NCT04344119

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

January 20, 2021

Status Verified

April 1, 2020

Enrollment Period

1.1 years

First QC Date

April 9, 2020

Last Update Submit

January 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical skin manifestations

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

    3 months

Secondary Outcomes (2)

  • Histology and biological data

    3 months

  • Non invasive vascular examination

    3 months

Eligibility Criteria

AgeUp to 90 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with covid infection presenting with skin manifestations

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, 06200, France

RECRUITING

Related Publications (1)

  • Hubiche T, Cardot-Leccia N, Le Duff F, Seitz-Polski B, Giordana P, Chiaverini C, Giordanengo V, Gonfrier G, Raimondi V, Bausset O, Adjtoutah Z, Garnier M, Burel-Vandenbos F, Dadone-Montaudie B, Fassbender V, Palladini A, Courjon J, Mondain V, Contenti J, Dellamonica J, Leftheriotis G, Passeron T. Clinical, Laboratory, and Interferon-Alpha Response Characteristics of Patients With Chilblain-like Lesions During the COVID-19 Pandemic. JAMA Dermatol. 2021 Feb 1;157(2):202-206. doi: 10.1001/jamadermatol.2020.4324.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, skin biopsy, urine

MeSH Terms

Conditions

Skin ManifestationsChilblains

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsFrostbiteCold InjuryWounds and Injuries

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 14, 2020

Study Start

April 9, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

January 20, 2021

Record last verified: 2020-04

Locations