COVID-19 and Rare Skin Diseases European Observational Study During an Epidemic

NCT ID: NCT04451902

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2022-12-31

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.

Conditions

Rare Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imagine Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine BODEMER

Role: PRINCIPAL_INVESTIGATOR

Hôpital Necker-Enfants Malades

Locations

University Hospital Brno - EB Centrum CR Dermatolog

Brno, , Czechia

Site Status: RECRUITING

Hôpital de l'Archet 2 (CHU de Nice)

Nice, Alpes-Maritimes, France

Site Status: RECRUITING

Hôpital de Clocheville (CHRU de Tours)

Tours, Indre-et-Loire, France

Site Status: RECRUITING

Hôpital de Brabois (CHU de Nancy)

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France

Site Status: RECRUITING

Hôpital Charles Nicolle (CHU de Rouen)

Rouen, Seine-Maritime, France

Site Status: RECRUITING

Hôpital Saint Louis (AP-HP)

Paris, Île-de-France Region, France

Site Status: RECRUITING

Hôpital Necker - Enfants malades (AP-HP)

Paris, Île-de-France Region, France

Site Status: RECRUITING

University Hospital of Erlangen - ZSEER - Zentrum für Seltene Erkrankungen Erlangen

Erlangen, Bavaria, Germany

Site Status: RECRUITING

Städtisches Klinikum Dessau, Dessau Medical Center

Dessau, Saxony-Anhalt, Germany

Site Status: RECRUITING

Istituto Dermopatico dell'Immacolata

Rome, Lazio, Italy

Site Status: RECRUITING

IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Site Status: RECRUITING

Azienda USL Toscana Centro

Florence, Tuscany, Italy

Site Status: RECRUITING

Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, , Lithuania

Site Status: RECRUITING

Countries

Czechia; France; Germany; Italy; Lithuania

Central Contacts

Rébecca GENE

Role: CONTACT

rebecca.gene@aphp.fr

0144492582

Anna GAROFANO

Role: CONTACT

anna.garofano@aphp.fr

0144494443

Facility Contacts

Hana Bučková, MD

Role: primary

Jocelyn Rapp, CRA

Role: primary

Emiliène Edée, CRA

Role: primary

Julie Boulanger, Resident

Role: primary

Marion Castel, MD

Role: primary

Hafsoiti Hassan Djohar, CRA

Role: primary

Anna Garofano, PhD

Role: primary

Holm Schneider, Prof.

Role: primary

Christos Zouboulis, Prof.

Role: primary

Biagio Didona, MD

Role: primary

Sophie Guez, MD

Role: primary

Marzia Caproni, Prof.

Role: primary

Agne Bubilaite, MD

Role: primary

Other Identifiers

COVID19-RareSkin

Identifier Type: -

Identifier Source: org_study_id