<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/NCT04474249</url>
  </required_header>
  <id_info>
    <org_study_id>EPM-2020-02697</org_study_id>
    <nct_id>NCT04474249</nct_id>
  </id_info>
  <brief_title>Follow-up of Critical COVID-19 Patients</brief_title>
  <acronym>FUP-COVID</acronym>
  <official_title>Uppföljning av Patienter Som intensivvårdats för COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uppsala University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Uppsala University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Uppsala University</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>
      The study will follow COVID-19 patients who required intensive care after 3-6 months and one&#xD;
      year after discharge from the ICU with functional level as well as organ function to assess&#xD;
      recovery after COVID-19. Blood and urine will be collected for biobanking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will follow COVID-19 patients who required intensive care at Uppsala University&#xD;
      Hospital and were included in the Uppsala COVID-19 biobank. The patients will be contacted&#xD;
      after three to six months for a first follow-up with assessment of functional level in&#xD;
      activities of daily life, psychiatric symptoms, neurological symptoms and working capacity as&#xD;
      well as specific organ functions. The organ functions will include circulation, respiration,&#xD;
      coagulation, immune function and kidney function. In addition, blood and urine will be&#xD;
      collected for biobanking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 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>Mortality</measure>
    <time_frame>Within 90 days after admission to ICU.</time_frame>
    <description>Death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>Within 1 year after admission to ICU.</time_frame>
    <description>Death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal recovery</measure>
    <time_frame>At follow-up three to six months after ICU discharge.</time_frame>
    <description>Return of renal function measured as CKD stage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal recovery</measure>
    <time_frame>At follow-up one year after ICU discharge.</time_frame>
    <description>Return of renal function measured as CKD stage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory recovery</measure>
    <time_frame>Three to six months from discharge from ICU</time_frame>
    <description>Respiratory function as assessed by a clinician</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Working capacity</measure>
    <time_frame>Three to six months from discharge from ICU</time_frame>
    <description>6 min walk test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life score</measure>
    <time_frame>Three to six months from discharge from ICU</time_frame>
    <description>Quality of Life assessed using the 36-item short form survey by RAND.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive recovery</measure>
    <time_frame>Three to six months from discharge from ICU</time_frame>
    <description>Cognitive screening using the Montreal Cognitive Assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frailty</measure>
    <time_frame>Three to six months from discharge from ICU</time_frame>
    <description>Screening for frailty using the Clinical Frailty Scale-9.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Activities of Daily Life</measure>
    <time_frame>Three to six months from discharge from ICU</time_frame>
    <description>Screening of functional level for Activities of Daily Life using the 5-level EQ-5D.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Three to six months from discharge from ICU</time_frame>
    <description>Screening for anxiety using the Generalised Anxiety Disorder 7-item scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression</measure>
    <time_frame>Three to six months from discharge from ICU</time_frame>
    <description>Screening for depression using the Patient Health Questionnaire 9.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurological recovery</measure>
    <time_frame>Three to six months from discharge from ICU</time_frame>
    <description>Neurological function as assessed by a clinician</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>COVID19</condition>
  <condition>ARDS</condition>
  <condition>AKI</condition>
  <condition>Circulatory Failure</condition>
  <condition>Coagulation Disorder</condition>
  <condition>Inflammatory Response</condition>
  <arm_group>
    <arm_group_label>COVID-19</arm_group_label>
    <description>Patients with PCR-confirmed COVID-19 who were treated in the intensive care unit.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine, Whole blood, Dried blood, Serum, EDTA-plasma, Citrate-plasma, cheek swab.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients admitted to ICU for COVID-19.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PCR-verified Covid-19&#xD;
&#xD;
          -  Treated in ICU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant of breastfeeding&#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>Michael Hultström, MD. PhD.</last_name>
    <phone>+46186110000</phone>
    <email>michael.hultstrom@mcb.uu.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Robert Frithiof, MD. PhD.</last_name>
    <phone>+46186110000</phone>
    <email>robert.frithiof@surgsci.uu.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Uppsala University Hospital</name>
      <address>
        <city>Uppsala</city>
        <zip>75185</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Hultström, MD. PhD.</last_name>
      <phone>+46186110000</phone>
      <email>michael.hultstrom@mcb.uu.se</email>
    </contact>
    <contact_backup>
      <last_name>Robert Frithiof, MD. PhD.</last_name>
