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Assessment of Chilbains Occuring During Covid-19 Infection (ChilblainCOVID)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04344119
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : May 13, 2020
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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
Skin Manifestations COVID Chilblains

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Study Type : Observational
Estimated 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 : April 9, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Clinical skin manifestations [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months ]
    Vascular examination will be performed by Capillaroscopy, laser-doppler or lung TDM if clinically required

Biospecimen Retention:   Samples Without DNA
Serum, skin biopsy, urine

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients with covid infection presenting with skin manifestations

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04344119

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Contact: Cynthia CAILLON +33492034011
Contact: Sylvie MALERBA +33492034011

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CHU de Nice Recruiting
Nice, France, 06200
Contact: Thierry PASSERON         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Nice Identifier: NCT04344119    
Other Study ID Numbers: 20dermatocovid01
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Manifestations
Cold Injury
Wounds and Injuries