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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04382417
Recruitment Status : Completed
First Posted : May 11, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Erland Ostberg, Region Västmanland

Brief Summary:
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.

Condition or disease Intervention/treatment
Covid-19 Critical Illness Other: Observational study

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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characteristics and Outcomes of Critically Ill Patients With Covid-19 in a Large Swedish County Hospital - a Prospective Observational Cohort Study
Actual Study Start Date : March 26, 2020
Actual Primary Completion Date : November 12, 2020
Actual Study Completion Date : November 12, 2020

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




Primary Outcome Measures :
  1. Demographic characteristics of patients with Covid-19 receiving intensive care [ Time Frame: Until 30 days after admittance to Intensive Care ]

Secondary Outcome Measures :
  1. Survival rate in patients with Covid-19 receiving intensive care [ Time Frame: 30 days and 6 months after admission to intensive care ]
  2. Clinical course characteristics of patients with Covid-19 receiving intensive care [ Time Frame: Until 30 days after admittance to Intensive Care ]
  3. Number of days on mechanical ventilation [ Time Frame: Until 30 days after admittance to Intensive Care ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Covid-19.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04382417


Locations
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Sweden
Intensive Care Unit, Västerås Hospital
Västerås, Västmanland, Sweden, 723 48
Sponsors and Collaborators
Region Västmanland
Investigators
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Principal Investigator: Erland Östberg, M.D., Ph.D. Region Västmanland
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Responsible Party: Erland Ostberg, M.D., Ph.D., Region Västmanland
ClinicalTrials.gov Identifier: NCT04382417    
Other Study ID Numbers: RegionVastmanland
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes