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

Rare Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451902
• Other study ID #: COVID19-RareSkin
• Status: Recruiting
• Start date: June 30, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Imagine Institute
• Contact: Rébecca GENE
• Phone: 0144492582
• Email: rebecca.gene[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Rare Diseases
• Skin Diseases

Locations

Country	Name	City	State
Czechia	University Hospital Brno - EB Centrum CR Dermatolog	Brno
France	Hôpital de l'Archet 2 (CHU de Nice)	Nice	Alpes-Maritimes
France	Hôpital Necker - Enfants malades (AP-HP)	Paris	Ile-de-France
France	Hôpital Saint Louis (AP-HP)	Paris	Ile-de-France
France	Hôpital Charles Nicolle (CHU de Rouen)	Rouen	Seine-Maritime
France	Hôpital de Clocheville (CHRU de Tours)	Tours	Indre-et-Loire
France	Hôpital de Brabois (CHU de Nancy)	Vandœuvre-lès-Nancy	Meurthe-et-Moselle
Germany	Städtisches Klinikum Dessau, Dessau Medical Center	Dessau	Sachsen-Anhalt
Germany	University Hospital of Erlangen - ZSEER - Zentrum für Seltene Erkrankungen Erlangen	Erlangen	Bavaria
Italy	Azienda USL Toscana Centro	Firenze	Toscana
Italy	IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano	Lombardia
Italy	Istituto Dermopatico dell'Immacolata	Roma	Lazio
Lithuania	Hospital of Lithuanian University of Health Sciences Kauno Klinikos	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Imagine Institute

Countries where clinical trial is conducted

Czechia,  France,  Germany,  Italy,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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