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NCT Number: NCT04335773

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

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

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Key information

Conditions

Pediatric Respiratory Diseases COVID Fatigue Post Viral

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus universistetssykehus

Lørenskog, Norway

Location status: Recruiting

Location contact

Lise Beier Havdal

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Suspected covid-19 infection and age 0-18 years

Exclusion criteria

Age >18 years

Treatment and study plan

Primary outcomes

  1. Risk Factors for severe infection

    Time frame: 2030

    Identify comorbidities predisposing for severe infection

  2. Immunulogical mechanisms

    Time frame: 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

    Time frame: 2030

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

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Inchley, Phd

CONTACT

[email protected]

90069276

Lise Beier Havdal

CONTACT

[email protected]

45663188

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

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

Registry information

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Apr 6, 2020
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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