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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Critical Illness
• Intervention / Treatment: Other: COVID-19 and Intensive Care

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 9905

Contacts and Locations

Study Locations

• Sweden
  • Falun, Sweden, 79182
    • Björn Ahlström

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The SIR is a registry to which all Swedish intensive care units are reporting all intensive care patients. The SIR has a specific part to wich all CIVID-19 related intensive care eposodes are reported. We will include, as cases, all patients, approximally 2000, who have at least one COVID-19 listing in the registry. Statistics Sweden will draw a random sample of age and sex matched controls, 4 per case, from all residents of Sweden, approximately 10 million.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-Age below 18 years.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19; Patients with COVID-19 who have received or are receiving Intensive Care in Sweden. Patients are identified in the Swedish Intensive care registry, to which all Swedish intensive care units (ICU) are reporting all intensive care patients.	Other: COVID-19 and Intensive Care; No intervention, observational.
Control; Age- and sex-matched controls are drawn from all residents of Sweden by Statistics Sweden.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Center for Clinical Research Dalarna, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2020
• Primary Completion (Actual): June 4, 2020
• Study Completion (Actual): June 4, 2020

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 21, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Critical Illness
• Other Study ID Numbers: UTN: U1111-1251-8195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Sharing of IPD is not allowed under the permission of the ethical review board.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No