Cardiovascular Risk Factors and Severe COVID-19. A Nationwide Registry-based Case-Control Study

• Conditions: COVID-19

• Registration Number: NCT04426084
• Lead Sponsor: Karolinska Institutet

Brief Summary

In this study we cross-reference several nationwide high-quality Swedish registers in order to study risk factors for severe Covid-19 outcomes.

Detailed Description

In this nationwide, case-control study we cross-reference several detailed, high-quality Swedish registers in order to study risk factors associated with severe Covid-19 as well as different disease outcomes, with a focus on cardiovascular disease, chronic kidney disease, different treatments and socioeconomic factors. Cases are identified through the Swedish intensive care register (SIR) and controls through the Swedish population register (RTB). Further information on the study participants is gathered by linkage to registers on: prescribed drugs; history of in- and outpatient care; income, education and migration. Follow-up data such as future hospitalization and mortality will be gathered prospectively.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Primary Completion: 2021-06-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-29
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22784

Inclusion Criteria

• Cases: Admitted to intensive care unit in Sweden and registered admission in the Swedish intensive care register (SIR) with a main diagnosis of Covid-19 confirmed by laboratory testing (ICD10: U07.1). (cases)
• Control subjects matched for age, gender,residency: For each case 10 controls matched for age, gender and district of residence will be identified by Statistics Sweden (SCB) in the Swedish population register (RTB).
• Control subjects matched for age and gender: For each case 5 controls matched for age and gender will be identified by by Statistics Sweden (SCB) in the Swedish population register (RTB).

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Exclusion Criteria

• No valid Swedish personal identity number (PIN)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severe Covid-19	2020-03-01 to 2020-05-11	Admitted to ICU in Sweden with a main diagnosis of Covid-19 confirmed by laboratory testing (ICD 10: U07.1) and requring mechanical ventilation
Severe Covid-19 with pulmonary embolism	2020-03-01 to 2020-05-11	Admitted to ICU in Sweden with a diagnosis of Covid-19 confirmed by laboratory testing (ICD 10: U07.1) and a bidiagnosis of pulmonary embolism (ICD10:I26)

Secondary Outcome Measures

Name	Time	Method
ICU Mortality	2020-03-01 to 2020-05-11	Number of participants admitted to ICU in Sweden with a verified diagnosis of Covid-19 with death occurring in ICU after admission
CRRT(Continuous Renal Replacement Therapy)	2020-03-01 to 2020-05-11	Number of participants admitted to ICU in Sweden with a verified diagnosis of Covid-19 requring CRRT
ECMO (Extracorporeal Membrane Oxygenation )	2020-03-01 to 2020-05-11	Number of participants admitted to ICU in Sweden with a verified diagnosis of Covid-19 requring ECMO

Trial Locations

Locations (1)

Södersjukhuset; 🇸🇪 Stockholm, Sweden