Rare DiseasesNCT04451902
COVID-19 and Rare Skin Diseases European Observational Study During an Epidemic
An observational study of Rare Diseases, run by Imagine Institute at 13 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rare Diseases
- How many people
- 80 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 30 Jun 2020to 31 Dec 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
France6 sites, 6 recruiting
- Recruiting
Hôpital de l'Archet 2 (CHU de Nice)
Nice, Alpes-Maritimes, 06202
Jocelyn Rapp, CRA
Christine Chiaverini, MD
- Recruiting
Hôpital Saint Louis (AP-HP)
Paris, Île-de-France Region, 75010
Hafsoiti Hassan Djohar, CRA
Emmanuelle Bourrat, MD
- Recruiting
Hôpital Necker - Enfants malades (AP-HP)
Paris, Île-de-France Region, 75015
Anna Garofano, PhD
Christine Bodemer, Prof.
- Recruiting
Hôpital Charles Nicolle (CHU de Rouen)
Rouen, Seine-Maritime, 76031
Marion Castel, MD
Pascal Joly, Prof.
- Recruiting
Hôpital de Clocheville (CHRU de Tours)
Tours, Indre-et-Loire, 37000
Emiliène Edée, CRA
Annabel Maruani, Prof.
- Recruiting
Hôpital de Brabois (CHU de Nancy)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511
Julie Boulanger, Resident
Anne-Claire Bursztejn, MD
Italy3 sites, 3 recruiting
- Recruiting
Azienda USL Toscana Centro
Florence, Tuscany, 50122
Marzia Caproni, Prof.
Marzia Caproni, Prof.
- Recruiting
IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Sophie Guez, MD
Sophie Guez, MD
- Recruiting
Istituto Dermopatico dell'Immacolata
Rome, Lazio, 00167
Biagio Didona, MD
Biagio Didona, MD
Germany2 sites, 2 recruiting
- Recruiting
Städtisches Klinikum Dessau, Dessau Medical Center
Dessau, Saxony-Anhalt, 06847
Christos Zouboulis, Prof.
Christos Zouboulis, Prof.
- Recruiting
University Hospital of Erlangen - ZSEER - Zentrum für Seltene Erkrankungen Erlangen
Erlangen, Bavaria, 91054
Holm Schneider, Prof.
Holm Schneider, Prof.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Brno - EB Centrum CR Dermatolog
Brno, 62501
Hana Bučková, MD
Hana Bučková, MD
Lithuania1 site, 1 recruiting
- Recruiting
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, 50010
Agne Bubilaite, MD
Skaidra Valiukevičienė, Prof.
About this study
Official title: 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.
Read the 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.
- Conditions
- Rare Diseases
- Keywords
- skin
- Medical subject headings
- Rare Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start30 Jun 2020
- Primary completion30 Apr 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rare DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Imagine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine BODEMER, Principal investigator, Hôpital Necker-Enfants Malades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451902
- Sponsor's protocol ID
- COVID19-RareSkin
- Status last verified
- Sep 2021
- First submitted
- 23 Jun 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 and Rare Skin Diseases. European Observational Study (Data Research) During an Epidemic
- ClinicalTrials.gov ID
- NCT04451902
- Acronym / sponsor ID
- COVID19-RareSkin
- Conditions
- Rare Diseases
- Keywords
- skin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Imagine InstituteUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine BODEMER principal investigator
Hôpital Necker-Enfants Malades
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rare Diseases, run by Imagine Institute at 13 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Italy, Germany, Czechia, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rébecca GENE (0144492582, rebecca.gene@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the impact of COVID-19 infection on rare skin diseases: complications (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.