Official Title
COVID-19 and Rare Skin Diseases. European Observational Study (Data Research) During an Epidemic
Brief Summary

This is a European observational cohort study (data research) involving multiple centresto look at the potential impact of COVID infection on patients with rare skin diseasesexamining factors such as comorbidity, protection factors, and clinical and/ortherapeutic factors. The data collected may provide additional information on thesituation of patients and, on a wider basis, provide useful data applicable to thegeneral population.

Detailed Description

Medical and demographic data will be collected from the medical records of patients. The
data required will be specified in Appendix 1 (collection form). Patients will be
identified by their initials (first letter of their surname and first name); The study
will last for one year to cover the COVID-19 epidemic in France (which includes the areas
of mainland France and its overseas departments and territories) and in Europe, via the
ERN-Skin European Network.

The frequency of severe forms of COVID-19 will be calculated with a bilateral 95%
confidence interval using, as a numerator, the number of patients with a severe form of
COVID-19 and, as a denominator, the number of patients with a COVID-19 diagnosis
confirmed by PCR, chest scan, serological assay or by suggestive clinical signs during
the medical consultation. A severe form of COVID is defined as a case requiring
hospitalisation in an intensive care unit, requiring resuscitation, or resulting in
death.

Analysis of the impact of COVID-19 infection on rare skin diseases: complications,
potential comorbidity factors, impact on the management of chronic conditions (change in
treatment) and the experience of patients.

The results of the analysis may be compared with those obtained for other groups of
diseases. Gaining a better understanding of high-risk situations, as well as any
aggravation or protective factors, should enable us to issue recommendations adapted to
this kind of disease but that may also be useful for the general population. This type of
study may also provide "reassurance" to patients with rare diseases who have many
questions during this period of epidemic and heightened concern.

Unknown status
Rare Diseases
Eligibility Criteria

Inclusion Criteria:

- Patient with a rare skin disease,

- Patient of any age (paediatric or adult),

- Patient with suspected COVID-19 infection (remote consultation, face-to-face
consultation, general practitioner, hospital physician),

- Patient in contact with a subject infected with the COVID-19 virus,

- Asymptomatic patient for COVID-19 viral infection but with a positive serology,

- Study information given to the patient and/or to their legal representative,

- Patient who has been informed and has agreed to this data collection process.

Exclusion Criteria:

- Patients not suffering from a rare skin disease,

- Patient and/or their legal representative who object to their participation in the
study at the presentation of the information leaflet,

- Adult patient unable to understand the implications and constraints of the study,

- Protected adult subject to guardianship or safeguarding measures.

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
Czechia
France
Germany
Italy
Lithuania
Locations

University Hospital Brno - EB Centrum CR Dermatolog
Brno, Czechia

Hôpital de l'Archet 2 (CHU de Nice)
Nice, Alpes-Maritimes, France

Hôpital Saint Louis (AP-HP)
Paris, Ile-de-France, France

Hôpital Necker - Enfants malades (AP-HP)
Paris, Ile-de-France, France

Hôpital de Clocheville (CHRU de Tours)
Tours, Indre-et-Loire, France

Hôpital de Brabois (CHU de Nancy)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France

Hôpital Charles Nicolle (CHU de Rouen)
Rouen, Seine-Maritime, France

University Hospital of Erlangen - ZSEER - Zentrum für Seltene Erkrankungen Erlangen
Erlangen, Bavaria, Germany

Städtisches Klinikum Dessau, Dessau Medical Center
Dessau, Sachsen-Anhalt, Germany

Istituto Dermopatico dell'Immacolata
Roma, Lazio, Italy

IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, Lombardia, Italy

Azienda USL Toscana Centro
Firenze, Toscana, Italy

Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, Lithuania

Contacts

Rébecca GENE
0144492582
rebecca.gene@aphp.fr

Anna GAROFANO
0144494443
anna.garofano@aphp.fr

Christine BODEMER, Principal Investigator
Hôpital Necker-Enfants Malades

Imagine Institute
NCT Number
Keywords
skin
MeSH Terms
Skin Diseases
Rare Diseases