SARS VirusNCT04381819
Norwegian SARS-CoV-2 Study - Virological, Clinical and Immunological Characterisation of COVID-19
An observational study of SARS Virus and Severe Acute Respiratory Syndrome, run by Oslo University Hospital at 7 sites in Norway.
Trial summary
Oslo University Hospital has initiated an observational study on hospitalised patients with confirmed COVID-19, the infection caused by Severe Acute Respiratory Syndrome Coronavirus type 2 (SARS-CoV-2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS Virus, Severe Acute Respiratory Syndrome
- What is being tested?
- SARS-CoV-2 PCR
- How many people
- 1,000 participants
- Where
- 7 sitesNorway
- Study dates
- 2 Mar 2020to 31 Dec 2023
- 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 admitted to Oslo University Hospital, Vestre Viken Drammen Hospital, Akershus University Hospital or Østfold Hospital Kalnes will be recruited consecutively after testing positive for SARS-CoV-2
Who may be able to join
- Confirmed COVID-19 by screening of SARS-CoV-2 E-gene
Who cannot join
- Refusal of consent by patient or closest relative
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Norway7 sites, 7 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5021
Bjørn Blomberg, PhD
- Recruiting
Vestre Viken Drammen Hospital
Drammen, Akershus, 3000
Lars Heggelund, PhD
Lars.Heggelund@vestreviken.no
- Recruiting
Østfold Hospital Trust
Fredrikstad, 1714
Jonas Bergan, phd
- Recruiting
Akershus University Hospital
Lørenskog, 1478
Christian Prebensen, PhD
- Recruiting
Oslo University Hospital
Oslo, 0424
Jan C Holter, PhD, +4791195761 ext. +4791195761, jacaho@ous-hf.no
Susanne G Dudman, Ass.Professor, +4791195761 ext. +4791195761, Susanne.Dudman@ous-hf.no
- Recruiting
University Hospital North Norway
Tromsø, 9019
Anders B Kildal, PhD
- Recruiting
St Olavs Hospital
Trondheim, 7030
Erik Solligård, PhD
About this study
Official title: Norwegian SARS-CoV-2 Study - Virological, Clinical and Immunological Characterisation of Inpatients During the COVID-19 Outbreak: A Prospective Cohort Study
Oslo University Hospital has initiated an observational study on hospitalised patients with confirmed COVID-19, the infection caused by Severe Acute Respiratory Syndrome Coronavirus type 2 (SARS-CoV-2).
Read the detailed description
Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS-CoV-2, require investigation to understand pathogen biology and pathogenesis in the host. In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host directed therapies, the transmission dynamics, and factors underlying individual susceptibility.
At Oslo University Hospital, an observational study on the newly discovered emerging SARS- CoV-2, the coronavirus that causes COVID-19 infection has started. The study has been approved by the Regional Ethics Committee, so that inclusion of confirmed COVID-19 cases admitted at the hospital can start immediately including the first patients needing hospitalisation. The plan is to include more hospitals in other parts of Norway, starting with inclusion of Akershus University Hospital, Vestre Viken Drammen Hospital and Østfold Hospital. The study is anticipated to provide much needed data on the course of the COVID-19 infection, as well as generating knowledge about the virus and its transmission.
- Conditions
- SARS Virus, Severe Acute Respiratory Syndrome
- Being tested
- SARS-CoV-2 PCR
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 PCRDiagnostic test
SARS-CoV-2 E gene
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Fatal outcome from COVID-19
Measured: From date of randomization until the date of death from any cause assessed up to 3 months.
Recovery from COVID-19
Resolved infection
Measured: From date of randomization until the date of recovery from COVID-19 symptoms assessed up to 3 months.
Progression to ICU care or ventilation
Percentage of patients requiring intensive care admission or ventilation
Measured: 30 days
Secondary outcomes (2)
Clearance of SARS-CoV-2 from respiratory specimen
The change in(clearance of) viral RNA measured by polymerase chain reaction assay (PCR) test at days 1, 3, 8,14 and 90 days
Measured: The number of calendar days from date of PCR positive test (counted as 1 day) in respiratory specimen until date of such test first become negative in the respiratory specimen assessed up to 3 months
Immune response to COVID-19
Cell-mediated and humoral immunity
Measured: From date of randomization until the date of clinical follow-up assessed up to 3 months.
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 start2 Mar 2020
- Primary completion28 Feb 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS VirusStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus, Vestre Viken Hospital Trust, Ostfold Hospital Trust, Haukeland University Hospital, University Hospital of North Norway, St. Olavs Hospital
- Responsible party
- Principal investigator, Jan Cato Holter, Oslo University Hospital
- Investigators
- Fredrik G Müller, Professor, Study director, University of OsloSusanne G Dudman, Professor, Study chair, University of OsloJan C Holter, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381819
- Sponsor's protocol ID
- 20-04072
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 11 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Troseid M, Holter JC, Holm K, Vestad B, Sazonova T, Granerud BK, Dyrhol-Riise AM, Holten AR, Tonby K, Kildal AB, Heggelund L, Tveita A, Boe S, Muller KE, Jenum S, Hov JR, Ueland T; Norwegian SARS-CoV-2 study group. Gut microbiota composition during hospitalization is associated with 60-day mortality after severe COVID-19. Crit Care. 2023 Feb 23;27(1):69. doi: 10.1186/s13054-023-04356-2.
