NCT04462393

Brief Summary

This is a registry-based cohort study of all adult patients (≥18 years) admitted to Swedish Intensive Care Units with confirmed SARS-CoV-2 infection and COVID-19 disease during the first 2 months of the 2020 pandemic. The main goal is to describe demographic characteristics, coexisting conditions, treatments and outcomes among critically ill patients with COVID-19. A secondary goal is to identify independent risk factors associated with increased mortality for these patients. Data regarding baseline characteristics including comorbidities, intensive care treatments and outcomes will be extracted. ICU lengths of stay and 30-day mortalities will be calculated. The primary outcome is 30-day all-cause mortality. THIS PART OF THE STUDY HAS BEEN COMPLETED. UPDATE 26 Feb 2022: Characteristics and outcomes of 'first wave' patients admitted to Swedish ICUs was published in Eur J Anaesthesiol. 2021 Apr 1;38(4):335-343. doi: 10.1097/EJA.0000000000001459. A description of the surge response and aggregated data outcomes in Scandinavian countries was published in https://onlinelibrary.wiley.com/doi/10.1111/aas.13983. UPDATE 13 Nov 2024: ADDITIONAL SUMMARY - EXTENDED INCLUSION PERIOD AND ADDITION OF LONG-TERM OUTCOMES, AND CRITICALLY ILL PATIENTS WITH INFLUENZA AND VIRAL PNEUMONITIS Due to the continued influx of patients requiring intensive care due to COVID-19, we extended the inclusion period to 31 Dec 2022. Thus this new cohort will include all patients admitted to ICUs in Sweden from 6 March 2020 to 31 Dec 2022. We will investigate short (30day mortality) and long-term outcomes (365d mortality and cardiovascular complications) of patients admitted to Swedish ICUs with confirmed SARS-CoV-2 infection and COVID-19 disease. In international research, the long-term effects of ICU-requiring COVID-19 are now highly topical. Long-term follow-up exceeding one year has not yet been conducted on any Swedish material. To concretely understand the actual implications of long-term outcomes, it is becoming almost standard to compare this patient group to ICU-requiring influenza + viral pneumonitis patients to some extent. We have applied for and obtained ethical approval to include this group as a potential comparator to COVID-19 patients. However, such comparisons require careful consideration of potential confounders, such as patient characteristics and socioeconomic factors. It is therefore crucial to both establish the disease burden for the population and relate it to a comparable patient group. Ethical approval and national data linkage approvals have now been obtained to extract this data from Statistics Sweden and the Swedish National Board of Health and Welfare registries. Data linkage was completed in October 2024.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,500

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Mar 2020Dec 2026

Study Start

First participant enrolled

March 6, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

4.7 years

First QC Date

July 6, 2020

Last Update Submit

March 15, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 30-day mortality

    all-cause

    30 days

  • 365-day mortality

    all-cause

    365 days (additional outcome added Oct 2021 after additional approval from ethical committee)

Secondary Outcomes (2)

  • ICU mortality

    30 days

  • Morbidity

    up to 365 days after study inclusion

Other Outcomes (1)

  • Mortality at longest follow-up

    6 Mar 2020 to 31 Dec 2022

Interventions

All patients admitted to Swedish ICUs with COVID-19 between 6 Mar - 6 May 2020

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients (≥18 years) admitted to Swedish Intensive Care Units with confirmed SARS-CoV-2 infection and COVID-19 disease during the first 2 months of the 2020 pandemic (6 March-6May2020).

You may qualify if:

  • Adult patients (≥18 years)
  • COVID-19 disease

You may not qualify if:

  • No Swedish personal identity number
  • 'Opt out' from Swedish Intensive Care Registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesia and Intensive Care, Linkoeping University Hospital, Region Östergötland

Linköping, Östergötland County, 50185, Sweden

Location

Related Publications (1)

  • Chew MS, Blixt PJ, Ahman R, Engerstrom L, Andersson H, Berggren RK, Tegnell A, McIntyre S. National outcomes and characteristics of patients admitted to Swedish intensive care units for COVID-19: A registry-based cohort study. Eur J Anaesthesiol. 2021 Apr 1;38(4):335-343. doi: 10.1097/EJA.0000000000001459.

MeSH Terms

Conditions

COVID-19Critical Illness

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 8, 2020

Study Start

March 6, 2020

Primary Completion

October 31, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations