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

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ClinicalTrials.gov Identifier: NCT04615000
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
University Ghent
Information provided by (Responsible Party):
University Hospital, Ghent

Study Description
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Brief Summary:

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 (Epistat - Sciensano). Multiple immunological hypotheses (ACE2 expression, lymphocyte repertoire, cross immunization) have been suggested without one clear explanation to date (Brodin, P. Acta Paediatr. Mar 2020; Ruggiero, A et al. Acta Paediatr. Apr 2020). 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.


Condition or disease Intervention/treatment
Covid19 Children, Only Diagnostic Test: SARS-CoV-2 serological assessment (IgG)

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: SeroCovid<19: A Prospective Covid-19 Seroconversion Study in a Tertiary Pediatric Patient Cohort
Actual Study Start Date : October 29, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: SARS-CoV-2 serological assessment (IgG)
    Periodic assessment of the serology status (SARS-CoV-2 specific IgG) with a 3 to 6 month interval

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Epidemiological and social determinants of SARS-CoV-2 infection risk in children with chronic conditions [ Time Frame: 12-18 months ]
    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

  2. Clinical manifestations of COVID-19 in children with chronic conditions [ Time Frame: 12-18 months ]
    Questionnaire assessment of COVID-19 associated symptoms in the subcohort of patients with seroconversion


Biospecimen Retention:   Samples Without DNA
serum samples

Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04615000


Contacts
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Contact: Filomeen Haerynck, MD, PhD 093323581 filomeen.haerynck@uzgent.be
Contact: Levi Hoste, MD 093323581 levi.hoste@uzgent.be

Locations
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Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Filomeen Haerynck, MD, PhD    093323581    filomeen.haerynck@uzgent.be   
Contact: Levi Hoste, MD    093323581    levi.hoste@uzgent.be   
Sponsors and Collaborators
University Hospital, Ghent
University Ghent
More Information
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT04615000    
Other Study ID Numbers: BC-08104
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases