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Completed

NCT Number: NCT04390074

COVID-19 in the Swedish ICU-cohort: Risk Factors of Critical Care Admission and Intensive Care Mortality

The Corona virus disease 2019 (COVID-19) pandemic is currently involving all parts of the world. Several risk factors for critical illness and death from the disease have been proposed. However, the observed associations between different comorbidities and chronic medications have not fully been related to the frequencies of the same comorbidities and chronic medications in age- and sex-matched controls from the general population. This is important since some of the proposed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of the disease.

By combining several registries, we will compare, on several comorbidities such as hypertension and diabetes and several medications such as immunosuppressant drugs and Angiotensin Converting Enzyme (ACE)-inhibitors, the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a set 8000 age- and sex-matched controls.

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Key information

About this study

The COVID-19 pandemic is currently involving all parts of the world. Several risk factors for critical illness and death from the disease have been proposed. However, the observed associations between different comorbidities and chronic medications have not fully been related to the frequencies of the same comorbidities and chronic medications in age- and sex-matched controls from the general population. This is important since some of the proposed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of the disease.

By combining several registries, we will compare, on several comorbidities such as hypertension and diabetes and several medications such as immunosuppressant drugs and ACE-inhibitors, the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a set 8000 age- and sex-matched controls.

Data sources:

Registries of the Swedish board of Health and wellfare:

  • The patient registry containing information including diagnostic codes from all specialized Healthcare contacts in Sweden. Reporting i governed by law.
  • The Swedish Prescribed Drug Register to which all dispensations from pharmacies of prescribed drugs are reported.

Statistics Sweden is the agency responsible for the official population statistics of Sweden. They will draw our controls from the Registry of the total population.

The Swedish Intensive Care Registry (SIR) contains all intensive care episodes in Sweden. They have information on Intensive Care (ICU) admission, diagnoses, interventions and outcomes.

The study design is combined prospective ond retrospective. The data is prospectively collected to the registries but the study protocol is retrospectively designed.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Included in the SIR with COVID-19 any time until data acquisition

Exclusion criteria

-Age below 18 years.

Treatment and study plan

COVID-19 and Intensive Care

Other

No intervention, observational.

Primary outcomes

  1. Chronic medications as risk factor of intensive care for COVID-19

    Time frame: Drug dispensation within 6 months prior inclusion

    Odds ratio of intensive care treated patients with COVID-19 having ongoing treatment with drugs blocking the Renin-Angiotensin-Aldosterone-System (RAAS), statins, immunosuppressant drugs, oral anticoagulant drugs, oral thrombocyte aggregation inhibitors or antiviral drugs.

  2. Comorbidities as risk factor of intensive care for COVID-19

    Time frame: 5 years prior to inclusion

    Odds ratio of intensive care treated patients with COVID-19 having been diagnosed with diabetes typ I, diabetes type II, ischemic heart disease, other heart disease, cerebrovascular disease, cancer, chronic renal failure, chronic obstructive pulmonary disease (COPD) asthma, obesity, immunosuppressed disease or systemic inflammatory disease.

Secondary outcomes

  1. Chronic medications as risk factor of death during intensive care for COVID-19

    Time frame: Drug dispensation within 6 months prior inclusion

    Odds ratio of patients who have died during intensive care with COVID-19 having ongoing treatment with drugs blocking the Renin-Angiotensin-Aldosterone-System (RAAS), statins, immunosuppressant drugs, oral anticoagulant drugs, oral thrombocyte aggregation inhibitors or antiviral drugs.

  2. Comorbidities as risk factor of death during intensive care for COVID-19

    Time frame: 5 years prior to inclusion

    Odds ratio of patients who have died during intensive care with COVID-19 having been diagnosed with diabetes typ I, diabetes type II, ischemic heart disease, other heart disease, cerebrovascular disease, cancer, chronic renal failure, chronic obstructive pulmonary disease (COPD) asthma, obesity, immunosuppressed disease or systemic inflammatory disease.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Center for Clinical Research Dalarna, Sweden

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 15, 2020
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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