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.
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.
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.
- Conditions
- Covid19, Children, Only
- 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.
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)
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
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.
- First posted4 Nov 2020
- Study start29 Oct 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Filomeen Haerynck, MD, PhD, Principal investigator, University Hospital, Ghent
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SeroCovid<19: A Prospective Covid-19 Seroconversion Study in a Tertiary Pediatric Patient Cohort
- ClinicalTrials.gov ID
- NCT04615000
- Acronym / sponsor ID
- BC-08104
- Conditions
- Covid19, Children, Only
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 serological assessment (IgG)Periodic assessment of the serology status (SARS-CoV-2 specific IgG) with a 3 to 6 month interval | Diagnostic test | – |
Primary outcome
Seroconversion rate of children with chronic conditions followed in a tertiary centre
Time frame: 12-18 months
Prospective follow-up of the COVID-19 seroconversion rate (serum IgG) of children with chronic conditions followed in a tertiary centre
2 secondary outcomes
Epidemiological and social determinants of SARS-CoV-2 infection risk in children with chronic conditions
Time frame: 12-18 months
Clinical manifestations of COVID-19 in children with chronic conditions
Time frame: 12-18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filomeen Haerynck, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
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.