COVID-19 and Rare Skin Diseases European Observational Study During an Epidemic
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ClinicalTrials.gov Identifier: NCT04451902 |
Recruitment Status :
Recruiting
First Posted : June 30, 2020
Last Update Posted : September 2, 2021
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Condition or disease |
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Rare Diseases |
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 [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 |

- 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
- 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
- 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

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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 |
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.

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
Contact: Rébecca GENE | 0144492582 | rebecca.gene@aphp.fr | |
Contact: Anna GAROFANO | 0144494443 | anna.garofano@aphp.fr |
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. |
Principal Investigator: | Christine BODEMER | Hôpital Necker-Enfants Malades |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
skin |
Skin Diseases Rare Diseases Disease Attributes Pathologic Processes |