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

NCT04426084 | Unknown

• 1 other identifier: 4
• Study Type: observational
• Target: 22,784
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Severe Covid-19

  Admitted to ICU in Sweden with a main diagnosis of Covid-19 confirmed by laboratory testing (ICD 10: U07.1) and requring mechanical ventilation

  2020-03-01 to 2020-05-11

• Severe Covid-19 with pulmonary embolism

  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)

  2020-03-01 to 2020-05-11

Secondary Outcomes (3)

• CRRT(Continuous Renal Replacement Therapy)

  2020-03-01 to 2020-05-11

• ECMO (Extracorporeal Membrane Oxygenation )

  2020-03-01 to 2020-05-11

• ICU Mortality

  2020-03-01 to 2020-05-11

Interventions

Hypertension OTHER

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

Diabetes type 2 OTHER

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

Obesity OTHER

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

Antihypertensive Agents DRUG

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

Statins (Cardiovascular Agents) DRUG

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

Chronic kidney disease OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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).

You may not qualify if:

• No valid Swedish personal identity number (PIN)

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Södersjukhuset

Stockholm, 11883, Sweden

Location

Related Publications (1)

• 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.

  PMID: 33597145 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Adiposity; Antihypertensive Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Cardiovascular Agents

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Lipid Regulating Agents

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: March 1, 2020
• Primary Completion: June 8, 2021
• Study Completion: December 31, 2023
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

SE (1)