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

NCT ID: NCT04426084

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 22784 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2023-12-31

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.

Conditions

COVID-19

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Interventions

Hypertension

Exposure : Any registered diagnosis of I10 within 15 years or a registered pick-up of a prescription of antihypertensive treatment (ATC C02CA, C02DB02, C03, C07, C08, C09) within one year before index date in the Swedish prescribed drug register (exluding those with a registered diagnosis of other indications for betablocker (heart failure, atrial fibrillation) or ACE-inhibitor, ARB(heart failure) ) Exposures will be compared between cases and controls and between cases with different outcomes and controls

Intervention Type: OTHER

Diabetes type 2

Exposure: Any registered diagnosis of E11 within 15 years or a registered pick-up of a prescription with any antidiabetic treatment (ATC A10) within one year before index date in the Swedish prescribed drug register.

Exposures will be compared between cases and controls and between cases with different outcomes and controls

Intervention Type: OTHER

Obesity

Exposure: Diagnosis ICD E66 within 15 years before index date Exposures will be compared between cases and controls and between cases with different outcomes and controls

Intervention Type: OTHER

Antihypertensive Agents

Pick up of a prescription of C02CA, C02DB02, C03, C07, C08, C09 registered in the Swedish prescribed drug register within 6 month before index date.

Exposures will be studied separately for each antihypertensive class and compared between cases and controls and between cases with different outcomes and controls

Intervention Type: DRUG

Statins (Cardiovascular Agents)

Pick up of a prescription of C10AA registered in the Swedish prescribed drug register within 6 month before index date.

Intervention Type: DRUG

Chronic kidney disease

Exposure: Diagnosis ICD N18 within 15 years before index date Exposures will be compared between cases and controls and between cases with different outcomes (mechanical ventilation, continuous renal replacement therapy mortality) and controls. Exposures will thereafter be compared in subgroups by BMI at ICU-admission and in subgroups matched by history of type 2 diabetes.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Per Svensson

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Södersjukhuset

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 33597145 (View on PubMed)

Other Identifiers

4

Identifier Type: -

Identifier Source: org_study_id