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

NCT04390074 | Completed

• 1 other identifier: UTN: U1111-1251-8195
• Study Type: observational
• Target: 9,905
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19; Critical Illness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  Drug dispensation within 6 months prior inclusion

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

  5 years prior to inclusion

Study Arms (2)

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

Control

Age- and sex-matched controls are drawn from all residents of Sweden by Statistics Sweden.

Interventions

COVID-19 and Intensive Care OTHER

No intervention, observational.

COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Age below 18 years.

Sponsors & Collaborators

• Uppsala University: lead
• Center for Clinical Research Dalarna, Sweden: collaborator

Study Sites (1)

Björn Ahlström

Falun, 79182, Sweden

Location

MeSH Terms

Conditions

COVID-19; Critical Illness

Interventions

Critical Care

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Miklos Lipcsey, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 15, 2020
• Study Start: May 27, 2020
• Primary Completion: June 4, 2020
• Study Completion: June 4, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)