<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/NCT04469153</url>
  </required_header>
  <id_info>
    <org_study_id>2020_FerriGly COVID</org_study_id>
    <nct_id>NCT04469153</nct_id>
  </id_info>
  <brief_title>Interest of the Dosage of Ferritin / Glycosylated Ferritin in COVID-19</brief_title>
  <official_title>Interest of the Dosage of Ferritin / Glycosylated Ferritin in COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new coronavirus responsible&#xD;
      for the pandemic called coronavirus disease 2019 (COVID-19), which appeared in China in&#xD;
      December 2019 and which has spread rapidly around the world. Even if in the vast majority of&#xD;
      viral infection results in a mild illness, it can also progress to a severe form with&#xD;
      sometimes fatal consequences.&#xD;
&#xD;
      Indeed, clinical worsening, between the 7th and 10th days of the onset of symptoms, has been&#xD;
      widely described since the start of the pandemic. This manifests itself at the biological&#xD;
      level by hyperinflammation (VS, CRP, ferritin), coagulopathy (elevation of D-dimers,&#xD;
      sometimes disseminated intravascular coagulation) and cell lysis (CPK, LDH).&#xD;
&#xD;
      At the same time, it was observed high levels of pro-inflammatory cytokines (IL-1β, IL-6,&#xD;
      TNF-α, IL-18), suggestive of a cytokine storm, and the first studies on therapeutic&#xD;
      management targeting these cytokines are currently underway in COVID-19.&#xD;
&#xD;
      Such a profile strongly recalls on the one hand the cytokine release syndrome (CRS, observed&#xD;
      in CAR-T cell therapy in malignant hematology), and on the other hand the lymphohistiocytic&#xD;
      activation syndrome (SALH). Systemic diseases, such as adult Still's disease and its&#xD;
      pediatric side, can also be complicated by a cytokine storm, known as macrophagic activation&#xD;
      syndrome (SAM, equivalent to secondary SALH). Under all these conditions, IL-1β, IL-18, IFN-γ&#xD;
      and IL-6 seem to be key mediators of hyperinflammation.&#xD;
&#xD;
      Plasma ferritin is a biological marker of inflammation, long known, associated with various&#xD;
      infectious, hematological and immunological conditions. An increase in ferritin levels has in&#xD;
      particular been associated with an unfavorable development in certain infections such as&#xD;
      influenza and certain authors have moreover shown an association between plasma ferritin and&#xD;
      the evolution towards ARDS or death in patients. Its dosage is also used as a diagnostic tool&#xD;
      for SAM, and could make it possible to differentiate the latter from severe sepsis in&#xD;
      intensive care. Some authors have also noted it as a prognostic factor in Kawasaki disease or&#xD;
      CRS.&#xD;
&#xD;
      The plasma dosage of ferritin, associated with that of its glycosylated fraction, could&#xD;
      therefore be a diagnostic (difference between SAM and severe sepsis in intensive care),&#xD;
      prognostic (evolution towards ARDS, mutation in intensive care, mortality) and therapeutic&#xD;
      (indication of preemptive treatment with an inhibitor of IL-1 or IL6) in patients infected&#xD;
      with SARS-CoV-2.&#xD;
&#xD;
      The objective of this study is to retrospectively assess the prognostic value of ferritin and&#xD;
      glycosylated ferritin in SARS-CoV-2 infection in hospitalized.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>assessment of the prognostic value of ferritin in sars-cov2 positiv patients</measure>
    <time_frame>the time point is measured one time (biological analysis) at the beginning of the hospitalization ie: day 0 (retrospective analysis).</time_frame>
    <description>ferritin level will be assess by approved serological tests (French national medical authorities). Ferritin analysis is considered abnormal when the level is &gt; at 388 µg/L;</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">57</enrollment>
  <condition>the Prognostic Value of Ferritin</condition>
  <condition>Glycosylated Ferritin in SARS-CoV-2 Infection in Hospitalized COVID-19 Patients</condition>
  <arm_group>
    <arm_group_label>SARS-COV 2 positive patient</arm_group_label>
    <description>57 SARS-COV-2 positive patients followed during the SARS-COV 2 epidemic in the internal medicine department of the Croix-Rousse hospital. For each patient ferritin and glycosylated ferritin was analysed one time (biological analysis) at the entry of the hospitalization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests</intervention_name>
    <description>No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests</description>
    <arm_group_label>SARS-COV 2 positive patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient hospitalized in the internal medicine department of the Croix-Rousse hospital and&#xD;
        positive for the SARS-COV 2 (nasopharyngeal sample, the test was appoved by the French&#xD;
        national medical authorities).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient hospitalized in the internal medicine department of the Croix-Rousse hospital&#xD;
             and positive for the SARS-COV 2 (nasopharyngeal sample, the test was appoved by the&#xD;
             French national medical authorities).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not applicable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Maxime FAUTER</last_name>
    <phone>4 26 73 26 36</phone>
    <phone_ext>+33</phone_ext>
    <email>maxime.fauter@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yvan jamilloux</last_name>
    <phone>4 26 73 26 36</phone>
    <phone_ext>+33</phone_ext>
    <email>yvan.jamilloux@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>hopital de la Croix Rousse</name>
      <address>
        <city>Lyon 4</city>
        <state>Rhone Alpes</state>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yvan Jamilloux</last_name>
      <phone>4 26 73 26 36</phone>
      <phone_ext>+33</phone_ext>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Ferritin</keyword>
  <keyword>glycosylated ferritin</keyword>
  <keyword>prognostic factor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04469153
org study id: 2020_FerriGly COVID
nct id: NCT04469153
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new coronavirus responsible
      for the pandemic called coronavirus disease 2019 (COVID-19), which appeared in China in
      December 2019 and which has spread rapidly around the world. Even if in the vast majority of
      viral infection results in a mild illness, it can also progress to a severe form with
      sometimes fatal consequences.

