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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04649944
• Other study ID #: GMT_CD_CT_LG_EB_10_2020
• Status: Not yet recruiting
• Start date: February 5, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: University of Milan
• Contact: Gianluca Martino Tartaglia, DDS PhD
• Phone: 00393471661738
• Email: gianluca.tartaglia[@]unimi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

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.

Locations

Country	Name	City	State
Italy	UOC Maxillofacial Surgery and Odontology, University of Milan	Milan	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24. — View Citation

Ludvigsson JF. Systematic review of COVID-19 in children shows milder cases and a better prognosis than adults. Acta Paediatr. 2020 Jun;109(6):1088-1095. doi: 10.1111/apa.15270. Epub 2020 Apr 14. — View Citation

Saleem H, Rahman J, Aslam N, Murtazaliev S, Khan S. Coronavirus Disease 2019 (COVID-19) in Children: Vulnerable or Spared? A Systematic Review. Cureus. 2020 May 20;12(5):e8207. doi: 10.7759/cureus.8207. Review. — View Citation

Sun D, Zhu F, Wang C, Wu J, Liu J, Chen X, Liu Z, Wu Z, Lu X, Ma J, Peng H, Xiao H. Children Infected With SARS-CoV-2 From Family Clusters. Front Pediatr. 2020 Jun 23;8:386. doi: 10.3389/fped.2020.00386. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessment of IgG and IgM using serological tests at a single time point.	1-30 days
Secondary	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.	Assessment of IgG and IgM using serological tests at a single time point.	1-30 days