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Completed

NCT Number: NCT05128435

Coronavirus Pediatric Serological Study

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.

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Key information

Conditions

SARS-CoV2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

0 month–179 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint-Pierre Hospital

Brussels, 1000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • /

Treatment and study plan

Blood sample

Diagnostic Test

Blood sample taken 3 to 5 months after the infection

Primary outcomes

  1. 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

  2. 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. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Registry information

Acronym: CoPSS

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Nov 22, 2021
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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