Clinical trial NCT04426084: Cardiovascular Risk Factors and Severe COVID-19. A Nationwide Registry-based Case-Control Study
Official title: Cardiovascular Disease, Cardiovascular Risk Factors, Treatments and Severe COVID-19 Outcomes. A Nationwide Registry-based Case-Control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 22784
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 1,424 cases and 14,240 control subjects (first analysis june 2020) A total of 4684 cases and 46840 control subjects (july 2022)

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.

Eligibility criteria: 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).

Exclusion Criteria:

* No valid Swedish personal identity number (PIN)

Primary outcomes:
measure: Severe Covid-19
timeFrame: 2020-03-01 to 2020-05-11
measure: Severe Covid-19 with pulmonary embolism
timeFrame: 2020-03-01 to 2020-05-11
Secondary outcomes:
measure: CRRT(Continuous Renal Replacement Therapy)
timeFrame: 2020-03-01 to 2020-05-11
measure: ECMO (Extracorporeal Membrane Oxygenation )
timeFrame: 2020-03-01 to 2020-05-11
measure: ICU Mortality
timeFrame: 2020-03-01 to 2020-05-11
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
References:
citation: Svensson P, Hofmann R, Habel H, Jernberg T, Nordberg P. Association between cardiometabolic disease and severe COVID-19: a nationwide case-control study of patients requiring invasive mechanical ventilation. BMJ Open. 2021 Feb 17;11(2):e044486. doi: 10.1136/bmjopen-2020-044486.