Covid-19NCT04382417
Prospective Observational Cohort Study of Critically Ill Patients With Covid-19 in Sweden
An observational study of Covid-19 and Critical Illness, run by Region Västmanland at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19, Critical Illness
- What is being tested?
- Observational study
- How many people
- 57 participants
- Where
- 1 siteSweden
- Study dates
- 26 Mar 2020to 12 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Covid-19.
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Intensive Care Unit, Västerås Hospital
Västerås, Västmanland County, 723 48
About this study
Official title: 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.
- Conditions
- Covid-19, Critical Illness
- Being tested
- Observational study
- Medical subject headings
- COVID-19, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Not required
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 | Patients with verified or highly suggestive Covid-19 diagnosis and Intensive Care treatment. Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: At 90 days follow-up after admittance to Intensive Care
Secondary outcomes (6)
Hospital length of stay
Measured: Until 90 days after admittance to Intensive Care
ICU length of stay
Measured: Until 90 days after admittance to Intensive Care
Number of days on mechanical ventilation
Measured: Until 90 days after admittance to Intensive Care
Number of patients receiving vasopressor support
Measured: Until 90 days after admittance to Intensive Care
Number of patients receiving renal replacement therapy
Measured: Until 90 days after admittance to Intensive Care
Patient characteristics
Measured: At admission to ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start26 Mar 2020
- Primary completion12 Nov 2020
- Study completion12 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Västmanland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erland Ostberg, Region Västmanland
- Investigators
- Erland Östberg, M.D., Ph.D., Principal investigator, Region Västmanland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382417
- Sponsor's protocol ID
- RegionVastmanland
- Status last verified
- Mar 2021
- First submitted
- 4 May 2020
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Outcomes of Critically Ill Patients With Covid-19 in a Large Swedish County Hospital - a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04382417
- Acronym / sponsor ID
- RegionVastmanland
- Conditions
- Covid-19, Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Region VästmanlandUniversity, hospital or other
- Study start
- 26 Mar 2020 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid-19 | – | Other: Observational studyPatients with verified or highly suggestive Covid-19 diagnosis and Intensive Care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Covid-19.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyNot required | Other | Covid-19 |
Primary outcome
All-cause mortality
Time frame: At 90 days follow-up after admittance to Intensive Care
6 secondary outcomes
Hospital length of stay
Time frame: Until 90 days after admittance to Intensive Care
ICU length of stay
Time frame: Until 90 days after admittance to Intensive Care
Number of days on mechanical ventilation
Time frame: Until 90 days after admittance to Intensive Care
Number of patients receiving vasopressor support
Time frame: 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
Patient characteristics
Time frame: At admission to ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erland Östberg, M.D., Ph.D. principal investigator
Region Västmanland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 and Critical Illness, run by Region Västmanland at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: At 90 days follow-up after admittance to Intensive Care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.