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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• COVID
• Fatigue Post Viral
• Pediatric Respiratory Diseases
• Respiration Disorders
• Respiratory Tract Diseases

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