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NCT04335773 Clinical Trial

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

COVID Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04335773
Other study ID # 20/03794
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 3, 2020
Est. completion date December 31, 2030

Study information
Verified date February 2022
Source University Hospital, Akershus
Contact Christopher Inchley, Phd
Phone 90069276
Email chris.inchley@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 350
Est. completion date December 31, 2030
Est. primary completion date December 31, 2030
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: Suspected covid-19 infection and age 0-18 years Exclusion Criteria: Age >18 years

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Akershus universistetssykehus Lørenskog

Sponsors (16)
Lead Sponsor Collaborator
University Hospital, Akershus 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

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Risk Factors for severe infection Identify comorbidities predisposing for severe infection 2030
Primary Immunulogical mechanisms Immunological response to acute infection, focusing on initial innate host response and its associations to inflammatory enhancement, genetic factors and clinical course. 2030
Primary Long term outcome prevalence and risk factors of long-lasting complication, in particular the development of post-infectious chronic fatigue 2030
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