NCT04314232

Brief Summary

Covid-19 is associated with a wide range of symptoms and clinical trajectories, and early identification of patients at risk for developing severe disease is desirable. Several risk markers and comorbidity profiles have been proposed but their relative importance in unselected patients admitted to hospital with Covid-19 remains unclear. This study aims to assess the prognostic value organ specific biomarkers, viral dynamics and immune response markers in patients infected with SARS-CoV2.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 17, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

March 18, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 26, 2020

Status Verified

June 1, 2020

Enrollment Period

1.8 years

First QC Date

March 17, 2020

Last Update Submit

June 24, 2020

Conditions

COVIDCoronavirus Infection

Keywords

Covid-19BiomarkersCardiovascular diseasePrognosis

Outcome Measures

Primary Outcomes (1)

  • Number of participants with ICU admission or death

    Combined outcome measure of either ICU admission or death

    From hospital admission (baseline) until the date of either admission to the ICU or death during the index hospitalization (up to 52 weeks)

Secondary Outcomes (4)

  • Number of participants with ICU admission

    From hospital admission (baseline) until the date of admission to the ICU during the index hospitalization (up to 52 weeks)

  • Number of participants with death from all causes

    From hospital admission (baseline) unitl the date of death during the index hospitalization (up to 52 weeks)

  • Total duration of ICU stay

    From admission to the ICU until transfer to another ward, discharge from the hospital or death during the index hospitalization (up to 52 weeks)

  • Total duration of hospital stay

    From hospital admission (baseline) until hospital discharge or death during the index hospitalization (up to 52 weeks)

Eligibility Criteria

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

All patients with a positive test for SARS-CoV2 admitted to Akershus University Hospital.

You may qualify if:

  • Healty age-matched volunteers will be included as a control group

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus University Hospital

Lørenskog, Norway

RECRUITING

Related Publications (4)

  • Omland T, Prebensen C, Jonassen C, Svensson M, Berdal JE, Seljeflot I, Myhre PL. Soluble ST2 concentrations associate with in-hospital mortality and need for mechanical ventilation in unselected patients with COVID-19. Open Heart. 2021 Dec;8(2):e001884. doi: 10.1136/openhrt-2021-001884.

    PMID: 34933965DERIVED

  • Myhre PL, Heck SL, Skranes JB, Prebensen C, Jonassen CM, Berge T, Mecinaj A, Melles W, Einvik G, Ingul CB, Tveit A, Berdal JE, Rosjo H, Lyngbakken MN, Omland T. Cardiac pathology 6 months after hospitalization for COVID-19 and association with the acute disease severity. Am Heart J. 2021 Dec;242:61-70. doi: 10.1016/j.ahj.2021.08.001. Epub 2021 Aug 13.

    PMID: 34400140DERIVED

  • Myhre PL, Prebensen C, Jonassen CM, Berdal JE, Omland T. SARS-CoV-2 Viremia is Associated With Inflammatory, But Not Cardiovascular Biomarkers, in Patients Hospitalized for COVID-19. J Am Heart Assoc. 2021 May 4;10(9):e019756. doi: 10.1161/JAHA.120.019756. Epub 2021 Feb 18.

    PMID: 33596668DERIVED

  • Myhre PL, Prebensen C, Strand H, Roysland R, Jonassen CM, Rangberg A, Sorensen V, Sovik S, Rosjo H, Svensson M, Berdal JE, Omland T. Growth Differentiation Factor 15 Provides Prognostic Information Superior to Established Cardiovascular and Inflammatory Biomarkers in Unselected Patients Hospitalized With COVID-19. Circulation. 2020 Dec;142(22):2128-2137. doi: 10.1161/CIRCULATIONAHA.120.050360. Epub 2020 Oct 15.

    PMID: 33058695DERIVED

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Torbjørn Omland, MD, PhD

CONTACT

67960000torbjorn.omland@medisin.uio.no

Study Design

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

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 19, 2020

Study Start

March 18, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 26, 2020

Record last verified: 2020-06

Locations

NO(1)