COVID-19 & Rare Skin Diseases European Observational Study During an

Status Recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04451902
Study type	Observational [Patient Registry]
Source	Imagine Institute
Contact	Rébecca GENE
Phone	0144492582
Email	rebecca.gene@aphp.fr
Status	Recruiting
Phase
Start date	June 30, 2020
Completion date	December 31, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05794217` - A Multi-Site Leukopak Repository Providing Annotated Biospecimens for Approved Investigator-Directed Biomedical Research Initiatives
Completed	`NCT03680365` - Your Voice; Impact of Duchenne Muscular Dystrophy (DMD) on the Lives of Families
Completed	`NCT03290469` - NICUSeq: A Trial to Evaluate the Clinical Utility of Human Whole Genome Sequencing (WGS) Compared to Standard of Care in Acute Care Neonates and Infants	N/A
Not yet recruiting	`NCT05955794` - Vocal Pattern Assessment as a New Key to Identifying Rare Syndromes	N/A
Recruiting	`NCT04429750` - Intact Cord Resuscitation in CDH	N/A
Not yet recruiting	`NCT04152876` - Functional Genomics of Rare Genetic Diseases: Realization of Innovative Tools With High Diagnostic Power
Recruiting	`NCT03683966` - MigALastat Therapy Adherence Among FABRY Patients: A Prospective Multicentral Observational Study
Not yet recruiting	`NCT04319796` - European Registry on Rare Neurological Diseases
Completed	`NCT02736565` - Pbi-shRNA™ EWS/FLI1 Type 1 LPX in Subjects With Advanced Ewing's Sarcoma	Phase 1
Completed	`NCT05070988` - Oral Health Related Quality of Life of Patients With Rare Diseases: a Qualitative Approach
Completed	`NCT03563677` - Dual Guidance Structure for Evaluation of Patients With Unclear Diagnosis in Centers for Rare Diseases	N/A
Recruiting	`NCT05499091` - Functional Study to Indentify Genetic Etiology of Rare Diseases - ORIGIN	N/A
Completed	`NCT03954652` - Whole Genome Trio Sequencing as a Standard Routine Test in Patients With Rare Diseases - "GENOME FIRST APPROACH"	N/A
Recruiting	`NCT05703893` - Investigation of the Neurovegetative Pattern in Patients With Thoracic Aortic Aneurysms (TAA)
Enrolling by invitation	`NCT04703179` - Rare and Undiagnosed Disease Research Biorepository
Recruiting	`NCT04024774` - Diagnostic Research in Patients With Rare Diseases -Solving the Unsolved Rare Diseases
Recruiting	`NCT06343558` - Gait and Balance Impairment in Rare and Very Rare Neurological Diseases
Not yet recruiting	`NCT06412718` - Validation of Human Drugs Target of Repurposed Drugs and Novel Therapies
Enrolling by invitation	`NCT04654000` - Rheopheresis as Adjuvant Treatment of Calciphylaxis	N/A
Recruiting	`NCT04651439` - Severe Bullous Drug Eruption and Filgrastim	Phase 2/Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms