NCT04335773

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Apr 2020Dec 2030

First Submitted

Initial submission to the registry

April 3, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

10.8 years

First QC Date

April 3, 2020

Last Update Submit

February 14, 2022

Conditions

Pediatric Respiratory DiseasesCOVIDFatigue Post Viral

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Sars-CoV-2 positive

Children positive for SARS-CoV-2

SARS-CoV-2 negative

Children negative SARS-CoV-2

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children seeking hospital care i Norway

You may qualify if:

  • Suspected covid-19 infection and age 0-18 years

You may not qualify if:

  • Age \>18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus universistetssykehus

Lørenskog, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blodsamples, Eluate from nasopharyngeal sample, Urin, Feces,

Central Study Contacts

Christopher Inchley, Phd

CONTACT

90069276chris.inchley@gmail.com

Lise Beier Havdal

CONTACT

45663188lisebeierommen@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 6, 2020

Study Start

April 3, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

February 16, 2022

Record last verified: 2022-02

Locations

NO(1)