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Analysis of Chilblains pROfile During coVID-19 Epidemic (ACROVID)

NCT ID: NCT04387955

Last Updated: 2021-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2021-07-30

Brief Summary

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Cases of chilblains have been reported with an unusual frequency in France in the context of the COronaVirus Infectious Disease 2019 (COVID-19) epidemic. Some of these cases have been linked to a virological status in favour of a recent Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) infection. Chilblains are acral inflammatory lesion typically reactive to cold (primary form). There are secondary forms acquired during autoimmune connectivitis such as lupus chilblain or hereditary forms related to type I Interferonopathy. An interferon type I signature has been described in these secondary forms of frostbite but also during the cytokine storm of severe forms of CoV-2 SARS infection. If cases of frostbite are indeed secondary to an SARS-CoV-2 infection, comparative analysis of their immunopathological profiles could provide a better understanding of the inflammatory mechanisms during COVID-19.

Detailed Description

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Conditions

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COVID-19 Chilblains

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective Cohort
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Acrovid

Cohort

Group Type OTHER

Biological Sample Collection

Intervention Type DIAGNOSTIC_TEST

* Diagnostic test : biological sample collection at Day 0
* Two skin biopsies on chilblain at Day 0 (one biopsy for histological analysis, one biopsy for basic research)
* Anal swabbing at Day 0
* Blood test at Day 0
* Blood test at Month 1
* Blood test at Month 2

Interventions

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Biological Sample Collection

* Diagnostic test : biological sample collection at Day 0
* Two skin biopsies on chilblain at Day 0 (one biopsy for histological analysis, one biopsy for basic research)
* Anal swabbing at Day 0
* Blood test at Day 0
* Blood test at Month 1
* Blood test at Month 2

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patient over the age of majority or a minor over 12 years of age accompanied by his/her legal representative
* Benefiting from a Social Security scheme
* Informed consent signed by the patient (if major) or by his legal representative (if minor) after clear, fair and appropriate information about the study.
* Red and swollen lesions of the hands and/or feet evolving for more than 24 hours in the context of a COVID-19 epidemic.
* PCR SARS-CoV-2 PCR on nasopharyngeal swab with results available, prior to the inclusion visit.
* Absence of fever or respiratory signs suggestive of COVID-19 for at least 14 days

Exclusion Criteria

* A person who does not benefit from a Social Security scheme or who does not benefit from it through a third party.
* Patient who is subject to a judicial safeguard measure
* Allergy to local anaesthetic products
* Fever or respiratory signs suggestive of COVID-19 within 14 days
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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ACROVID

Identifier Type: -

Identifier Source: org_study_id