<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/NCT04462393</url>
  </required_header>
  <id_info>
    <org_study_id>SweCOVID</org_study_id>
    <nct_id>NCT04462393</nct_id>
  </id_info>
  <brief_title>Characteristics and Outcomes of Patients Admitted to Swedish Intensive Care Units for COVID-19</brief_title>
  <official_title>Characteristics and Outcomes of Patients Admitted to Swedish Intensive Care Units for COVID-19 During the First 60 Days of the 2020 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Östergötland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Linkoeping 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>
      This is a registry-based cohort study of all adult patients (≥18 years) admitted to Swedish&#xD;
      Intensive Care Units with confirmed SARS-CoV-2 infection and COVID-19 disease during the&#xD;
      first 2 months of the 2020 pandemic.&#xD;
&#xD;
      The main goal is to describe demographic characteristics, coexisting conditions, treatments&#xD;
      and outcomes among critically ill patients with COVID-19. A secondary goal is to identify&#xD;
      independent risk factors associated with increased mortality for these patients.&#xD;
&#xD;
      Data regarding baseline characteristics including comorbidities, intensive care treatments&#xD;
      and outcomes will be extracted. ICU lengths of stay and 30-day mortalities will be&#xD;
      calculated. The primary outcome is 30-day all-cause mortality. THIS PART OF THE STUDY HAS&#xD;
      BEEN COMPLETED.&#xD;
&#xD;
      UPDATE 26 Feb 2022:&#xD;
&#xD;
      Characteristics and outcomes of 'first wave' patients admitted to Swedish ICUs was published&#xD;
      in Eur J Anaesthesiol. 2021 Apr 1;38(4):335-343. doi: 10.1097/EJA.0000000000001459.&#xD;
&#xD;
      A description of the surge response and aggregated data outcomes in Scandinavian countries&#xD;
      was published in https://onlinelibrary.wiley.com/doi/10.1111/aas.13983.&#xD;
&#xD;
      ADDITIONAL SUMMARY - EXTENDED INCLUSION PERIOD AND ADDITION OF LONG-TERM OUTCOMES Due to the&#xD;
      continued influx of patients requiring intensive care throughout 2020 and 2021, we extended&#xD;
      the inclusion period to 30 June 2021. Thus this new cohort will include all patients admitted&#xD;
      to ICUs in Sweden from 6 March 2020 to 30 June 2021.&#xD;
&#xD;
      We will investigate short (30day mortality) and long-term outcomes (365d mortality and&#xD;
      cardiovascular complications) of patients admitted to Swedish ICUs with confirmed SARS-CoV-2&#xD;
      infection and COVID-19 disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies reporting outcomes for COVID-19 patients admitted to intensive care units&#xD;
      (ICUs) have been hampered by right-censoring after short observation periods. None have&#xD;
      reported 30-day mortality rates and the vast majority of studies have substantial proportions&#xD;
      of undischarged patients at the time of follow-up. The lack of follow-up at least to ICU&#xD;
      discharge may cause bias in reported mortality rates. Further, national data on critically&#xD;
      ill patients have not been previously published.&#xD;
&#xD;
      UPDATE 26 Feb 2022: A number of large, cohort studies including national population outcomes&#xD;
      have now been published.&#xD;
&#xD;
      This is a registry-based cohort study of all adult patients (≥18 years) admitted to Swedish&#xD;
      Intensive Care Units with confirmed SARS-CoV-2 infection and COVID-19 disease during the&#xD;
      first 2 months of the 2020 pandemic. The Swedish Intensive Care Registry (SIR) collects data&#xD;
      on patients admitted to all Swedish ICUs, with 100% coverage since 2019. Thus, SIR is able to&#xD;
      report on outcomes in a national intensive care population without selection. Little is known&#xD;
      about the epidemiology of COVID-19 infections in Sweden, which has one of the world's highest&#xD;
      life expectancies and a significant burden of comorbidity. Coupled with Sweden's 'relaxed'&#xD;
      approach to COVID-19 pandemic management, health care outcomes are understandably under&#xD;
      question.&#xD;
&#xD;
      The main goal is to describe demographic characteristics, coexisting conditions, treatments&#xD;
      and outcomes among critically ill patients with COVID-19. A secondary goal is to identify&#xD;
      independent risk factors associated with increased mortality for these patients.&#xD;
&#xD;
      ADDITIONAL SUMMARY updated 20 October 2021 Due to the continued influx of COVID-19 patients&#xD;
      in ICUs in Sweden throughout 2020 and 2021, we extended of our sample size to encompass all&#xD;
      patients admitted up to 30 June 2021 (previously 6 May 2020).&#xD;
&#xD;
      We aim to investigate short- and long-term outcomes including mortality and the incidence of&#xD;
      new cardiovascular and respiratory diagnoses up to one year after inclusion.&#xD;
&#xD;
      On 22 mar 2021 we received ethical committee approval for these extensions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 6, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 6, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>30-day mortality</measure>
    <time_frame>30 days</time_frame>
    <description>all-cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>365-day mortality</measure>
    <time_frame>365 days (additional outcome added Oct 2021 after additional approval from ethical committee)</time_frame>
    <description>all-cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU mortality</measure>
    <time_frame>30 days</time_frame>
    <description>all cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>up to 365 days after study inclusion</time_frame>
    <description>Cardiovascular and Respiratory Diseases</description>
  </secondary_outcome>
  <enrollment type="Anticipated">7500</enrollment>
  <condition>COVID-19</condition>
  <condition>Critical Illness</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Admission to ICU for COVID-19</intervention_name>
    <description>All patients admitted to Swedish ICUs with COVID-19 between 6 Mar - 6 May 2020</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients (≥18 years)&#xD;
&#xD;
        admitted to Swedish Intensive Care Units with confirmed SARS-CoV-2 infection and COVID-19&#xD;
        disease during the first 2 months of the 2020 pandemic (6 March-6May2020).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (≥18 years)&#xD;
&#xD;
          -  COVID-19 disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No Swedish personal identity number&#xD;
&#xD;
          -  'Opt out' from Swedish Intensive Care Registry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anaesthesia and Intensive Care, Linkoeping University Hospital, Region Östergötland</name>
      <address>
        <city>Linköping</city>
        <state>Östergötland</state>
        <zip>50185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>February 26, 2022</last_update_submitted>
  <last_update_submitted_qc>February 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Linkoeping University</investigator_affiliation>
    <investigator_full_name>Michelle Chew</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Unidentified data will be shared conditional upon application to the CI</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/NCT04462393
org study id: SweCOVID
nct id: NCT04462393
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a registry-based cohort study of all adult patients (≥18 years) admitted to Swedish
      Intensive Care Units with confirmed SARS-CoV-2 infection and COVID-19 disease during the
      first 2 months of the 2020 pandemic.

