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

NCT ID: NCT04381819

Last Updated: 2020-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-02

Study Completion Date

2023-12-31

Brief Summary

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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

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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

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SARS Virus Severe Acute Respiratory Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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SARS-CoV-2 PCR

SARS-CoV-2 E gene

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Refusal of consent by patient or closest relative
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Akershus

OTHER

Sponsor Role collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role collaborator

Ostfold Hospital Trust

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jan Cato Holter

Project leader, medical doctor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fredrik G Müller, Professor

Role: STUDY_DIRECTOR

University of Oslo

Susanne G Dudman, Professor

Role: STUDY_CHAIR

University of Oslo

Jan C Holter, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Vestre Viken Drammen Hospital

Drammen, Akershus, Norway

Site Status RECRUITING

Haukeland University Hospital

Bergen, , Norway

Site Status RECRUITING

Østfold Hospital Trust

Fredrikstad, , Norway

Site Status RECRUITING

Akershus University Hospital

Lørenskog, , Norway

Site Status RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

University Hospital North Norway

Tromsø, , Norway

Site Status RECRUITING

St Olavs Hospital

Trondheim, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Jan C Holter, PhD

Role: CONTACT

+4791195761 ext. +4723071155

Susanne G Dudman, PhD

Role: CONTACT

+4723071155 ext. +4723071155

Facility Contacts

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Lars Heggelund, PhD

Role: primary

Role: backup

Bjørn Blomberg, PhD

Role: primary

Jonas Bergan, phd

Role: primary

Christian Prebensen, PhD

Role: primary

Jan C Holter, PhD

Role: primary

+4791195761 ext. +4791195761

Susanne G Dudman, Ass.Professor

Role: backup

+4791195761 ext. +4791195761

Anders B Kildal, PhD

Role: primary

Erik Solligård, PhD

Role: primary

References

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Troseid M, Holter JC, Holm K, Vestad B, Sazonova T, Granerud BK, Dyrhol-Riise AM, Holten AR, Tonby K, Kildal AB, Heggelund L, Tveita A, Boe S, Muller KE, Jenum S, Hov JR, Ueland T; Norwegian SARS-CoV-2 study group. Gut microbiota composition during hospitalization is associated with 60-day mortality after severe COVID-19. Crit Care. 2023 Feb 23;27(1):69. doi: 10.1186/s13054-023-04356-2.

Reference Type DERIVED
PMID: 36814280 (View on PubMed)

Tveita A, Murphy SL, Holter JC, Kildal AB, Michelsen AE, Lerum TV, Kaarbo M, Heggelund L, Holten AR, Finbraten AK, Muller KE, Mathiessen A, Boe S, Fevang B, Granerud BK, Tonby K, Lind A, Dudman SG, Henriksen KN, Muller F, Skjonsberg OH, Troseid M, Barratt-Due A, Dyrhol-Riise AM, Aukrust P, Halvorsen B, Dahl TB, Ueland T; NOR-SOLIDARITY Consortium and the Norwegian SARS-CoV-2 Study Group Investigators. High Circulating Levels of the Homeostatic Chemokines CCL19 and CCL21 Predict Mortality and Disease Severity in COVID-19. J Infect Dis. 2022 Dec 13;226(12):2150-2160. doi: 10.1093/infdis/jiac313.

Reference Type DERIVED
PMID: 35876699 (View on PubMed)

Other Identifiers

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20-04072

Identifier Type: -

Identifier Source: org_study_id

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