NCT04649944

Serological Profile of Children and Young Adolescents With at Least One COVID-19 Diagnosed Family Member

Assessment of the Serological Profile of Children and Adolescents Between 4 and 16 Years of Age Cohabiting With at Least One Family Member Who Tested Positive to COVID-19: an Observational Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 4 Years – 99 Years
• Healthy volunteers: Accepted

Summary

Use of rapid serological tests to assess the vulnerability to SARS-CoV-2 infection of subjects aged 4-16 years old and cohabiting with at least one family member who tested positive to SARS-CoV-2

Detailed description

Families with at least one child or young adult aged between 4 and 16 years old and with at least one cohabitant who tested positive to nasopharyngeal swab are contacted by phone. Those who decide to sign an informed consent after reading the study information will be included in the study. It consists of a preliminary telephone interview and a following rapid serological test for all children and young adults with the age included in the range of interest and the cohabitant who tested positive to nasopharingeal swab. The obtained results will be collected and analysed, and the outcomes of the study will be measured.

Conditions

• Covid19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Serological test and phone interview	Families are interviewed by telephone to gather information about the family cluster (i.e. age and number of cohabitants, their symptoms and swab results, if performed), the subject who tested positive (i.e.sex, age, course of the disease, symptoms suggestive of COVID-19) and children aged between 4 and 16 y.o. (i.e. sex, age, drug therapy and/or chronic diseases, symptoms suggestive of COVID-19). Children, young adults and the cohabitant who previously tested positive to the swab undergo a serological test for the detection of IgG and IgM antibodies for Sars-Cov-2.

Timeline

• Start date: 2021-02-05
• Primary completion: 2021-11-01
• Completion: 2021-12-31
• First posted: 2020-12-02
• Last updated: 2020-12-22

Locations

1 site across 1 country: Italy