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COVID-19 and Chilblains (ECCES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04455308
Recruitment Status : Completed
First Posted : July 2, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : July 21, 2020
Actual Primary Completion Date : October 19, 2020
Actual Study Completion Date : October 19, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Level of viral exposure in "case family" compared to "comparator family" [ Time Frame: 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 [ 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04455308


Locations
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France
CHU Angers
Angers, France, 49933
CHRU Brest
Brest, France, 29609
CHU Nantes
Nantes, France, 44093
CHU Rennes
Rennes, France, 35033
CHRU Tours
Tours, France, 37170
Sponsors and Collaborators
Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04455308    
Other Study ID Numbers: 35RC20_8888_ECCES
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chilblains
Frostbite
Cold Injury
Wounds and Injuries