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.
Study Type
OBSERVATIONAL
Enrollment
1,000
SARS-CoV-2 E gene
Vestre Viken Drammen Hospital
Drammen, Akershus, Norway
RECRUITINGHaukeland University Hospital
Bergen, Norway
RECRUITINGØstfold Hospital Trust
Fredrikstad, Norway
Death
Fatal outcome from COVID-19
Time frame: From date of randomization until the date of death from any cause assessed up to 3 months.
Recovery from COVID-19
Resolved infection
Time frame: 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
Time frame: 30 days
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
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
Cell-mediated and humoral immunity
Time frame: From date of randomization until the date of clinical follow-up assessed up to 3 months.
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Akershus University Hospital
Lørenskog, Norway
RECRUITINGOslo University Hospital
Oslo, Norway
RECRUITINGUniversity Hospital North Norway
Tromsø, Norway
RECRUITINGSt Olavs Hospital
Trondheim, Norway
RECRUITING