      <phone>+46186110000</phone>
      <email>robert.frithiof@surgsci.uu.se</email>
    </contact_backup>
    <investigator>
      <last_name>Miklos Lipcsey, MD. PhD.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael Hultström, MD. PhD.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Robert Frithiof, MD. PhD.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sten Rubertsson, MD. PhD.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ewa Wallin, PhD.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ing-Marie Larsson, PhD.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <results_reference>
    <citation>E E, R F, Oi E, Im L, M L, S R, E W, C J, M H, A M. Impaired diffusing capacity for carbon monoxide is common in critically ill Covid-19 patients at four months post-discharge. Respir Med. 2021 Jun;182:106394. doi: 10.1016/j.rmed.2021.106394. Epub 2021 Apr 15.</citation>
    <PMID>33901787</PMID>
  </results_reference>
  <results_reference>
    <citation>Hultstrom M, Lipcsey M, Wallin E, Larsson IM, Larsson A, Frithiof R. Severe acute kidney injury associated with progression of chronic kidney disease after critical COVID-19. Crit Care. 2021 Jan 25;25(1):37. doi: 10.1186/s13054-021-03461-4. No abstract available.</citation>
    <PMID>33494766</PMID>
  </results_reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>October 18, 2021</last_update_submitted>
  <last_update_submitted_qc>October 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Corona virus</keyword>
  <keyword>Acute Kidney Injury</keyword>
  <keyword>SARS</keyword>
  <keyword>Vasopressor</keyword>
  <keyword>Respiratory failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data will be shared on reasonable request.</ipd_description>
  </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/NCT04474249
org study id: EPM-2020-02697
nct id: NCT04474249
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will follow COVID-19 patients who required intensive care after 3-6 months and one
      year after discharge from the ICU with functional level as well as organ function to assess
      recovery after COVID-19. Blood and urine will be collected for biobanking.
The study will follow COVID-19 patients who required intensive care at Uppsala University
      Hospital and were included in the Uppsala COVID-19 biobank. The patients will be contacted
      after three to six months for a first follow-up with assessment of functional level in
      activities of daily life, psychiatric symptoms, neurological symptoms and working capacity as
      well as specific organ functions. The organ functions will include circulation, respiration,
      coagulation, immune function and kidney function. In addition, blood and urine will be
      collected for biobanking.
observational model: Cohort
time perspective: Prospective
measure: Mortality
time frame: Within 90 days after admission to ICU.
description: Death
measure: Mortality
time frame: Within 1 year after admission to ICU.
description: Death
measure: Renal recovery
time frame: At follow-up three to six months after ICU discharge.
description: Return of renal function measured as CKD stage.
measure: Renal recovery
time frame: At follow-up one year after ICU discharge.
description: Return of renal function measured as CKD stage.
measure: Respiratory recovery
time frame: Three to six months from discharge from ICU
description: Respiratory function as assessed by a clinician
measure: Working capacity
time frame: Three to six months from discharge from ICU
description: 6 min walk test
measure: Quality of life score
time frame: Three to six months from discharge from ICU
description: Quality of Life assessed using the 36-item short form survey by RAND.
measure: Cognitive recovery
time frame: Three to six months from discharge from ICU
description: Cognitive screening using the Montreal Cognitive Assessment.
measure: Frailty
time frame: Three to six months from discharge from ICU
description: Screening for frailty using the Clinical Frailty Scale-9.
measure: Activities of Daily Life
time frame: Three to six months from discharge from ICU
description: Screening of functional level for Activities of Daily Life using the 5-level EQ-5D.
measure: Anxiety
time frame: Three to six months from discharge from ICU
description: Screening for anxiety using the Generalised Anxiety Disorder 7-item scale.
measure: Depression
time frame: Three to six months from discharge from ICU
description: Screening for depression using the Patient Health Questionnaire 9.
measure: Neurological recovery
time frame: Three to six months from discharge from ICU
description: Neurological function as assessed by a clinician
arm group label: COVID-19
description: Patients with PCR-confirmed COVID-19 who were treated in the intensive care unit.
Urine, Whole blood, Dried blood, Serum, EDTA-plasma, Citrate-plasma, cheek swab.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Hultström, MD. PhD.
phone: +46186110000
email: michael.hultstrom@mcb.uu.se
last name: Robert Frithiof, MD. PhD.
phone: +46186110000
email: robert.frithiof@surgsci.uu.se
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Sweden
citation: E E, R F, Oi E, Im L, M L, S R, E W, C J, M H, A M. Impaired diffusing capacity for carbon monoxide is common in critically ill Covid-19 patients at four months post-discharge. Respir Med. 2021 Jun;182:106394. doi: 10.1016/j.rmed.2021.106394. Epub 2021 Apr 15.
PMID: 33901787
citation: Hultstrom M, Lipcsey M, Wallin E, Larsson IM, Larsson A, Frithiof R. Severe acute kidney injury associated with progression of chronic kidney disease after critical COVID-19. Crit Care. 2021 Jan 25;25(1):37. doi: 10.1186/s13054-021-03461-4. No abstract available.
PMID: 33494766
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
mesh term: Shock
sharing ipd: Undecided
ipd description: Data will be shared on reasonable request.