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

NCT04387955 | Completed

• 1 other identifier: ACROVID
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Chilblains

Outcome Measures

Primary Outcomes (1)

• Study of the link between SARS-CoV-2 infection and chilblains observed during COVID-19 epidemics.

  Main Judgement Criterion Comparison between the proportion of patients with chilblains presenting a SARS-CoV-2 positive virological status and the estimated proportion of SARS-CoV-2 positive virological status in the general population. The SARS-CoV-2 positive virological status of patients with chilblains will be defined by : * SARS-CoV-2 Reverse Transcription-Polymerase Chain Reaction (RT-PCR) on a positive nasopharyngeal swab pre-inclusion. * And/or RT-PCR SARS-CoV-2 on positive anal swab at D0 * And/or RT-PCR SARS-CoV-2 on skin bubble fluid positive at D0. * And/or RT-PCR SARS-CoV-2 on skin biopsy positive at D0. * And/or SARS-CoV-2 serology positive at D0 and/or M1 and/or M2.

  2 months

Secondary Outcomes (9)

• Study of the SARS-CoV-2 virological profile of patients presenting chilblains during a COVID-19 epidemic.

  2 months

• Comparison of the clinical and biological profiles of patients presenting chilblains according to their SARS-CoV-2 virological status (in case of over-representation of SARS-CoV-2 positive patients, the results will be given without comparison).

  2 months

• Comparison of the capillaroscopic profiles of patients with chilblains according to their SARS-CoV-2 virological status (in case of overrepresentation of SARS-CoV-2 positive patients, the results will be given without comparison).

  2 months

• Comparison of the TCPO2 profiles of patients with chilblains according to their SARS-CoV-2 virological status (in case of overrepresentation of SARS-CoV-2 positive patients, the results will be given without comparison).

  2 months

• Comparison of the toe or Finger Pressure Index profiles of patients with chilblains according to their SARS-CoV-2 virological status (in case of overrepresentation of SARS-CoV-2 positive patients, the results will be given without comparison).

  2 months

Study Arms (1)

Acrovid

OTHER

Cohort

Diagnostic Test: Biological Sample Collection

Interventions

Biological Sample Collection 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

Acrovid

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Absence of fever or respiratory signs suggestive of COVID-19 for at least 14 days

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU de Poitiers

Poitiers, 86000, France

Location

MeSH Terms

Conditions

COVID-19; Chilblains

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Frostbite; Cold Injury; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Cohort

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 14, 2020
• Study Start: April 30, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: November 29, 2021

Record last verified: 2021-11

Locations

FR (1)