Coronavirus Pediatric Serological Study (CoPSS)

November 9, 2021 updated by: Lisa Tomasi, Centre Hospitalier Universitaire Saint Pierre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The hospital laboratory provided us the list of children under 15 years old tested for SARS-CoV-2 in Saint-Pierre Hospital (Brussels) by PCR on nasopharyngeal swab between March 1 2020 and December 31 2020.

The medical files of all children that were tested positive for SARS-CoV-2 were reviewed and clinical information was collected.

For each positive child, the family was contacted by phone 3 months after the proven viral infection in order to ask permission to take a single blood test.

Covid19 serologies were performed in the hospital laboratory, and blood samples were then sent to the Institute of Medical Immunology, were antibody levels and immunoglobulin subclasses were studied.

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Saint-Pierre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 14 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children under 15 years old

Description

Inclusion Criteria:

- 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

Exclusion Criteria:

  • /

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Positive Children
Children under 15 years old tested positive for SARS-CoV-2 by PCR on nasopharyngeal swab
Diagnostic test: Blood sample
Blood sample taken 3 to 5 months after the infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 antibody levels in asymptomatic patients
Time Frame: 3 to 5 months after SARS-CoV-2 infection
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
Time Frame: 3 to 5 months after SARS-CoV-2 infection
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
Time Frame: 3 to 5 months after SARS-CoV-2 infection
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2020

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

May 31, 2021

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (ACTUAL)

November 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200629

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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