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Covid19NCT04615000

SeroCovid<19: Covid-19 Seroconversion in Tertiary Pediatric Patients

An observational study of Covid19 and Children, Only, run by University Hospital, Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Covid19, Children, Only
What is being tested?
SARS-CoV-2 serological assessment (IgG)
How many people
362 participants
Where
1 siteBelgium
Study dates
29 Oct 2020to 1 Nov 2021
How long will I take part?
18 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Ghent University Hospital

    Ghent, 9000

Other trials in Belgium

About this study

Official title: SeroCovid<19: A Prospective Covid-19 Seroconversion Study in a Tertiary Pediatric Patient Cohort

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.

Read the detailed description

Children and adolescents seem to be relatively spared from severe SARS-CoV-2 infection. Throughout the course of the COVID-19 pandemic, these findings were confirmed with, for example, also in Belgium only 1.8% of the confirmed infections, 1.6% of the hospitalizations in intensive care, and 0.011% of the deaths from COVID-19 attributed to children by the end of May 2020. Multiple immunological hypotheses (ACE2 expression, lymphocyte repertoire, cross immunization) have been suggested without one clear explanation to date. In addition, children seem to play a limited role in the spread of the virus and are not considered the "engine of the epidemic".

Population seroconversion studies have been initiated with the determination of antibodies to SARS-CoV-2. For Belgium, seroconversion rates were estimated at around 2.1% at the end of March, 4.3% in mid-April, 6% at the beginning of May and 6.9% at the end of May 2020, comparable to international studies. However, even with these prospective studies, it remained unclear whether the seroconversion rate in children is comparable to adults. In addition, it has not yet been demonstrated whether the mild course and limited hospitalizations in children are related to either a mild course or (in part) also to a lack of exposure to SARS-CoV-2 and therefore limited seroconversion in children.

With this study we aim to monitor both the presence of antibodies (serology) in children with chronic disease, followed in a tertiary hospital in Belgium, combined with the registration of the clinical course of COVID-19 in this population. In addition, we want to correlate the social activities with the risk of exposure to the virus and subsequent seroconversion. Blood samples for serology are performed at a 3- to 6-month interval, linked to an already planned blood sample for diagnostic reasons. This data will allow to gain more insight into the actual rate of infection and the symptoms caused by COVID-19 in children with a chronic disease, on the one hand, and, on the other hand, how the social behavior, limited by the lockdown measures or after its progressive relaxation, affects seroconversion in these pediatric populations. These data may or may not confirm current hypotheses about infection rate and clinic severity and will also influence current and future policies such as closing schools and defining at-risk populations.

Being tested
SARS-CoV-2 serological assessment (IgG)
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARS-CoV-2 serological assessment (IgG)Diagnostic test

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12-18 months

Secondary outcomes (2)
  1. Epidemiological and social determinants of SARS-CoV-2 infection risk in children with chronic conditions

    Questionnaire assessment of the epidemiological (household, school,... infections) and social determinants (school, daycare, sport participation,...) of SARS-CoV-2 infection risk in children with chronic conditions

    Measured: 12-18 months

  2. Clinical manifestations of COVID-19 in children with chronic conditions

    Questionnaire assessment of COVID-19 associated symptoms in the subcohort of patients with seroconversion

    Measured: 12-18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2020
  2. Study start29 Oct 2020
  3. Primary completion1 Nov 2021
  4. Study completion1 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
362 participants (actual)
Target duration
18 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04615000
Sponsor's protocol ID
BC-08104
Status last verified
Nov 2020
First submitted
3 Nov 2020
Last updated
1 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Children, Only, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion rate of children with chronic conditions followed in a tertiary centre (time frame: 12-18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.

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