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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

Tracking Information
First Submitted Date  ICMJE June 30, 2020
First Posted Date  ICMJE July 2, 2020
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE July 21, 2020
Actual Primary Completion Date October 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2020)
Level of viral exposure in "case family" compared to "comparator family" [ Time Frame: Through study completion, an average of 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2020)
  • Comparison of seropositivity rates in subjects with chilblains and their age-matched controls [ Time Frame: 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 ]
  • Antibody avidity and differentiated IgG and IgM assay by subject in the homes [ Time Frame: Through study completion, an average of 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COVID-19 and Chilblains
Official Title  ICMJE Chilblains, COVID-19 and Lockdown: Epidemiologic Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Chilblains
  • COVID-19
Intervention  ICMJE Diagnostic Test: Biological sample collection
10mL blood sample
Study Arms  ICMJE
  • Experimental: Subjects with chilblains
    Intervention: Diagnostic Test: Biological sample collection
  • Active Comparator: Subjects without chilblains
    Intervention: Diagnostic Test: Biological sample collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2020)
269
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2020)
300
Actual Study Completion Date  ICMJE October 19, 2020
Actual Primary Completion Date October 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04455308
Other Study ID Numbers  ICMJE 35RC20_8888_ECCES
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rennes University Hospital
Study Sponsor  ICMJE Rennes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rennes University Hospital
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP