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

NCT04451902 | Unknown

• 1 other identifier: COVID19-RareSkin
• Study Type: observational
• Target: 80
• Locations: 5 countries
• Sites: 13

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.

Conditions

Rare Diseases

Keywords

skin

Outcome Measures

Primary Outcomes (3)

• Analysis of the impact of COVID-19 infection on rare skin diseases: complications

  Frequency of hospitalisations related to suspected and confirmed cases of Covid-19 infection and consequences

  Baseline

• Analysis of the impact of COVID-19 infection on rare skin diseases: potential comorbidity factors

  Frequency of hospitalisations related to suspected and confirmed cases of Covid-19 infection and analysis of associated factors: age, gender, pathology, comorbidities, medications

  Baseline

• Analysis of the impact of COVID-19 infection on rare skin diseases: impact on the management of chronic conditions (change in treatment)

  Frequency of confirmed and suspected unconfirmed Covid-19 infections; description of clinical signs and signs of an impact on the chronic disease; description of possible therapeutic changes due to the Covid-19 infections

  Baseline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a European observational cohort study (research data) involving multiple centres whose main objective is to determine the impact of a COVID-19 virus infection in a cohort of patients with rare skin diseases and particularly if these rare diseases and their treatments are risk factors of infection severity. The cohort of patients with rare skin diseases is monitored by the European Reference Network (ERN-Skin) and FIMARAD network centres. This is a public health impact study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imagine Institute: lead

Study Sites (13)

University Hospital Brno - EB Centrum CR Dermatolog

Brno, 62501, Czechia

RECRUITING

Hôpital de l'Archet 2 (CHU de Nice)

Nice, Alpes-Maritimes, 06202, France

RECRUITING

Hôpital de Clocheville (CHRU de Tours)

Tours, Indre-et-Loire, 37000, France

RECRUITING

Hôpital de Brabois (CHU de Nancy)

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

RECRUITING

Hôpital Charles Nicolle (CHU de Rouen)

Rouen, Seine-Maritime, 76031, France

RECRUITING

Hôpital Saint Louis (AP-HP)

Paris, Île-de-France Region, 75010, France

RECRUITING

Hôpital Necker - Enfants malades (AP-HP)

Paris, Île-de-France Region, 75015, France

RECRUITING

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

Erlangen, Bavaria, 91054, Germany

RECRUITING

Städtisches Klinikum Dessau, Dessau Medical Center

Dessau, Saxony-Anhalt, 06847, Germany

RECRUITING

Istituto Dermopatico dell'Immacolata

Rome, Lazio, 00167, Italy

RECRUITING

IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

RECRUITING

Azienda USL Toscana Centro

Florence, Tuscany, 50122, Italy

RECRUITING

Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, 50010, Lithuania

RECRUITING

MeSH Terms

Conditions

Rare Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christine BODEMER

  Hôpital Necker-Enfants Malades

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rébecca GENE

CONTACT

0144492582; rebecca.gene@aphp.fr

Anna GAROFANO

CONTACT

0144494443; anna.garofano@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 30, 2020
• Study Start: June 30, 2020
• Primary Completion: April 30, 2022
• Study Completion: December 31, 2022
• Last Updated: September 2, 2021

Record last verified: 2021-09

Locations

LI (1); IT (3); FR (6); CZ (1); DE (2)