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

Severe Acute Respiratory Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04381819
• Other study ID #: 20-04072
• Status: Recruiting
• Start date: March 2, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2020
• Source: Oslo University Hospital
• Contact: Jan C Holter, PhD
• Phone: +4791195761
• Email: jacaho[@]ous-hf.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2023
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Refusal of consent by patient or closest relative

Related Conditions & MeSH terms

• Coronavirus Infections
• SARS Virus
• Severe Acute Respiratory Syndrome

Intervention

Diagnostic Test:
• SARS-CoV-2 PCR
SARS-CoV-2 E gene

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Vestre Viken Drammen Hospital	Drammen	Viken
Norway	Østfold Hospital Trust	Fredrikstad
Norway	Akershus University Hospital	Lørenskog
Norway	Oslo University Hospital	Oslo
Norway	University Hospital North Norway	Tromsø
Norway	St Olavs Hospital	Trondheim

Sponsors (7)

Lead Sponsor	Collaborator
Oslo University Hospital	Haukeland University Hospital, Østfold Hospital Trust, St. Olavs Hospital, University Hospital of North Norway, University Hospital, Akershus, Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Fatal outcome from COVID-19	From date of randomization until the date of death from any cause assessed up to 3 months.
Primary	Recovery from COVID-19	Resolved infection	From date of randomization until the date of recovery from COVID-19 symptoms assessed up to 3 months.
Primary	Progression to ICU care or ventilation	Percentage of patients requiring intensive care admission or ventilation	30 days
Secondary	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
Secondary	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.