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NCT Number: NCT04455308

COVID-19 and Chilblains

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.

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Key information

Conditions

Chilblains COVID-19 Cold Injury Coronaviridae Infections Coronavirus Infections Frostbite Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological sample collection

Other

10mL blood sample

Primary outcomes

  1. Level of viral exposure in "case family" compared to "comparator family"

    Time frame: Through study completion, an average of 3 months

Secondary outcomes

  1. Comparison of seropositivity rates in subjects with chilblains and their age-matched controls

    Time frame: 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

    Time frame: Through study completion, an average of 3 months

  3. Antibody avidity and differentiated IgG and IgM assay by subject in the homes

    Time frame: Through study completion, an average of 3 months

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Chilblains, COVID-19 and Lockdown: Epidemiologic Study

Acronym: ECCES

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2020
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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