Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04615000 |
| Other study ID # |
BC-08104 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 29, 2020 |
| Est. completion date |
November 1, 2021 |
Study information
| Verified date |
November 2020 |
| Source |
University Hospital, Ghent |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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.