PubMed 36814280Tveita A, Murphy SL, Holter JC, Kildal AB, Michelsen AE, Lerum TV, Kaarbo M, Heggelund L, Holten AR, Finbraten AK, Muller KE, Mathiessen A, Boe S, Fevang B, Granerud BK, Tonby K, Lind A, Dudman SG, Henriksen KN, Muller F, Skjonsberg OH, Troseid M, Barratt-Due A, Dyrhol-Riise AM, Aukrust P, Halvorsen B, Dahl TB, Ueland T; NOR-SOLIDARITY Consortium and the Norwegian SARS-CoV-2 Study Group Investigators. High Circulating Levels of the Homeostatic Chemokines CCL19 and CCL21 Predict Mortality and Disease Severity in COVID-19. J Infect Dis. 2022 Dec 13;226(12):2150-2160. doi: 10.1093/infdis/jiac313.
PubMed 35876699
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norwegian SARS-CoV-2 Study - Virological, Clinical and Immunological Characterisation of Inpatients During the COVID-19 Outbreak: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04381819
- Acronym / sponsor ID
- 20-04072
- Conditions
- SARS Virus, Severe Acute Respiratory Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Akershus, Vestre Viken Hospital Trust, Ostfold Hospital Trust, Haukeland University Hospital, University Hospital of North Norway, St. Olavs Hospital
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- 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.
Oslo University Hospital has initiated an observational study on hospitalised patients with confirmed COVID-19, the infection caused by Severe Acute Respiratory Syndrome Coronavirus type 2 (SARS-CoV-2).
Detailed description
Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS-CoV-2, require investigation to understand pathogen biology and pathogenesis in the host. In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host directed therapies, the transmission dynamics, and factors underlying individual susceptibility.
At Oslo University Hospital, an observational study on the newly discovered emerging SARS- CoV-2, the coronavirus that causes COVID-19 infection has started. The study has been approved by the Regional Ethics Committee, so that inclusion of confirmed COVID-19 cases admitted at the hospital can start immediately including the first patients needing hospitalisation. The plan is to include more hospitals in other parts of Norway, starting with inclusion of Akershus University Hospital, Vestre Viken Drammen Hospital and Østfold Hospital. The study is anticipated to provide much needed data on the course of the COVID-19 infection, as well as generating knowledge about the virus and its transmission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Oslo University Hospital, Vestre Viken Drammen Hospital, Akershus University Hospital or Østfold Hospital Kalnes will be recruited consecutively after testing positive for SARS-CoV-2
Key inclusion criteria (1 listed)
- Confirmed COVID-19 by screening of SARS-CoV-2 E-gene
Key exclusion criteria (1 listed)
- Refusal of consent by patient or closest relative
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 |
|---|---|---|
| SARS-CoV-2 PCRSARS-CoV-2 E gene | Diagnostic test | – |
Primary outcome
Death
Time frame: From date of randomization until the date of death from any cause assessed up to 3 months.
Fatal outcome from COVID-19
Recovery from COVID-19
Time frame: From date of randomization until the date of recovery from COVID-19 symptoms assessed up to 3 months.
Resolved infection
Progression to ICU care or ventilation
Time frame: 30 days
Percentage of patients requiring intensive care admission or ventilation
2 secondary outcomes
Clearance of SARS-CoV-2 from respiratory specimen
Time frame: The number of calendar days from date of PCR positive test (counted as 1 day) in respiratory specimen until date of such test first become negative in the respiratory specimen assessed up to 3 months
Immune response to COVID-19
Time frame: From date of randomization until the date of clinical follow-up assessed up to 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Derived from this study: PubMed 36814280Troseid M, Holter JC, Holm K, Vestad B, Sazonova T, Granerud BK, Dyrhol-Riise AM, Holten AR, Tonby K, Kildal AB, Heggelund L, Tveita A, Boe S, Muller KE, Jenum S, Hov JR, Ueland T; Norwegian SARS-CoV-2 study group. Gut microbiota composition during hospitalization is associated with 60-day mortality after severe COVID-19. Crit Care. 2023 Feb 23;27(1):69. doi: 10.1186/s13054-023-04356-2.
- Derived from this study: PubMed 35876699Tveita A, Murphy SL, Holter JC, Kildal AB, Michelsen AE, Lerum TV, Kaarbo M, Heggelund L, Holten AR, Finbraten AK, Muller KE, Mathiessen A, Boe S, Fevang B, Granerud BK, Tonby K, Lind A, Dudman SG, Henriksen KN, Muller F, Skjonsberg OH, Troseid M, Barratt-Due A, Dyrhol-Riise AM, Aukrust P, Halvorsen B, Dahl TB, Ueland T; NOR-SOLIDARITY Consortium and the Norwegian SARS-CoV-2 Study Group Investigators. High Circulating Levels of the Homeostatic Chemokines CCL19 and CCL21 Predict Mortality and Disease Severity in COVID-19. J Infect Dis. 2022 Dec 13;226(12):2150-2160. doi: 10.1093/infdis/jiac313.
- 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.
Fredrik G Müller, Professor study director
University of Oslo
Susanne G Dudman, Professor study chair
University of Oslo
Jan C Holter, PhD principal investigator
Oslo University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS Virus and Severe Acute Respiratory Syndrome, run by Oslo University Hospital at 7 sites 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 1 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 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Jan C Holter, PhD (+4791195761 ext. +4723071155, jacaho@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: From date of randomization until the date of death from any cause assessed up to 3 months.). The study lists 3 primary outcomes in all. 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 NCT04381819, which also lists 2 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 11 May 2020.