COVID-19 and Chilblains (ECCES)

May 22, 2023 updated by: Rennes University Hospital

Chilblains, COVID-19 and Lockdown: Epidemiologic Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

269

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • CHU Angers
      • Brest, France, 29609
        • CHRU Brest
      • Nantes, France, 44093
        • CHU Nantes
      • Rennes, France, 35033
        • CHU Rennes
      • Tours, France, 37170
        • CHRU Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of viral exposure in "case family" compared to "comparator family"
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2020

Primary Completion (Actual)

October 19, 2020

Study Completion (Actual)

October 19, 2020

Study Registration Dates

First Submitted

June 30, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC20_8888_ECCES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Biological sample collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe