ChilblainsECCESNCT04455308
COVID-19 and Chilblains
A study testing Biological sample collection in people with Chilblains and COVID-19, run by Rennes University Hospital at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chilblains, COVID-19
- What is being tested?
- Biological sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 5 sitesFrance
- Study dates
- 21 Jul 2020to 19 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- "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
Who cannot join
- Subject legally protected (under judicial protection, guardianship), persons deprived of liberty
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Angers
Angers, 49933
CHRU Brest
Brest, 29609
CHU Nantes
Nantes, 44093
CHU Rennes
Rennes, 35033
CHRU Tours
Tours, 37170
About this study
Official title: 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.
- Conditions
- Chilblains, COVID-19
- Being tested
- Biological sample collection
- Medical subject headings
- Chilblains, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sample collectionOther
10mL blood sample
| Study group | Role | What they receive |
|---|---|---|
| Subjects with chilblains | Experimental | Not described Receives: Other: Biological sample collection |
| Subjects without chilblains | Active comparator | Not described Receives: Other: Biological sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of viral exposure in "case family" compared to "comparator family"
Measured: Through study completion, an average of 3 months
Secondary outcomes (3)
Comparison of seropositivity rates in subjects with chilblains and their age-matched controls
Measured: 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
Measured: Through study completion, an average of 3 months
Antibody avidity and differentiated IgG and IgM assay by subject in the homes
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start21 Jul 2020
- Primary completion19 Oct 2020
- Study completion19 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ChilblainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455308
- Sponsor's protocol ID
- 35RC20_8888_ECCES
- Acronym
- ECCES
- Status last verified
- May 2023
- First submitted
- 30 Jun 2020
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34515805Poizeau 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.
PubMed 34619397
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chilblains, COVID-19 and Lockdown: Epidemiologic Study
- ClinicalTrials.gov ID
- NCT04455308
- Acronym / sponsor ID
- ECCES / 35RC20_8888_ECCES
- Conditions
- Chilblains, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 19 Oct 2020 (actual)
- Study completion
- 19 Oct 2020 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with chilblains | Experimental | Other: Biological sample collection |
| Subjects without chilblains | Active comparator | Other: Biological sample collection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- "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
Key exclusion criteria (1 listed)
- Subject legally protected (under judicial protection, guardianship), persons deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological sample collection10mL blood sample | Other | Subjects with chilblains, Subjects without chilblains |
Primary outcome
Level of viral exposure in "case family" compared to "comparator family"
Time frame: Through study completion, an average of 3 months
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Results publication: PubMed 34515805Poizeau 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.
- Results publication: PubMed 34619397Poizeau 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.
Related trials for Chilblains
RecruitingObservational study
Assessment of Chilbains Occuring During Covid-19 Infection
Skin Manifestations, COVID
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological sample collection in people with Chilblains and COVID-19, run by Rennes University Hospital at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of viral exposure in "case family" compared to "comparator family" (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04455308, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.