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Recruiting NCT04335773

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

Observational Pediatric Respiratory Diseases COVID Fatigue Post Viral

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pediatric Respiratory Diseases, COVID, Fatigue Post Viral. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Primary outcome measures

  • Risk Factors for severe infection [Time frame: 2030]
  • Immunulogical mechanisms [Time frame: 2030]
  • Long term outcome [Time frame: 2030]

Eligibility criteria

Inclusion criteria

Suspected covid-19 infection and age 0-18 years

Exclusion criteria

Age >18 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Norway · 1 center
  • Akershus universistetssykehus — Lørenskog

Identifiers

NCT: NCT04335773 · 20/03794

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