      Indeed, clinical worsening, between the 7th and 10th days of the onset of symptoms, has been
      widely described since the start of the pandemic. This manifests itself at the biological
      level by hyperinflammation (VS, CRP, ferritin), coagulopathy (elevation of D-dimers,
      sometimes disseminated intravascular coagulation) and cell lysis (CPK, LDH).

      At the same time, it was observed high levels of pro-inflammatory cytokines (IL-1β, IL-6,
      TNF-α, IL-18), suggestive of a cytokine storm, and the first studies on therapeutic
      management targeting these cytokines are currently underway in COVID-19.

      Such a profile strongly recalls on the one hand the cytokine release syndrome (CRS, observed
      in CAR-T cell therapy in malignant hematology), and on the other hand the lymphohistiocytic
      activation syndrome (SALH). Systemic diseases, such as adult Still's disease and its
      pediatric side, can also be complicated by a cytokine storm, known as macrophagic activation
      syndrome (SAM, equivalent to secondary SALH). Under all these conditions, IL-1β, IL-18, IFN-γ
      and IL-6 seem to be key mediators of hyperinflammation.

      Plasma ferritin is a biological marker of inflammation, long known, associated with various
      infectious, hematological and immunological conditions. An increase in ferritin levels has in
      particular been associated with an unfavorable development in certain infections such as
      influenza and certain authors have moreover shown an association between plasma ferritin and
      the evolution towards ARDS or death in patients. Its dosage is also used as a diagnostic tool
      for SAM, and could make it possible to differentiate the latter from severe sepsis in
      intensive care. Some authors have also noted it as a prognostic factor in Kawasaki disease or
      CRS.

      The plasma dosage of ferritin, associated with that of its glycosylated fraction, could
      therefore be a diagnostic (difference between SAM and severe sepsis in intensive care),
      prognostic (evolution towards ARDS, mutation in intensive care, mortality) and therapeutic
      (indication of preemptive treatment with an inhibitor of IL-1 or IL6) in patients infected
      with SARS-CoV-2.

      The objective of this study is to retrospectively assess the prognostic value of ferritin and
      glycosylated ferritin in SARS-CoV-2 infection in hospitalized.
observational model: Cohort
time perspective: Retrospective
measure: assessment of the prognostic value of ferritin in sars-cov2 positiv patients
time frame: the time point is measured one time (biological analysis) at the beginning of the hospitalization ie: day 0 (retrospective analysis).
description: ferritin level will be assess by approved serological tests (French national medical authorities). Ferritin analysis is considered abnormal when the level is > at 388 µg/L;
arm group label: SARS-COV 2 positive patient
description: 57 SARS-COV-2 positive patients followed during the SARS-COV 2 epidemic in the internal medicine department of the Croix-Rousse hospital. For each patient ferritin and glycosylated ferritin was analysed one time (biological analysis) at the entry of the hospitalization.
intervention type: Other
intervention name: No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests
description: No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests
arm group label: SARS-COV 2 positive patient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maxime FAUTER
phone: 4 26 73 26 36
phone ext: +33
email: maxime.fauter@chu-lyon.fr
last name: Yvan jamilloux
phone: 4 26 73 26 36
phone ext: +33
email: yvan.jamilloux@chu-lyon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: COVID-19