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

• Conditions: Severe Acute Respiratory Syndrome; SARS Virus

• Registration Number: NCT04381819
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2020-03-02
• Status Verified: 2020-05
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-08
• Last Update Submitted: 2020-05-08
• Study First Posted: 2020-05-11
• Last Update Posted: 2020-05-11
• Primary Completion: 2022-02-28
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Confirmed COVID-19 by screening of SARS-CoV-2 E-gene

Exclusion Criteria

• Refusal of consent by patient or closest relative

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (7)

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Østfold Hospital Trust; 🇳🇴 Fredrikstad, Norway

Vestre Viken Drammen Hospital; 🇳🇴 Drammen, Viken, Norway

Oslo University Hospital; 🇳🇴 Oslo, Norway

Akershus University Hospital; 🇳🇴 Lørenskog, Norway

University Hospital North Norway; 🇳🇴 Tromsø, Norway

St Olavs Hospital; 🇳🇴 Trondheim, Norway