05

Locations

FR(5)