      The main goal is to describe demographic characteristics, coexisting conditions, treatments
      and outcomes among critically ill patients with COVID-19. A secondary goal is to identify
      independent risk factors associated with increased mortality for these patients.

      Data regarding baseline characteristics including comorbidities, intensive care treatments
      and outcomes will be extracted. ICU lengths of stay and 30-day mortalities will be
      calculated. The primary outcome is 30-day all-cause mortality. THIS PART OF THE STUDY HAS
      BEEN COMPLETED.

      UPDATE 26 Feb 2022:

      Characteristics and outcomes of 'first wave' patients admitted to Swedish ICUs was published
      in Eur J Anaesthesiol. 2021 Apr 1;38(4):335-343. doi: 10.1097/EJA.0000000000001459.

      A description of the surge response and aggregated data outcomes in Scandinavian countries
      was published in https://onlinelibrary.wiley.com/doi/10.1111/aas.13983.

      ADDITIONAL SUMMARY - EXTENDED INCLUSION PERIOD AND ADDITION OF LONG-TERM OUTCOMES Due to the
      continued influx of patients requiring intensive care throughout 2020 and 2021, we extended
      the inclusion period to 30 June 2021. Thus this new cohort will include all patients admitted
      to ICUs in Sweden from 6 March 2020 to 30 June 2021.

      We will investigate short (30day mortality) and long-term outcomes (365d mortality and
      cardiovascular complications) of patients admitted to Swedish ICUs with confirmed SARS-CoV-2
      infection and COVID-19 disease.
Previous studies reporting outcomes for COVID-19 patients admitted to intensive care units
      (ICUs) have been hampered by right-censoring after short observation periods. None have
      reported 30-day mortality rates and the vast majority of studies have substantial proportions
      of undischarged patients at the time of follow-up. The lack of follow-up at least to ICU
      discharge may cause bias in reported mortality rates. Further, national data on critically
      ill patients have not been previously published.

      UPDATE 26 Feb 2022: A number of large, cohort studies including national population outcomes
      have now been published.

      This is a registry-based cohort study of all adult patients (≥18 years) admitted to Swedish
      Intensive Care Units with confirmed SARS-CoV-2 infection and COVID-19 disease during the
      first 2 months of the 2020 pandemic. The Swedish Intensive Care Registry (SIR) collects data
      on patients admitted to all Swedish ICUs, with 100% coverage since 2019. Thus, SIR is able to
      report on outcomes in a national intensive care population without selection. Little is known
      about the epidemiology of COVID-19 infections in Sweden, which has one of the world's highest
      life expectancies and a significant burden of comorbidity. Coupled with Sweden's 'relaxed'
      approach to COVID-19 pandemic management, health care outcomes are understandably under
      question.

      The main goal is to describe demographic characteristics, coexisting conditions, treatments
      and outcomes among critically ill patients with COVID-19. A secondary goal is to identify
      independent risk factors associated with increased mortality for these patients.

      ADDITIONAL SUMMARY updated 20 October 2021 Due to the continued influx of COVID-19 patients
      in ICUs in Sweden throughout 2020 and 2021, we extended of our sample size to encompass all
      patients admitted up to 30 June 2021 (previously 6 May 2020).

      We aim to investigate short- and long-term outcomes including mortality and the incidence of
      new cardiovascular and respiratory diagnoses up to one year after inclusion.

      On 22 mar 2021 we received ethical committee approval for these extensions.
observational model: Cohort
time perspective: Retrospective
measure: 30-day mortality
time frame: 30 days
description: all-cause
measure: 365-day mortality
time frame: 365 days (additional outcome added Oct 2021 after additional approval from ethical committee)
description: all-cause
measure: ICU mortality
time frame: 30 days
description: all cause
measure: Morbidity
time frame: up to 365 days after study inclusion
description: Cardiovascular and Respiratory Diseases
intervention type: Other
intervention name: Admission to ICU for COVID-19
description: All patients admitted to Swedish ICUs with COVID-19 between 6 Mar - 6 May 2020
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Linkoeping University
investigator full name: Michelle Chew
investigator title: Professor
mesh term: COVID-19
mesh term: Critical Illness
sharing ipd: Undecided
ipd description: Unidentified data will be shared conditional upon application to the CI