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

Sponsor
University of Milan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04649944
Collaborator
(none)
40
1
10.8
3.7

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Serological test and phone interview

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
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
Anticipated Study Start Date :
Feb 5, 2021
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Outcome Measures

Primary Outcome Measures

  1. Detection of IgG and IgM antibodies for Sars-Cov-2 in children aged between 4 and 16 y.o. cohabiting with at least a subject with a previous diagnosis of COVID-19. [1-30 days]

    Assessment of IgG and IgM using serological tests at a single time point.

Secondary Outcome Measures

  1. Detection of IgG and IgM antibodies for Sars-Cov-2 in adults with a previous diagnosis of COVID-19 cohabiting with at least a child aged between 4 and 16 y.o. [1-30 days]

    Assessment of IgG and IgM using serological tests at a single time point.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Children and young adults aged between 4 and 16 years old with at least a Sars-Cov-2 positive cohabitant

  2. Adults who previously tested positive to SARS-CoV-2 with at least a cohabitant aged between 4 and 16 y.o.

  3. Subjects from the district of Sesto San Giovanni, Lombardy, Italy

Exclusion Criteria:
  1. Children and young adults aged between 4 and 16 years old without at least a cohabitant who previously tested positive to SARS-CoV-2

  2. Adults who previously tested positive to SARS-CoV-2 without at least a cohabitant aged between 4 and 16 y.o.

  3. Absence of a signed informed consent

  4. Subject with symptoms suggestive of COVID-19 in the last 14 days or disease in progress

Contacts and Locations

Locations

Site City State Country Postal Code
1 UOC Maxillofacial Surgery and Odontology, University of Milan Milan Lombardy Italy 20122

Sponsors and Collaborators

  • University of Milan

Investigators

  • Study Director: Giampietro Farronato, DDS, University of Milan

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Marco Farronato, Principal Investigator, University of Milan
ClinicalTrials.gov Identifier:
NCT04649944
Other Study ID Numbers:
  • GMT_CD_CT_LG_EB_10_2020
First Posted:
Dec 2, 2020
Last Update Posted:
Dec 22, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marco Farronato, Principal Investigator, University of Milan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 22, 2020