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

February 14, 2022 updated by: Christopher Inchley, University Hospital, Akershus
Prospective cohort study of COVID-19 infection among children in Norway.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children seeking hospital care i Norway

Description

Inclusion Criteria:

Suspected covid-19 infection and age 0-18 years

Exclusion Criteria:

Age >18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Sars-CoV-2 positive
Children positive for SARS-CoV-2
SARS-CoV-2 negative
Children negative SARS-CoV-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk Factors for severe infection
Time Frame: 2030
Identify comorbidities predisposing for severe infection
2030
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.
2030
Long term outcome
Time Frame: 2030
prevalence and risk factors of long-lasting complication, in particular the development of post-infectious chronic fatigue
2030

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Akershus

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2020

Primary Completion (Anticipated)

December 31, 2030

Study Completion (Anticipated)

December 31, 2030

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 3, 2020

First Posted (Actual)

April 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20/03794

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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