Clinical trial NCT04314232: Mechanisms for Covid-19 Disease Complications
Official title: Changes in Organ Specific Biomarkers, Virus Expression and Prognosis of Covid-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Coronavirus Infection
Keywords: Covid-19
Biomarkers
Cardiovascular disease
Prognosis
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a positive test for SARS-CoV2 admitted to Akershus University Hospital.

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.


Eligibility criteria: Inclusion Criteria:

* All patients \>18 years of age with a positive test for SARS-CoV2 are eligble for inclusion.
* Healty age-matched volunteers will be included as a control group

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of participants with ICU admission or death
timeFrame: 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:
measure: Number of participants with ICU admission
timeFrame: From hospital admission (baseline) until the date of admission to the ICU during the index hospitalization (up to 52 weeks)
measure: Number of participants with death from all causes
timeFrame: From hospital admission (baseline) unitl the date of death during the index hospitalization (up to 52 weeks)
measure: Total duration of ICU stay
timeFrame: From admission to the ICU until transfer to another ward, discharge from the hospital or death during the index hospitalization (up to 52 weeks)
measure: Total duration of hospital stay
timeFrame: From hospital admission (baseline) until hospital discharge or death during the index hospitalization (up to 52 weeks)
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.