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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04451902
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
Imagine Institute

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: COVID-19 and Rare Skin Diseases. European Observational Study (Data Research) During an Epidemic
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Analysis of the impact of COVID-19 infection on rare skin diseases: complications [ Time Frame: Baseline ]
    Frequency of hospitalisations related to suspected and confirmed cases of Covid-19 infection and consequences

  2. Analysis of the impact of COVID-19 infection on rare skin diseases: potential comorbidity factors [ Time Frame: Baseline ]
    Frequency of hospitalisations related to suspected and confirmed cases of Covid-19 infection and analysis of associated factors: age, gender, pathology, comorbidities, medications

  3. Analysis of the impact of COVID-19 infection on rare skin diseases: impact on the management of chronic conditions (change in treatment) [ Time Frame: Baseline ]
    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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451902


Contacts
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Contact: Rébecca GENE 0144492582 rebecca.gene@aphp.fr
Contact: Anna GAROFANO 0144494443 anna.garofano@aphp.fr

Locations
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Czechia
University Hospital Brno - EB Centrum CR Dermatolog Recruiting
Brno, Czechia, 62501
Contact: Hana Bučková, MD         
Principal Investigator: Hana Bučková, MD         
France
Hôpital de l'Archet 2 (CHU de Nice) Recruiting
Nice, Alpes-Maritimes, France, 06202
Contact: Jocelyn Rapp, CRA         
Principal Investigator: Christine Chiaverini, MD         
Hôpital Saint Louis (AP-HP) Recruiting
Paris, Ile-de-France, France, 75010
Contact: Hafsoiti Hassan Djohar, CRA         
Principal Investigator: Emmanuelle Bourrat, MD         
Hôpital Necker - Enfants malades (AP-HP) Recruiting
Paris, Ile-de-France, France, 75015
Contact: Anna Garofano, PhD         
Principal Investigator: Christine Bodemer, Prof.         
Hôpital de Clocheville (CHRU de Tours) Recruiting
Tours, Indre-et-Loire, France, 37000
Contact: Emiliène Edée, CRA         
Principal Investigator: Annabel Maruani, Prof.         
Hôpital de Brabois (CHU de Nancy) Recruiting
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
Contact: Julie Boulanger, Resident         
Principal Investigator: Anne-Claire Bursztejn, MD         
Hôpital Charles Nicolle (CHU de Rouen) Recruiting
Rouen, Seine-Maritime, France, 76031
Contact: Marion Castel, MD         
Principal Investigator: Pascal Joly, Prof.         
Germany
University Hospital of Erlangen - ZSEER - Zentrum für Seltene Erkrankungen Erlangen Recruiting
Erlangen, Bavaria, Germany, 91054
Contact: Holm Schneider, Prof.         
Principal Investigator: Holm Schneider, Prof.         
Städtisches Klinikum Dessau, Dessau Medical Center Recruiting
Dessau, Sachsen-Anhalt, Germany, 06847
Contact: Christos Zouboulis, Prof.         
Principal Investigator: Christos Zouboulis, Prof.         
Italy
Istituto Dermopatico dell'Immacolata Recruiting
Roma, Lazio, Italy, 00167
Contact: Biagio Didona, MD         
Principal Investigator: Biagio Didona, MD         
IRCCS Ca' Granda Ospedale Maggiore Policlinico Recruiting
Milano, Lombardia, Italy, 20122
Contact: Sophie Guez, MD         
Principal Investigator: Sophie Guez, MD         
Azienda USL Toscana Centro Recruiting
Firenze, Toscana, Italy, 50122
Contact: Marzia Caproni, Prof.         
Principal Investigator: Marzia Caproni, Prof.         
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno Klinikos Recruiting
Kaunas, Lithuania, 50010
Contact: Agne Bubilaite, MD         
Principal Investigator: Skaidra Valiukevičienė, Prof.         
Sponsors and Collaborators
Imagine Institute
Investigators
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Principal Investigator: Christine BODEMER Hôpital Necker-Enfants Malades
More Information
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Responsible Party: Imagine Institute
ClinicalTrials.gov Identifier: NCT04451902    
Other Study ID Numbers: COVID19-RareSkin
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imagine Institute:
skin
Additional relevant MeSH terms:
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Skin Diseases
Rare Diseases
Disease Attributes
Pathologic Processes