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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Children, Only
• Intervention / Treatment: Diagnostic test: SARS-CoV-2 serological assessment (IgG)

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 Type: Observational
• Enrollment (Actual): 362

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	12-18 months

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent
• Investigators: Principal Investigator: Filomeen Haerynck, MD, PhD, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2020
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: BC-08104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No