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Characteristics and Outcomes of Patients Admitted to Swedish Intensive Care Units for COVID-19

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ClinicalTrials.gov Identifier: NCT04462393
Recruitment Status : Completed
First Posted : July 8, 2020
Last Update Posted : July 9, 2020
Sponsor:
Collaborator:
Region Östergötland
Information provided by (Responsible Party):
Michelle Chew, Linkoeping University

Brief Summary:

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 was 30-day all-cause mortality


Condition or disease Intervention/treatment
COVID-19 Critical Illness Other: Admission to ICU for COVID-19

Detailed Description:

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.

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.

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Study Type : Observational
Actual Enrollment : 1563 participants
Observational Model: Cohort
Time Perspective: Other
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
Actual Study Start Date : March 6, 2020
Actual Primary Completion Date : May 6, 2020
Actual Study Completion Date : May 6, 2020

Intervention Details:
  • Other: Admission to ICU for COVID-19
    All patients admitted to Swedish ICUs with COVID-19 between 6 Mar - 6 May 2020


Primary Outcome Measures :
  1. 30-day mortality [ Time Frame: 30 days ]
    all-cause


Secondary Outcome Measures :
  1. ICU mortality [ Time Frame: 30 days ]
    all cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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 (6 March-6May2020).

Criteria

Inclusion Criteria:

  • Adult patients (≥18 years)
  • COVID-19 disease

Exclusion Criteria:

  • No Swedish personal identity number
  • 'Opt out' from Swedish Intensive Care Registry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04462393


Locations
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Sweden
Department of Anaesthesia and Intensive Care, Linkoeping University Hospital, Region Östergötland
Linköping, Östergötland, Sweden, 50185
Sponsors and Collaborators
Linkoeping University
Region Östergötland
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Responsible Party: Michelle Chew, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT04462393    
Other Study ID Numbers: SweCOVID
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Unidentified data will be shared conditional upon application to the CI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes