NCT04381819

Norwegian SARS-CoV-2 Study - Virological, Clinical and Immunological Characterisation of COVID-19

Norwegian SARS-CoV-2 Study - Virological, Clinical and Immunological Characterisation of Inpatients During the COVID-19 Outbreak: A Prospective Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• SARS Virus
• Severe Acute Respiratory Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	SARS-CoV-2 PCR	SARS-CoV-2 E gene

Timeline

• Start date: 2020-03-02
• Primary completion: 2022-02-28
• Completion: 2023-12-31
• First posted: 2020-05-11
• Last updated: 2020-05-11

Locations

7 sites across 1 country: Norway