COVIDCOVID MECHNCT04314232
Mechanisms for Covid-19 Disease Complications
An observational study of COVID and Coronavirus Infection, run by University Hospital, Akershus at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID, Coronavirus Infection
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 18 Mar 2020to 31 Dec 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with a positive test for SARS-CoV2 admitted to Akershus University Hospital.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Akershus University Hospital
Lørenskog
Peder Myhre, MD, PhD, 6790000, p.l.myhre@medisin.uio.no
About this study
Official title: Changes in Organ Specific Biomarkers, Virus Expression and Prognosis of Covid-19
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.
- Conditions
- COVID, Coronavirus Infection
- Keywords
- Covid-19, Biomarkers, Cardiovascular disease, Prognosis
- Medical subject headings
- Coronavirus Infections, COVID-19, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with ICU admission or death
Combined outcome measure of either ICU admission or death
Measured: 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
ICU admission
Measured: 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
Hospital mortality
Measured: From hospital admission (baseline) unitl the date of death during the index hospitalization (up to 52 weeks)
Total duration of ICU stay
Total time admitted to the ICU
Measured: 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
Measured: From hospital admission (baseline) until hospital discharge or death during the index hospitalization (up to 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start18 Mar 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Torbjorn Omland, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314232
- Sponsor's protocol ID
- 117589
- Acronym
- COVID MECH
- Status last verified
- Jun 2020
- First submitted
- 17 Mar 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34933965Myhre 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.
PubMed 34400140Myhre 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.
PubMed 33596668Myhre 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.
PubMed 33058695
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Organ Specific Biomarkers, Virus Expression and Prognosis of Covid-19
- ClinicalTrials.gov ID
- NCT04314232
- Acronym / sponsor ID
- COVID MECH / 117589
- Conditions
- COVID, Coronavirus Infection
- Keywords
- Covid-19, Biomarkers, Cardiovascular disease, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Mar 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a positive test for SARS-CoV2 admitted to Akershus University Hospital.
Key inclusion criteria (2 listed)
- 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
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.
Primary outcome
Number of participants with ICU admission or death
Time frame: From hospital admission (baseline) until the date of either admission to the ICU or death during the index hospitalization (up to 52 weeks)
Combined outcome measure of either ICU admission or death
4 secondary outcomes
Number of participants with ICU admission
Time frame: 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
Time frame: From hospital admission (baseline) unitl the date of death during the index hospitalization (up to 52 weeks)
Total duration of ICU stay
Time frame: 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
Time frame: From hospital admission (baseline) until hospital discharge or death during the index hospitalization (up to 52 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Derived from this study: PubMed 34933965Omland 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.
- Derived from this study: PubMed 34400140Myhre 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.
- Derived from this study: PubMed 33596668Myhre 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.
- Derived from this study: PubMed 33058695Myhre 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.
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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.
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 and Coronavirus Infection, run by University Hospital, Akershus at 1 site in Norway.
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: status not confirmed, as of the sponsor's last update on 26 Jun 2020. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Torbjørn Omland, MD, PhD (67960000, torbjorn.omland@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with ICU admission or death (time frame: From hospital admission (baseline) until the date of either admission to the ICU or death during the index hospitalization (up to 52 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04314232, which also lists 4 linked publications.
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 26 Jun 2020; AzTrials last refreshed its copy on 5 Nov 2026.