NCT04615000

Brief Summary

Children are relatively spared from the direct clinical impact of COVID-19. Pediatric patients with regular follow-up at tertiary pediatric centres and presenting one or more chronic conditions might be at increased risk for severe COVID-19. With a prospective seroprevalence study, we aim to study COVID-19 incidence, disease course and risk factors associated with SARS-CoV-2 infection in this specific context.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
362

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 29, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

July 1, 2022

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

November 3, 2020

Last Update Submit

June 27, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Seroconversion rate of children with chronic conditions followed in a tertiary centre

    Prospective follow-up of the COVID-19 seroconversion rate (serum IgG) of children with chronic conditions followed in a tertiary centre

    12-18 months

Secondary Outcomes (2)

  • Epidemiological and social determinants of SARS-CoV-2 infection risk in children with chronic conditions

    12-18 months

  • Clinical manifestations of COVID-19 in children with chronic conditions

    12-18 months

Interventions

Periodic assessment of the serology status (SARS-CoV-2 specific IgG) with a 3 to 6 month interval

Eligibility Criteria

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

* children \<18 years of age * a clearly defined chronic condition requiring follow-up at the tertiary pediatric hospital of the Ghent University Hospital

You may qualify if:

  • children \<18 years of age
  • a clearly defined chronic condition requiring follow-up at the tertiary pediatric hospital of the Ghent University Hospital
  • routine blood sampling planned per 3 to 6 months

You may not qualify if:

  • no clear diagnosis or reason for follow-up at the Ghent University Hospital
  • no routine blood sampling planned
  • unable to understand or provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Filomeen Haerynck, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 4, 2020

Study Start

October 29, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

July 1, 2022

Record last verified: 2020-11

Locations