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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04390074
• Other study ID #: UTN: U1111-1251-8195
• Status: Completed
• Start date: May 27, 2020
• Est. completion date: June 4, 2020

Study information

• Verified date: August 2020
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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:

1. The patient registry containing information including diagnostic codes from all specialized Healthcare contacts in Sweden. Reporting i governed by law.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9905
• Est. completion date: June 4, 2020
• Est. primary completion date: June 4, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-Age below 18 years.

Related Conditions & MeSH terms

• COVID-19
• Critical Illness

Intervention

Other:
• COVID-19 and Intensive Care
No intervention, observational.

Locations

Country	Name	City	State
Sweden	Björn Ahlström	Falun

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Center for Clinical Research Dalarna, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic medications as risk factor of intensive care for COVID-19	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.	Drug dispensation within 6 months prior inclusion
Primary	Comorbidities as risk factor of intensive care for COVID-19	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.	5 years prior to inclusion
Secondary	Chronic medications as risk factor of death during intensive care for COVID-19	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.	Drug dispensation within 6 months prior inclusion
Secondary	Comorbidities as risk factor of death during intensive care for COVID-19	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.	5 years prior to inclusion