NCT05128435

Brief Summary

The Coronavirus Pediatric Serological Study's aim is to provide a better insight of children's immune response after SARS-CoV-2 infection. Serological tests were conducted on blood samples taken 3 to 5 months after the children's viral infection. The study was performed in collaboration with the Institute of Medical Immunology, were antibody levels were measured and immunoglobulin subclasses profiles were studied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

October 28, 2021

Last Update Submit

November 9, 2021

Conditions

Keywords

SARS-CoV-2Immune responseChildren

Outcome Measures

Primary Outcomes (3)

  • SARS-CoV-2 antibody levels in asymptomatic patients

    Measurement of SARS-CoV-2 IgG (total and subclasses), IgA (total and subclasses) and IgM levels in the sera of children who did not show any symptoms at the time of the viral infection

    3 to 5 months after SARS-CoV-2 infection

  • SARS-CoV-2 antibody levels in mildly symptomatic patients

    Measurement of SARS-CoV-2 IgG (total and subclasses), IgA (total and subclasses) and IgM levels in the sera of children presenting mild symptoms at the time of the viral infection

    3 to 5 months after SARS-CoV-2 infection

  • SARS-CoV-2 antibody levels in hospitalized patients

    Measurement of SARS-CoV-2 IgG (total and subclasses), IgA (total and subclasses) and IgM levels in the sera of children who required an hospitalisation at the time of the viral infection

    3 to 5 months after SARS-CoV-2 infection

Study Arms (1)

Positive Children

Children under 15 years old tested positive for SARS-CoV-2 by PCR on nasopharyngeal swab

Diagnostic Test: Blood sample

Interventions

Blood sampleDIAGNOSTIC_TEST

Blood sample taken 3 to 5 months after the infection

Positive Children

Eligibility Criteria

Age0 Months - 179 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children under 15 years old

You may qualify if:

  • \- Tested positive for SARS-CoV-2 by PCR on naso-pharyngeal swab performed in Saint-Pierre Hospital (Brussels) between March 1 2020 and December 31 2020

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint-Pierre Hospital

Brussels, 1000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor (pediatrician)

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 22, 2021

Study Start

March 1, 2020

Primary Completion

December 31, 2020

Study Completion

May 31, 2021

Last Updated

November 22, 2021

Record last verified: 2021-11

Locations