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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04426084
Recruitment Status : Active, not recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Per Svensson, 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.

Condition or disease Intervention/treatment
COVID-19 Other: Hypertension Other: Diabetes type 2 Other: Obesity Drug: Antihypertensive Agents Drug: Statins (Cardiovascular Agents)

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, 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 22784 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 3 Years
Official Title: Cardiovascular Disease, Cardiovascular Risk Factors, Treatments and Severe COVID-19 Outcomes. A Nationwide Registry-based Case-Control Study
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : May 11, 2020
Estimated Study Completion Date : December 31, 2022

Intervention Details:
  • Other: 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
  • 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

  • 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
  • Drug: 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

  • Drug: Statins (Cardiovascular Agents)
    Pick up of a prescription of C10AA registered in the Swedish prescribed drug register within 6 month before index date.


Primary Outcome Measures :
  1. Severe Covid-19 [ Time Frame: 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

  2. Severe Covid-19 with pulmonary embolism [ Time Frame: 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 :
  1. CRRT(Continuous Renal Replacement Therapy) [ Time Frame: 2020-03-01 to 2020-05-11 ]
    Number of participants admitted to ICU in Sweden with a verified diagnosis of Covid-19 requring CRRT

  2. ECMO (Extracorporeal Membrane Oxygenation ) [ Time Frame: 2020-03-01 to 2020-05-11 ]
    Number of participants admitted to ICU in Sweden with a verified diagnosis of Covid-19 requring ECMO

  3. ICU Mortality [ Time Frame: 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



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:   Non-Probability Sample
Study Population
A total of 1,424 cases and 14,240 control subjects
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)

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): NCT04426084


Locations
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Sweden
Södersjukhuset
Stockholm, Sweden, 11883
Sponsors and Collaborators
Karolinska Institutet
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Responsible Party: Per Svensson, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04426084    
Other Study ID Numbers: 4
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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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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Antihypertensive Agents