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

Sponsor
University Hospital, Akershus (Other)
Overall Status
Recruiting
CT.gov ID
NCT04335773
Collaborator
St. Olavs Hospital (Other), Helse Stavanger HF (Other), Haukeland University Hospital (Other), University Hospital of North Norway (Other), Alesund Hospital (Other), Norwegian Institute of Public Health (Other), The University of New South Wales (Other), University of Bristol (Other), Sykehuset Ostfold (Other), Nordlandssykehuset HF (Other), Vestre Viken Hospital Trust (Other), Helse Fonna (Other), Helse Nord-Trøndelag HF (Other), Oslo University Hospital (Other), Sykehuset Innlandet HF (Other)
350
Enrollment
1
Location
128.9
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    350 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    COVID-19 in Hospitalised Norwegian Children - Risk Factors, Outcomes and Immunology
    Actual Study Start Date :
    Apr 3, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2030
    Anticipated Study Completion Date :
    Dec 31, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    Sars-CoV-2 positive

    Children positive for SARS-CoV-2
    SARS-CoV-2 negative

    Children negative SARS-CoV-2

    Outcome Measures

    Primary Outcome Measures

    1. Risk Factors for severe infection [2030]

      Identify comorbidities predisposing for severe infection

    2. Immunulogical mechanisms [2030]

      Immunological response to acute infection, focusing on initial innate host response and its associations to inflammatory enhancement, genetic factors and clinical course.

    3. Long term outcome [2030]

      prevalence and risk factors of long-lasting complication, in particular the development of post-infectious chronic fatigue

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Suspected covid-19 infection and age 0-18 years

    Exclusion Criteria:

    Age >18 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Akershus universistetssykehus Lørenskog Norway

    Sponsors and Collaborators

    • University Hospital, Akershus
    • St. Olavs Hospital
    • Helse Stavanger HF
    • Haukeland University Hospital
    • University Hospital of North Norway
    • Alesund Hospital
    • Norwegian Institute of Public Health
    • The University of New South Wales
    • University of Bristol
    • Sykehuset Ostfold
    • Nordlandssykehuset HF
    • Vestre Viken Hospital Trust
    • Helse Fonna
    • Helse Nord-Trøndelag HF
    • Oslo University Hospital
    • Sykehuset Innlandet HF

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christopher Inchley, Principal investigator, University Hospital, Akershus
    ClinicalTrials.gov Identifier:
    NCT04335773
    Other Study ID Numbers:
    • 20/03794
    First Posted:
    Apr 6, 2020
    Last Update Posted:
    Feb 16, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Respiration Disorders
    Respiratory Tract Diseases

    Study Results

    No Results Posted as of Feb 16, 2022