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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rare Diseases

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Rébecca GENE; Phone Number: 0144492582; Email: rebecca.gene@aphp.fr
• Study Contact Backup: Name: Anna GAROFANO; Phone Number: 0144494443; Email: anna.garofano@aphp.fr

Study Locations

• Czechia
  • Brno, Czechia, 62501
    • Recruiting
    • University Hospital Brno - EB Centrum CR Dermatolog
    • Contact: Hana Bučková, MD
    • Principal Investigator: Hana Bučková, MD
• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06202
      • Recruiting
      • Hôpital de l'Archet 2 (CHU de Nice)
      • Contact: Jocelyn Rapp, CRA
      • Principal Investigator: Christine CHIAVERINI, MD
  • Ile-de-France
    • Paris, Ile-de-France, France, 75010
      • Recruiting
      • Hôpital Saint Louis (AP-HP)
      • Contact: Hafsoiti Hassan Djohar, CRA
    • Paris, Ile-de-France, France, 75015
      • Recruiting
      • Hôpital Necker - Enfants malades (AP-HP)
      • Contact: Anna Garofano, PhD
      • Principal Investigator: Christine Bodemer, Prof.
  • Indre-et-Loire
    • Tours, Indre-et-Loire, France, 37000
      • Recruiting
      • Hôpital de Clocheville (CHRU de Tours)
      • Contact: Emiliène Edée, CRA
      • Principal Investigator: Annabel Maruani, Prof.
  • Meurthe-et-Moselle
    • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
      • Recruiting
      • Hôpital de Brabois (CHU de Nancy)
      • Contact: Julie Boulanger, Resident
      • Principal Investigator: Anne-Claire Bursztejn, MD
  • Seine-Maritime
    • Rouen, Seine-Maritime, France, 76031
      • Recruiting
      • Hôpital Charles Nicolle (CHU de Rouen)
      • Contact: Marion Castel, MD
      • Principal Investigator: Pascal Joly, Prof.
• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • University Hospital of Erlangen - ZSEER - Zentrum für Seltene Erkrankungen Erlangen
      • Contact: Holm Schneider, Prof.
      • Principal Investigator: Holm Schneider, Prof.
  • Sachsen-Anhalt
    • Dessau, Sachsen-Anhalt, Germany, 06847
      • Recruiting
      • Städtisches Klinikum Dessau, Dessau Medical Center
      • Contact: Christos Zouboulis, Prof.
      • Principal Investigator: Christos Zouboulis, Prof.
• Italy
  • Lazio
    • Roma, Lazio, Italy, 00167
      • Recruiting
      • Istituto Dermopatico dell'Immacolata
      • Contact: Biagio Didona, MD
      • Principal Investigator: Biagio Didona, MD
  • Lombardia
    • Milano, Lombardia, Italy, 20122
      • Recruiting
      • IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Contact: Sophie Guez, MD
      • Principal Investigator: Sophie Guez, MD
  • Toscana
    • Firenze, Toscana, Italy, 50122
      • Recruiting
      • Azienda Usl Toscana Centro
      • Contact: Marzia Caproni, Prof.
      • Principal Investigator: Marzia Caproni, Prof.
• Lithuania
  • Kaunas, Lithuania, 50010
    • Recruiting
    • Hospital of Lithuanian University of Health Sciences Kauno klinikos
    • Contact: Agne Bubilaite, MD
    • Principal Investigator: Skaidra Valiukevičienė, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Imagine Institute
• Investigators: Principal Investigator: Christine BODEMER, Hôpital Necker-Enfants Malades

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2020
• Primary Completion (ANTICIPATED): April 30, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (ACTUAL): June 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: skin
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Skin Diseases; Rare Diseases
• Other Study ID Numbers: COVID19-RareSkin

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No