Coronavirus Pediatric Serological Study

SARS-CoV2 Infection Clinical Trial

— CoPSS  

Official title:

Coronavirus Pediatric Serological Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05128435
• Other study ID #: 200629
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: November 2021
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 179 Months

Eligibility

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:

• /

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV2 Infection

Intervention

Diagnostic Test:
• Blood sample
Blood sample taken 3 to 5 months after the infection

Locations

Country	Name	City	State
Belgium	Saint-Pierre Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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