COVID-19 in Hospitalised Norwegian Children - Risk Factor... | NCT04335773

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

NCT04335773

Sponsor

University Hospital, Akershus

Status

Recruiting

Last Update Posted

Feb 16, 2022Actual

Enrollment

350Estimated

Phase

Not provided

Conditions

Pediatric Respiratory Diseases
COVID
Fatigue Post Viral

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 3, 2020Actual

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Apr 3, 2020

First Submission Date that Met QC Criteria

Apr 3, 2020

First Posted Date

Apr 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2022

Last Update Posted Date

Feb 16, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christopher Inchley, Principal investigator, University Hospital, AkershusPrincipal Investigator

Lead Sponsor

University Hospital, AkershusOTHER

Collaborators

Name	Class
St. Olavs Hospital	OTHER
Helse Stavanger HF	OTHER_GOV
Haukeland University Hospital	OTHER
University Hospital of North Norway

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

350Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sars-CoV-2 positive		Children positive for SARS-CoV-2
SARS-CoV-2 negative		Children negative SARS-CoV-2

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suspected covid-19 infection and age 0-18 years

Exclusion Criteria:

Age >18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children seeking hospital care i Norway

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christopher Inchley, Phd	Contact	90069276		chris.inchley@gmail.com
Lise Beier Havdal	Contact	45663188		lisebeierommen@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akershus universistetssykehus	Recruiting	Lørenskog			Norway