<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/NCT04412473</url>
  </required_header>
  <id_info>
    <org_study_id>7837</org_study_id>
    <nct_id>NCT04412473</nct_id>
  </id_info>
  <brief_title>COVID-19 Respiratory Distress and Antithrombotic Drugs in Subject's Habits</brief_title>
  <acronym>CRASH</acronym>
  <official_title>COVID-19 Respiratory Distress and Antithrombotic Drugs inSubject's Habits</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>
      Current management of VID-19 consists of oxygen support without specific treatment.&#xD;
      Hospitalization may suddenly require delayed resuscitation. This evolution corresponds to an&#xD;
      atypical acute respiratory distress syndrome (ARDS), the mechanism of which is poorly&#xD;
      understood and difficult to predict. The general pathophysiology of ARDS, the vascular&#xD;
      tropism of SARS-Cov2, the description of coagulopathy and numerous pulmonary artery&#xD;
      thromboses in resuscitation and the encouraging investigation of antithrombotics in general&#xD;
      ARDS&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 30, 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Analysis of Respiratory Distress and Antithrombolytic Therapy in Patients with covid19</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Sars-CoV2</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult Partients hospitalised in HUS or GHRMSA for COVID-19 with diagnosis COVID-19&#xD;
        confirmed by smear or evoked by CT scan or chest X-ray without a differential diagnosis&#xD;
        retained in the medical record&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major Subject (≥18 years)&#xD;
&#xD;
          -  Subject hospitalised in HUS or GHRMSA for COVID-19&#xD;
&#xD;
          -  The diagnosis COVID-19 confirmed by smear or evoked by CT scan or chest X-ray without&#xD;
             a differential diagnosis retained in the medical record&#xD;
&#xD;
          -  Subjects who, after being informed, do not wish to have their data reused for the&#xD;
             purposes of this research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject who expressed opposition to participating in the study&#xD;
&#xD;
          -  Subject under guardianship or trusteeship&#xD;
&#xD;
          -  Subject under safeguard of justice&#xD;
&#xD;
          -  Patient hospitalized in a geriatric service or in a ward not labeled COVID (surgery,&#xD;
             oncology,...) or in a short-term hospitalization unit without transfer to another&#xD;
             service.&#xD;
&#xD;
          -  Serious patient on admission to the emergency room and recused from resuscitation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Vincent CASTELAIN, MD, PhD</last_name>
    <phone>33 3 88 12 82 69</phone>
    <email>Vincent.CASTELAIN@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 Médecine Intensive et Réanimation</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincent CASTELAIN, MD, PhD</last_name>
      <phone>33 3 88 12 82 69 /</phone>
      <email>Vincent.CASTELAIN@chru-strasbourg.fr</email>
    </contact>
    <investigator>
      <last_name>Vincent CASTELAIN, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stanislas DEMUTH, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laurine LE GOFF, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Edouard TERRADE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bernard GOICHOT, 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 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>January 8, 2021</last_update_submitted>
  <last_update_submitted_qc>January 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sars-CoV2</keyword>
  <keyword>Covid-19</keyword>
  <keyword>Antithrombotic treatments</keyword>
  <keyword>ARDS</keyword>
  <keyword>Hypoxemia</keyword>
  <keyword>Thrombosis</keyword>
  <keyword>Pulmonary arteries</keyword>
  <keyword>Endothelial</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/NCT04412473
org study id: 7837
nct id: NCT04412473
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Current management of VID-19 consists of oxygen support without specific treatment.
      Hospitalization may suddenly require delayed resuscitation. This evolution corresponds to an
      atypical acute respiratory distress syndrome (ARDS), the mechanism of which is poorly
      understood and difficult to predict. The general pathophysiology of ARDS, the vascular
      tropism of SARS-Cov2, the description of coagulopathy and numerous pulmonary artery
      thromboses in resuscitation and the encouraging investigation of antithrombotics in general
      ARDS
observational model: Case-Only
time perspective: Retrospective
measure: Analysis of Respiratory Distress and Antithrombolytic Therapy in Patients with covid19
time frame: 1 month
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Vincent CASTELAIN, MD, PhD
phone: 33 3 88 12 82 69
email: Vincent.CASTELAIN@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: 
country: France
responsible party type: Sponsor
mesh term: COVID-19