<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/NCT04401163</url>
  </required_header>
  <id_info>
    <org_study_id>33510</org_study_id>
    <nct_id>NCT04401163</nct_id>
  </id_info>
  <brief_title>Long-term Pulmonary Outcomes After Infection With Sars-CoV-2</brief_title>
  <official_title>Long-term Pulmonary Outcomes After Infection With Sars-CoV-2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</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>
      The objective of this study is to assess the long-term outcomes after hospital admission with&#xD;
      Covid-19 with respect to pulmonary function, physical capacity, imaging, quality of life and&#xD;
      socioeconomic outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be invited to follow-up visits 3 and 12 months after hospitalization with&#xD;
      COVID19.&#xD;
&#xD;
      Inclusion will take place during 2020. We expect to enroll 180 non-ICU patients and 36 ICU&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Actual">August 1, 2022</completion_date>
  <primary_completion_date type="Actual">October 1, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Imaging of the lungs</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>Expert evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Imaging of the lungs</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>Expert evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulmonary function tests</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>Liter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulmonary function tests</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>Liter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Six-minute walk test</measure>
    <time_frame>Performed 3 months after discharge</time_frame>
    <description>Walking distance (meters) and change in oxygen saturation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Six-minute walk test</measure>
    <time_frame>Performed 12 months after discharge</time_frame>
    <description>Walking distance (meters) and change in oxygen saturation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Form-36 (SF-36) questionnaire</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>0-100 scale. The lower the score, the more disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form-36 (SF-36) questionnaire</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>0-100 scale. The lower the score, the more disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Assessment Score</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>10-50 score. The higher the score, the more fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Assessment Score</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>10-50 score. The higher the score, the more fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive sore (MOCA)</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>0-30. The lower the score, the more cognitive impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive sore (MOCA)</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>0-30. The lower the score, the more cognitive impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital anxiety and Depression score (HADS)</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>0-21. The higher the score, the more risk of anxiety or depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital anxiety and Depression score (HADS)</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>0-21. The higher the score, the more risk of anxiety or depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comorbidities</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>Any pre-COVID-19 comorbidity and treatment with immmunosuppressants will be registered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood sample at routine follow up.</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>Change in outcomes between discharge and follow-up visits will be evaluated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood sample at routine follow up.</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>Change in outcomes between discharge and follow-up visits will be evaluated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biobanking of blood</measure>
    <time_frame>3 months after discharge</time_frame>
    <description>Knowledge regarding COVID19 is drastically evolving. Biobanking makes it possible to investigate blood samples in the future corresponding to ongoing evidence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biobanking of blood</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>Knowledge regarding COVID19 is drastically evolving. Biobanking makes it possible to investigate blood samples in the future corresponding to ongoing evidence.</description>
  </secondary_outcome>
  <enrollment type="Actual">218</enrollment>
  <condition>Sars-CoV2</condition>
  <condition>Covid19</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Imaging of the lungs</intervention_name>
    <description>After hospital admissions with COVID19 patients will come for two clinical visits to complete a number of questionnaires, pulmonary function testing, six-minute walk test, blood sampling and imaging of the lungs.</description>
    <other_name>Blood sampling</other_name>
    <other_name>Health related quality of life measurements</other_name>
    <other_name>Pulmonary function tests</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients hospitalized due to infection with Covid-19 and submitted from any of the five&#xD;
        hospitals in the Central Denmark Region will be invited to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infection with Sars-CoV-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to attend hospital visits due to frailty or severe disease&#xD;
&#xD;
          -  Unable to understand and complete questionnaires due to intellectual or language&#xD;
             limitations / deficits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Elisabeth Bendstrup, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Hospital, Holstebro</name>
      <address>
        <city>Holstebro</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Hospital, Horsens</name>
      <address>
        <city>Horsens</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Hospital, Randers</name>
      <address>
        <city>Randers</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Hospital, Silkeborg</name>
      <address>
        <city>Silkeborg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Hospital, Viborg</name>
      <address>
        <city>Viborg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04401163
org study id: 33510
nct id: NCT04401163
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to assess the long-term outcomes after hospital admission with
      Covid-19 with respect to pulmonary function, physical capacity, imaging, quality of life and
      socioeconomic outcomes.
Patients will be invited to follow-up visits 3 and 12 months after hospitalization with
      COVID19.

      Inclusion will take place during 2020. We expect to enroll 180 non-ICU patients and 36 ICU
      patients.
observational model: Cohort
time perspective: Prospective
measure: Imaging of the lungs
time frame: 3 months after discharge
description: Expert evaluation
measure: Imaging of the lungs
time frame: 12 months after discharge
description: Expert evaluation
measure: Pulmonary function tests
time frame: 3 months after discharge
description: Liter
measure: Pulmonary function tests
time frame: 12 months after discharge
description: Liter
measure: Six-minute walk test
time frame: Performed 3 months after discharge
description: Walking distance (meters) and change in oxygen saturation.
measure: Six-minute walk test
time frame: Performed 12 months after discharge
description: Walking distance (meters) and change in oxygen saturation.
measure: Short Form-36 (SF-36) questionnaire
time frame: 3 months after discharge
description: 0-100 scale. The lower the score, the more disability.
measure: Short Form-36 (SF-36) questionnaire
time frame: 12 months after discharge
description: 0-100 scale. The lower the score, the more disability.
measure: Fatigue Assessment Score
time frame: 3 months after discharge
description: 10-50 score. The higher the score, the more fatigue
measure: Fatigue Assessment Score
time frame: 12 months after discharge
description: 10-50 score. The higher the score, the more fatigue
measure: Cognitive sore (MOCA)
time frame: 3 months after discharge
description: 0-30. The lower the score, the more cognitive impairment
measure: Cognitive sore (MOCA)
time frame: 12 months after discharge
description: 0-30. The lower the score, the more cognitive impairment
measure: Hospital anxiety and Depression score (HADS)
time frame: 3 months after discharge
description: 0-21. The higher the score, the more risk of anxiety or depression.
measure: Hospital anxiety and Depression score (HADS)
time frame: 12 months after discharge
description: 0-21. The higher the score, the more risk of anxiety or depression.
measure: Comorbidities
time frame: 12 months after discharge
description: Any pre-COVID-19 comorbidity and treatment with immmunosuppressants will be registered.
measure: Blood sample at routine follow up.
time frame: 3 months after discharge
description: Change in outcomes between discharge and follow-up visits will be evaluated
measure: Blood sample at routine follow up.
time frame: 12 months after discharge
description: Change in outcomes between discharge and follow-up visits will be evaluated
measure: Biobanking of blood
time frame: 3 months after discharge
description: Knowledge regarding COVID19 is drastically evolving. Biobanking makes it possible to investigate blood samples in the future corresponding to ongoing evidence.
measure: Biobanking of blood
time frame: 12 months after discharge
description: Knowledge regarding COVID19 is drastically evolving. Biobanking makes it possible to investigate blood samples in the future corresponding to ongoing evidence.
intervention type: Diagnostic Test
intervention name: Imaging of the lungs
description: After hospital admissions with COVID19 patients will come for two clinical visits to complete a number of questionnaires, pulmonary function testing, six-minute walk test, blood sampling and imaging of the lungs.
other name: Blood sampling
other name: Health related quality of life measurements
other name: Pulmonary function tests
Whole blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
last name: Elisabeth Bendstrup, MD, PhD
role: Principal Investigator
affiliation: Aarhus University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Infections
sharing ipd: Undecided