SARS Virus, Severe Acute Respiratory Syndrome
Conditions
Brief 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).
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.
Interventions
DIAGNOSTIC_TESTSARS-CoV-2 PCR
SARS-CoV-2 E gene
Sponsors
University Hospital, Akershus
Vestre Viken Hospital Trust
Ostfold Hospital Trust
Haukeland University Hospital
University Hospital of North Norway
St. Olavs Hospital
Oslo University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed COVID-19 by screening of SARS-CoV-2 E-gene
Exclusion criteria
* Refusal of consent by patient or closest relative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death | 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 | 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 | 30 days | Percentage of patients requiring intensive care admission or ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clearance of SARS-CoV-2 from respiratory specimen | 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 | The change in(clearance of) viral RNA measured by polymerase chain reaction assay (PCR) test at days 1, 3, 8,14 and 90 days |
| Immune response to COVID-19 | From date of randomization until the date of clinical follow-up assessed up to 3 months. | Cell-mediated and humoral immunity |
Countries
Norway
Contacts
Primary ContactJan C Holter, PhD
Backup ContactSusanne G Dudman, PhD
Outcome results
None listed