NCT04382417

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 26, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2020

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

May 4, 2020

Last Update Submit

March 11, 2021

Conditions

Covid-19Critical Illness

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    At 90 days follow-up after admittance to Intensive Care

Secondary Outcomes (6)

  • Hospital length of stay

    Until 90 days after admittance to Intensive Care

  • ICU length of stay

    Until 90 days after admittance to Intensive Care

  • Number of days on mechanical ventilation

    Until 90 days after admittance to Intensive Care

  • Number of patients receiving vasopressor support

    Until 90 days after admittance to Intensive Care

  • Number of patients receiving renal replacement therapy

    Until 90 days after admittance to Intensive Care

  • +1 more secondary outcomes

Study Arms (1)

Covid-19

Patients with verified or highly suggestive Covid-19 diagnosis and Intensive Care treatment.

Other: Observational study

Interventions

Observational studyOTHER

Not required

Covid-19

Eligibility Criteria

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

Patients with Covid-19.

You may qualify if:

  • 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.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit, Västerås Hospital

Västerås, Västmanland County, 723 48, Sweden

Location

MeSH Terms

Conditions

COVID-19Critical Illness

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Erland Östberg, M.D., Ph.D.

    Region Västmanland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 11, 2020

Study Start

March 26, 2020

Primary Completion

November 12, 2020

Study Completion

November 12, 2020

Last Updated

March 15, 2021

Record last verified: 2021-03

Locations

SE(1)