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 centres to look at the potential impact of COVID infection on patients with rare skin diseases examining factors such as comorbidity, protection factors, and clinical and/or therapeutic factors. The data collected may provide additional information on the situation of patients and, on a wider basis, provide useful data applicable to the general 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.

Recruiting
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