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

U

University Hospital, Akershus

Status

Enrolling

Conditions

Fatigue Post Viral
COVID
Pediatric Respiratory Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT04335773
20/03794

Details and patient eligibility

About

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

Full 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

Enrollment

350 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Suspected covid-19 infection and age 0-18 years

Exclusion criteria

Age >18 years

Trial design

350 participants in 2 patient groups

Sars-CoV-2 positive
Description:
Children positive for SARS-CoV-2
SARS-CoV-2 negative
Description:
Children negative SARS-CoV-2

Trial contacts and locations

1

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Central trial contact

Christopher Inchley, Phd; Lise Beier Havdal

Data sourced from clinicaltrials.gov

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