Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital, Akershus | OTHER |
| Vestre Viken Hospital Trust | OTHER |
| Ostfold Hospital Trust | OTHER |
| Haukeland University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 PCR | Diagnostic Test | SARS-CoV-2 E gene |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Fatal outcome from COVID-19 | From date of randomization until the date of death from any cause assessed up to 3 months. |
| Recovery from COVID-19 | Resolved infection | 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan C Holter, PhD | Contact | +4791195761 | +4723071155 | jacaho@ous-hf.no |
| Susanne G Dudman, PhD | Contact | +4723071155 | +4723071155 | Susanne.Dudman@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Fredrik G Müller, Professor | University of Oslo | Study Director |
| Susanne G Dudman, Professor | University of Oslo | Study Chair |
| Jan C Holter, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vestre Viken Drammen Hospital | Recruiting | Drammen | Akershus | 3000 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36814280 | Derived | 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. | |
| 35876699 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000087123 | COVID-19 Nucleic Acid Testing |
| ID | Term |
|---|---|
| D000086742 | COVID-19 Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
| OTHER |
| University Hospital of North Norway | OTHER |
| St. Olavs Hospital | OTHER |
Not provided
Not provided
Not provided
Respiratory secretions, blood, urine, stool, cerebrospinal fluid
| Immune response to COVID-19 | Cell-mediated and humoral immunity | From date of randomization until the date of clinical follow-up assessed up to 3 months. |
| Oslo University Hospital |
| Principal Investigator |
| Haukeland University Hospital | Recruiting | Bergen | 5021 | Norway |
|
| Østfold Hospital Trust | Recruiting | Fredrikstad | 1714 | Norway |
|
| Akershus University Hospital | Recruiting | Lørenskog | 1478 | Norway |
|
| Oslo University Hospital | Recruiting | Oslo | 0424 | Norway |
|
| University Hospital North Norway | Recruiting | Tromsø | 9019 | Norway |
|
| St Olavs Hospital | Recruiting | Trondheim | 7030 | Norway |
|
| Derived |
| Tveita 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. |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D008919 | Investigative Techniques |