<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/NCT04405726</url>
  </required_header>
  <id_info>
    <org_study_id>7760</org_study_id>
    <nct_id>NCT04405726</nct_id>
  </id_info>
  <brief_title>Prognostic Factors of COVID19</brief_title>
  <acronym>Covid-HUS</acronym>
  <official_title>Study of Clinical, Biological and Genetic Prognostic Factors of SARS-CoV-2 Infection in Patients Admitted in the Strasbourg University Hospitals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      COVID-19 is an emerging disease, for which no specific treatment options are currently&#xD;
      available. Since the end of February 2020, and due to a SARS-CoV-2 superspreading event&#xD;
      (religious meeting), the Strasbourg University Hospital (HUS) had faced a sudden increase of&#xD;
      the number of COVID-19-positive patients in serious condition requiring hospitalization. At&#xD;
      the same time, many people develop only mild or moderate symptoms. To date, the prognostic&#xD;
      factors for the course of SARS-CoV-2 infection are unknown. The primary purpose of the&#xD;
      &quot;COVID-HUS&quot; protocol is to investigate viral and host-related factors to understand the&#xD;
      pathophysiology of COVID infection and to open the way for new diagnostic, prognostic and&#xD;
      therapeutic strategies against SARS CoV-2 .&#xD;
&#xD;
      The secondary objectives are&#xD;
&#xD;
        -  Monitoring of viral replication of SARS-CoV-2 in the blood and respiratory tract in&#xD;
           infected patients&#xD;
&#xD;
        -  Monitoring of the humoral and cellular response directed against SARS-CoV-2&#xD;
&#xD;
        -  Identification of factors leading to significant and / or prolonged viral replication of&#xD;
           SARS-CoV-2 in the blood or respiratory samples&#xD;
&#xD;
        -  Evaluation of the benefit of possible treatments implemented following the diagnosis of&#xD;
           SARS-CoV-2 infection&#xD;
&#xD;
        -  Exploration of the B and T immune repertoire sequences targeting SARS-CoV-2 in infected&#xD;
           patients&#xD;
&#xD;
        -  Typing of the HLA system in infected patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 27, 2020</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">March 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Presentation and Incidence of Covid-19 Infection in patients hospitalised in Strasbourg Hospital</measure>
    <time_frame>From 1st March 2020 to 1st March 2021</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>SARS-CoV-2</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult and pediatric with suspicion or a confirmed SARS-CoV-2 infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult and pediatric with suspicion or a confirmed SARS-CoV-2 infection&#xD;
&#xD;
          -  Patient who has signed a non-opposition form (or a form signed by a family member or a&#xD;
             support person if the seriousness of the patient's condition and the emergency&#xD;
             situation do not allow it) or who has given his oral agreement to the doctor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient's explicit refusal to participate&#xD;
&#xD;
          -  Subject deprived of liberty or subject to the protection of justice&#xD;
&#xD;
          -  Subject under guardianship or trusteeship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samira FAFI-KREMER, PharmD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Laboratoire de Virologie Plateau Technique de Microbiologie</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Samira FAFI-KREMER, PharmD, PhD</last_name>
    <phone>33.3.69.55.14.38</phone>
    <email>Samira.fafi-kremer@chru-strasbourg.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Saïd CHAYER, PhD, HDR</last_name>
    <phone>33 3 88 11 66 90</phone>
    <email>said.chayer@chru-strasbourg.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service de Virologie - Hôpital Civil</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samira FAFI-KREMER, PharmD, PhD</last_name>
      <phone>33.3.69.55.14.38</phone>
      <email>Samira.fafi-kremer@chru-strasbourg.fr</email>
    </contact>
    <investigator>
      <last_name>Samira FAFI-KREMER, PharmD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yves HANSMANN, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Floriane GALLAIS, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ilies BENOTMANE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Héloïse DELAGREVERIE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Morgane SOLIS, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eric SOULIER, InG</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nicolas LEFEBVRE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>François DANION, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yvon RUCH, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nicolas MEYER, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aurélie VELAY, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Covid-19</keyword>
  <keyword>Prognostic factors</keyword>
  <keyword>Genetic factors</keyword>
  <keyword>T and B cell immune response</keyword>
  <!-- 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/NCT04405726
org study id: 7760
nct id: NCT04405726
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
COVID-19 is an emerging disease, for which no specific treatment options are currently
      available. Since the end of February 2020, and due to a SARS-CoV-2 superspreading event
      (religious meeting), the Strasbourg University Hospital (HUS) had faced a sudden increase of
      the number of COVID-19-positive patients in serious condition requiring hospitalization. At
      the same time, many people develop only mild or moderate symptoms. To date, the prognostic
      factors for the course of SARS-CoV-2 infection are unknown. The primary purpose of the
      "COVID-HUS" protocol is to investigate viral and host-related factors to understand the
      pathophysiology of COVID infection and to open the way for new diagnostic, prognostic and
      therapeutic strategies against SARS CoV-2 .

      The secondary objectives are

        -  Monitoring of viral replication of SARS-CoV-2 in the blood and respiratory tract in
           infected patients

        -  Monitoring of the humoral and cellular response directed against SARS-CoV-2

        -  Identification of factors leading to significant and / or prolonged viral replication of
           SARS-CoV-2 in the blood or respiratory samples

        -  Evaluation of the benefit of possible treatments implemented following the diagnosis of
           SARS-CoV-2 infection

        -  Exploration of the B and T immune repertoire sequences targeting SARS-CoV-2 in infected
           patients

        -  Typing of the HLA system in infected patients
observational model: Case-Only
time perspective: Other
measure: Clinical Presentation and Incidence of Covid-19 Infection in patients hospitalised in Strasbourg Hospital
time frame: From 1st March 2020 to 1st March 2021
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
last name: Samira FAFI-KREMER, PharmD, PhD
role: Study Director
affiliation: Laboratoire de Virologie Plateau Technique de Microbiologie
last name: Samira FAFI-KREMER, PharmD, PhD
phone: 33.3.69.55.14.38
email: Samira.fafi-kremer@chru-strasbourg.fr
last name: Saïd CHAYER, PhD, HDR
phone: 33 3 88 11 66 90
email: said.chayer@chru-strasbourg.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor