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ChilblainCOVID: Assessment of Chilbains Occuring During Covid-19 Infection

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Unknown status
CT.gov ID
NCT04344119
Collaborator
(none)
30
Enrollment
1
Location
12.7
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Some patients infected by covid-19 develop skin manifestations. These manifestations are still not well known and there pathophysiology remain unclear. Among them, acral manifestation resembling to chilblains appears frequent and quite specific. The aim of this project is to better characterize the cutaneous manifestations occurring during Covid-19 infection with a special focus on chilblains. These acral manifestation could be due to a direct viral effect, but also to microthrombosis or vascularitis. Understanding the pathomechanisms involved could provide interesting clue for understanding not only the skin manifestations but also some of the other systemic symptoms associated to covid-19 infection. This study plan to characterize these acral manifestations by analyzing the clinical and dermoscopic patterns and to correlate them with the non-invasive vascular explorations but also immune and coagulopathy explorations that are done in the CHU of Nice in covid-19 patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Skin Manifestations Occuring During Covid-19 Infection With a Special Focus on Chilbains
    Actual Study Start Date :
    Apr 9, 2020
    Anticipated Primary Completion Date :
    Apr 30, 2021
    Anticipated Study Completion Date :
    Apr 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Clinical skin manifestations [3 months]

      Type and description of the skin manifestations with a special focus on patients with chilblains

    Secondary Outcome Measures

    1. Histology and biological data [3 months]

      Data on Histology (HE staining and immunofluorescence) and on biology (blood cells counts, CRP and immune profile) will be collected in covid patient with skin manifestation

    2. Non invasive vascular examination [3 months]

      Vascular examination will be performed by Capillaroscopy, laser-doppler or lung TDM if clinically required

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 90 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • All patients with proven covid infection (using PCR, serum antibody or lung TDM) and presenting at least one cutaneous lesions that occurred during the infection.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Nice Nice France 06200

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Nice

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Nice
    ClinicalTrials.gov Identifier:
    NCT04344119
    Other Study ID Numbers:
    • 20dermatocovid01
    First Posted:
    Apr 14, 2020
    Last Update Posted:
    Jan 20, 2021
    Last Verified:
    Apr 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Skin Manifestations
    Chilblains

    Study Results

    No Results Posted as of Jan 20, 2021