COVID-19 in Hospitalised Norwegian Children - Risk Factors, Outcomes and Immunology

NCT ID: NCT04335773

Last Updated: 2022-02-16

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

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-03

Study Completion Date

2030-12-31

Brief Summary

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Prospective cohort study of COVID-19 infection among children in Norway.

Detailed Description

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This nation-wide, prospective cohort study of COVID-19 infection addresses three main issues: 1) Epidemiological risk factors; 2) Natural history (including immunological mechanisms and long term effects) and 3) Support of infection prevention. Also, the study focuses solely on children.

Children (0-18 years of age) admitted to hospital with suspected COVID-19 are eligible (Fig. 1). Those with confirmed COVID-19 serve as cases, whereas those with non-COVID-19 serve as controls; both groups will be followed prospectively for 6 months. Three objectives/Work Packages (WPs) are defined:

* In WP1, the investigators will investigate risk factors for severe outcome of the acute infection; potential risk factors include sex, age, comorbidities, initial clinical findings, infectious load, and genetic markers.
* In WP2, the investigators will investigate the immunological response to acute infection, focusing on initial innate host response and its associations to inflammatory enhancement, genetic factors and clinical course.
* In WP3, the investigators will investigate the prevalence and risk factors of long-lasting complication, in particular the development of post-infectious chronic fatigue

Conditions

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Pediatric Respiratory Diseases COVID Fatigue Post Viral

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Sars-CoV-2 positive

Children positive for SARS-CoV-2

No interventions assigned to this group

SARS-CoV-2 negative

Children negative SARS-CoV-2

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Suspected covid-19 infection and age 0-18 years

Exclusion Criteria

Age \>18 years
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role collaborator

Alesund Hospital

OTHER

Sponsor Role collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role collaborator

The University of New South Wales

OTHER

Sponsor Role collaborator

University of Bristol

OTHER

Sponsor Role collaborator

Sykehuset Ostfold

OTHER

Sponsor Role collaborator

Nordlandssykehuset HF

OTHER

Sponsor Role collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role collaborator

Helse Fonna

OTHER

Sponsor Role collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role lead

Responsible Party

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Christopher Inchley

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Akershus universistetssykehus

Lørenskog, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Christopher Inchley, Phd

Role: CONTACT

Lise Beier Havdal

Role: CONTACT

Facility Contacts

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Lise Beier Havdal

Role: primary

Other Identifiers

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20/03794

Identifier Type: -

Identifier Source: org_study_id

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