<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/NCT04456075</url>
  </required_header>
  <id_info>
    <org_study_id>CROWNLESS</org_study_id>
    <nct_id>NCT04456075</nct_id>
  </id_info>
  <brief_title>Risk Prediction and Therapy Monitoring in Patients With SARS-Cov-2 Infection / COVID 19</brief_title>
  <acronym>CROWNLESS</acronym>
  <official_title>Risk Prediction and Therapy Monitoring in Patients With SARS-Cov-2 Infection / COVID 19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heidelberg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heidelberg University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Approximately 15% of patients with SARS-CoV-2 infection / COVID-19 develop a severe clinical&#xD;
      course. This leads to hospitalization and potentially life threatening complications such as&#xD;
      pneumonia and respiratory failure. Predictors for early detection and risk stratification are&#xD;
      urgently needed. Moreover, only scarce information is available for long-term follow-up and&#xD;
      late complications associated with infection. We therefore aimed to find predictors for&#xD;
      severe courses of the novel disease as well as to establish strategies for therapeutic&#xD;
      monitoring and follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Anticipated">April 2022</completion_date>
  <primary_completion_date type="Anticipated">April 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>TLCO</measure>
    <time_frame>3-5 days intervals (inpatients)</time_frame>
    <description>Transfer factor for carbon monoxide</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TLCO</measure>
    <time_frame>1-6 months (outpatients, follow up)</time_frame>
    <description>Transfer factor for carbon monoxide</description>
  </primary_outcome>
  <primary_outcome>
    <measure>D5-20</measure>
    <time_frame>3-5 days intervals (inpatients</time_frame>
    <description>frequency dependence of resistance as measured by oscillometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>D5-20</measure>
    <time_frame>1-6 months (outpatients, follow up)</time_frame>
    <description>frequency dependence of resistance as measured by oscillometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FEV1/FVC</measure>
    <time_frame>3-5 days intervals (inpatients)</time_frame>
    <description>forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FEV1/FVC</measure>
    <time_frame>1-6 months (outpatients, follow up)</time_frame>
    <description>forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>comorbidities</measure>
    <time_frame>at hospital admission and each follow (every 1-6 months)</time_frame>
    <description>structured questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical symptoms</measure>
    <time_frame>3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)</time_frame>
    <description>structured qualitative questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>St. George's Respiratory Questionnaire total score</measure>
    <time_frame>3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)</time_frame>
    <description>validated questionnaire (scores range from 0 to 100, with higher scores indicating more limitations)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>SARS-CoV2</condition>
  <condition>COVID</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with SARS-CoV-2 infection / COVID 19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  SARS-CoV-2 infection / COVID 19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  invasive ventilation&#xD;
&#xD;
          -  respiratory failure at admission&#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_official>
    <last_name>Frederik Trinkmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thoraxklinik at Heidelberg University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Felix JF Herth, MD</last_name>
    <role>Study Director</role>
    <affiliation>Thoraxklinik at Heidelberg University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Frederik Trinkmann, MD</last_name>
    <phone>+49 6221 396</phone>
    <phone_ext>1201</phone_ext>
    <email>frederik.trinkmann@med.uni-heidelberg.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Thoraxklinik at Heidelberg University</name>
      <address>
        <city>Heidelberg</city>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Frederik Trinkmann, MD</last_name>
      <phone>+ 49 6221 396</phone>
      <phone_ext>1201</phone_ext>
      <email>frederik.trinkmann@med.uni-heidelberg.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Heidelberg University</investigator_affiliation>
    <investigator_full_name>Dr. Frederik Trinkmann</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT04456075
org study id: CROWNLESS
nct id: NCT04456075
lead sponsor: 
has dmc: Yes
Approximately 15% of patients with SARS-CoV-2 infection / COVID-19 develop a severe clinical
      course. This leads to hospitalization and potentially life threatening complications such as
      pneumonia and respiratory failure. Predictors for early detection and risk stratification are
      urgently needed. Moreover, only scarce information is available for long-term follow-up and
      late complications associated with infection. We therefore aimed to find predictors for
      severe courses of the novel disease as well as to establish strategies for therapeutic
      monitoring and follow-up.
observational model: Cohort
time perspective: Prospective
measure: TLCO
time frame: 3-5 days intervals (inpatients)
description: Transfer factor for carbon monoxide
measure: TLCO
time frame: 1-6 months (outpatients, follow up)
description: Transfer factor for carbon monoxide
measure: D5-20
time frame: 3-5 days intervals (inpatients
description: frequency dependence of resistance as measured by oscillometry
measure: D5-20
time frame: 1-6 months (outpatients, follow up)
description: frequency dependence of resistance as measured by oscillometry
measure: FEV1/FVC
time frame: 3-5 days intervals (inpatients)
description: forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)
measure: FEV1/FVC
time frame: 1-6 months (outpatients, follow up)
description: forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)
measure: comorbidities
time frame: at hospital admission and each follow (every 1-6 months)
description: structured questionnaire
measure: clinical symptoms
time frame: 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)
description: structured qualitative questionnaire
measure: St. George's Respiratory Questionnaire total score
time frame: 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)
description: validated questionnaire (scores range from 0 to 100, with higher scores indicating more limitations)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frederik Trinkmann, MD
role: Principal Investigator
affiliation: Thoraxklinik at Heidelberg University
last name: Felix JF Herth, MD
role: Study Director
affiliation: Thoraxklinik at Heidelberg University
last name: Frederik Trinkmann, MD
phone: +49 6221 396
phone ext: 1201
email: frederik.trinkmann@med.uni-heidelberg.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Heidelberg University
investigator full name: Dr. Frederik Trinkmann
investigator title: Principal Investigator
mesh term: COVID-19