Prospective Observational Cohort Study of Critically Ill Patients With Covid-19 in Sweden

March 11, 2021 updated by: Erland Ostberg, Region Västmanland

Characteristics and Outcomes of Critically Ill Patients With Covid-19 in a Large Swedish County Hospital - a Prospective Observational Cohort Study

The study will prospectively collect data from patients with Covid-19 admitted to the Västerås Intensive Care Unit, Västerås Hospital. Demographic, clinical, radiographic and laboratory characteristics will be recorded. Analysis of data to identify predictors of disease severity, mortality and treatment response.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västmanland
      • Västerås, Västmanland, Sweden, 723 48
        • Intensive Care Unit, Västerås Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Covid-19.

Description

Inclusion Criteria:

  • Patients admitted to the Intensive Care Unit with biological samples positive for SARS-CoV-2.
  • Patients admitted to the Intensive Care Unit with one or more negative tests but with clinical and radiological characteristics highly suggestive of SARS-CoV-2 and thus considered positive for the disease.

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Covid-19
Patients with verified or highly suggestive Covid-19 diagnosis and Intensive Care treatment.
Other: Observational study
Not required

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: At 90 days follow-up after admittance to Intensive Care
At 90 days follow-up after admittance to Intensive Care

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital length of stay
Time Frame: Until 90 days after admittance to Intensive Care
Until 90 days after admittance to Intensive Care
ICU length of stay
Time Frame: Until 90 days after admittance to Intensive Care
Until 90 days after admittance to Intensive Care
Number of days on mechanical ventilation
Time Frame: Until 90 days after admittance to Intensive Care
Until 90 days after admittance to Intensive Care
Number of patients receiving vasopressor support
Time Frame: Until 90 days after admittance to Intensive Care
Until 90 days after admittance to Intensive Care
Number of patients receiving renal replacement therapy
Time Frame: Until 90 days after admittance to Intensive Care
Until 90 days after admittance to Intensive Care
Patient characteristics
Time Frame: At admission to ICU
At admission to ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Västmanland

Investigators

  • Principal Investigator: Erland Östberg, M.D., Ph.D., Region Västmanland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2020

Primary Completion (Actual)

November 12, 2020

Study Completion (Actual)

November 12, 2020

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RegionVastmanland

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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