<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04451902</url>
  </required_header>
  <id_info>
    <org_study_id>COVID19-RareSkin</org_study_id>
    <nct_id>NCT04451902</nct_id>
  </id_info>
  <brief_title>COVID-19 and Rare Skin Diseases European Observational Study During an Epidemic</brief_title>
  <official_title>COVID-19 and Rare Skin Diseases. European Observational Study (Data Research) During an Epidemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imagine Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imagine Institute</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a European observational cohort study (data research) involving multiple centres to&#xD;
      look at the potential impact of COVID infection on patients with rare skin diseases examining&#xD;
      factors such as comorbidity, protection factors, and clinical and/or therapeutic factors. The&#xD;
      data collected may provide additional information on the situation of patients and, on a&#xD;
      wider basis, provide useful data applicable to the general population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Medical and demographic data will be collected from the medical records of patients. The data&#xD;
      required will be specified in Appendix 1 (collection form). Patients will be identified by&#xD;
      their initials (first letter of their surname and first name); The study will last for one&#xD;
      year to cover the COVID-19 epidemic in France (which includes the areas of mainland France&#xD;
      and its overseas departments and territories) and in Europe, via the ERN-Skin European&#xD;
      Network.&#xD;
&#xD;
      The frequency of severe forms of COVID-19 will be calculated with a bilateral 95% confidence&#xD;
      interval using, as a numerator, the number of patients with a severe form of COVID-19 and, as&#xD;
      a denominator, the number of patients with a COVID-19 diagnosis confirmed by PCR, chest scan,&#xD;
      serological assay or by suggestive clinical signs during the medical consultation. A severe&#xD;
      form of COVID is defined as a case requiring hospitalisation in an intensive care unit,&#xD;
      requiring resuscitation, or resulting in death.&#xD;
&#xD;
      Analysis of the impact of COVID-19 infection on rare skin diseases: complications, potential&#xD;
      comorbidity factors, impact on the management of chronic conditions (change in treatment) and&#xD;
      the experience of patients.&#xD;
&#xD;
      The results of the analysis may be compared with those obtained for other groups of diseases.&#xD;
      Gaining a better understanding of high-risk situations, as well as any aggravation or&#xD;
      protective factors, should enable us to issue recommendations adapted to this kind of disease&#xD;
      but that may also be useful for the general population. This type of study may also provide&#xD;
      &quot;reassurance&quot; to patients with rare diseases who have many questions during this period of&#xD;
      epidemic and heightened concern.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Analysis of the impact of COVID-19 infection on rare skin diseases: complications</measure>
    <time_frame>Baseline</time_frame>
    <description>Frequency of hospitalisations related to suspected and confirmed cases of Covid-19 infection and consequences</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analysis of the impact of COVID-19 infection on rare skin diseases: potential comorbidity factors</measure>
    <time_frame>Baseline</time_frame>
    <description>Frequency of hospitalisations related to suspected and confirmed cases of Covid-19 infection and analysis of associated factors: age, gender, pathology, comorbidities, medications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analysis of the impact of COVID-19 infection on rare skin diseases: impact on the management of chronic conditions (change in treatment)</measure>
    <time_frame>Baseline</time_frame>
    <description>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</description>
  </primary_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Rare Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This is a European observational cohort study (research data) involving multiple centres&#xD;
        whose main objective is to determine the impact of a COVID-19 virus infection in a cohort&#xD;
        of patients with rare skin diseases and particularly if these rare diseases and their&#xD;
        treatments are risk factors of infection severity. The cohort of patients with rare skin&#xD;
        diseases is monitored by the European Reference Network (ERN-Skin) and FIMARAD network&#xD;
        centres. This is a public health impact study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with a rare skin disease,&#xD;
&#xD;
          -  Patient of any age (paediatric or adult),&#xD;
&#xD;
          -  Patient with suspected COVID-19 infection (remote consultation, face-to-face&#xD;
             consultation, general practitioner, hospital physician),&#xD;
&#xD;
          -  Patient in contact with a subject infected with the COVID-19 virus,&#xD;
&#xD;
          -  Asymptomatic patient for COVID-19 viral infection but with a positive serology,&#xD;
&#xD;
          -  Study information given to the patient and/or to their legal representative,&#xD;
&#xD;
          -  Patient who has been informed and has agreed to this data collection process.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not suffering from a rare skin disease,&#xD;
&#xD;
          -  Patient and/or their legal representative who object to their participation in the&#xD;
             study at the presentation of the information leaflet,&#xD;
&#xD;
          -  Adult patient unable to understand the implications and constraints of the study,&#xD;
&#xD;
          -  Protected adult subject to guardianship or safeguarding measures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine BODEMER</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Necker-Enfants Malades</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rébecca GENE</last_name>
    <phone>0144492582</phone>
    <email>rebecca.gene@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anna GAROFANO</last_name>
    <phone>0144494443</phone>
    <email>anna.garofano@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Brno - EB Centrum CR Dermatolog</name>
      <address>
        <city>Brno</city>
        <zip>62501</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hana Bučková, MD</last_name>
    </contact>
    <investigator>
      <last_name>Hana Bučková, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital de l'Archet 2 (CHU de Nice)</name>
      <address>
        <city>Nice</city>
        <state>Alpes-Maritimes</state>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jocelyn Rapp, CRA</last_name>
    </contact>
    <investigator>
      <last_name>Christine Chiaverini, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Louis (AP-HP)</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hafsoiti Hassan Djohar, CRA</last_name>
    </contact>
    <investigator>
      <last_name>Emmanuelle Bourrat, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Necker - Enfants malades (AP-HP)</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Garofano, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Christine Bodemer, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital de Clocheville (CHRU de Tours)</name>
      <address>
        <city>Tours</city>
        <state>Indre-et-Loire</state>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emiliène Edée, CRA</last_name>
    </contact>
    <investigator>
      <last_name>Annabel Maruani, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital de Brabois (CHU de Nancy)</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <state>Meurthe-et-Moselle</state>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julie Boulanger, Resident</last_name>
    </contact>
    <investigator>
      <last_name>Anne-Claire Bursztejn, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Charles Nicolle (CHU de Rouen)</name>
      <address>
        <city>Rouen</city>
        <state>Seine-Maritime</state>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marion Castel, MD</last_name>
    </contact>
    <investigator>
      <last_name>Pascal Joly, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital of Erlangen - ZSEER - Zentrum für Seltene Erkrankungen Erlangen</name>
      <address>
        <city>Erlangen</city>
        <state>Bavaria</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Holm Schneider, Prof.</last_name>
    </contact>
    <investigator>
      <last_name>Holm Schneider, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Städtisches Klinikum Dessau, Dessau Medical Center</name>
      <address>
        <city>Dessau</city>
        <state>Sachsen-Anhalt</state>
        <zip>06847</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christos Zouboulis, Prof.</last_name>
    </contact>
    <investigator>
      <last_name>Christos Zouboulis, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Istituto Dermopatico dell'Immacolata</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00167</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Biagio Didona, MD</last_name>
    </contact>
    <investigator>
      <last_name>Biagio Didona, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IRCCS Ca' Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sophie Guez, MD</last_name>
    </contact>
    <investigator>
      <last_name>Sophie Guez, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda USL Toscana Centro</name>
      <address>
        <city>Firenze</city>
        <state>Toscana</state>
        <zip>50122</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marzia Caproni, Prof.</last_name>
    </contact>
    <investigator>
      <last_name>Marzia Caproni, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital of Lithuanian University of Health Sciences Kauno Klinikos</name>
      <address>
        <city>Kaunas</city>
        <zip>50010</zip>
        <country>Lithuania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Agne Bubilaite, MD</last_name>
    </contact>
    <investigator>
      <last_name>Skaidra Valiukevičienė, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Lithuania</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>September 1, 2021</last_update_submitted>
  <last_update_submitted_qc>September 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>skin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Diseases</mesh_term>
    <mesh_term>Rare Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04451902
org study id: COVID19-RareSkin
nct id: NCT04451902
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Other
measure: Analysis of the impact of COVID-19 infection on rare skin diseases: complications
time frame: Baseline
description: Frequency of hospitalisations related to suspected and confirmed cases of Covid-19 infection and consequences
measure: Analysis of the impact of COVID-19 infection on rare skin diseases: potential comorbidity factors
time frame: Baseline
description: Frequency of hospitalisations related to suspected and confirmed cases of Covid-19 infection and analysis of associated factors: age, gender, pathology, comorbidities, medications
measure: 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
description: 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
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Christine BODEMER
role: Principal Investigator
affiliation: Hôpital Necker-Enfants Malades
last name: Rébecca GENE
phone: 0144492582
email: rebecca.gene@aphp.fr
last name: Anna GAROFANO
phone: 0144494443
email: anna.garofano@aphp.fr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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country: Czechia
country: France
country: Germany
country: Italy
country: Lithuania
responsible party type: Sponsor
mesh term: Skin Diseases
mesh term: Rare Diseases