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

NCT04649944 | Unknown

• 1 other identifier: GMT_CD_CT_LG_EB_10_2020
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Keywords

Sars-Cov-2; serological test; children; young adults; positive naso-pharyngeal swab; family cluster

Outcome Measures

Primary Outcomes (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.

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

  1-30 days

Secondary Outcomes (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

Interventions

Serological test and phone interview DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 4 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children and young adults aged between 4 and 16 years old, both males and females, with at least a cohabitant who previously tested positive to SARS-CoV-2 Adults who previously tested positive to SARS-CoV-2, both males and females, with at least a cohabitant aged between 4 and 16 y.o.

You may qualify if:

• Children and young adults aged between 4 and 16 years old with at least a Sars-Cov-2 positive cohabitant
• Adults who previously tested positive to SARS-CoV-2 with at least a cohabitant aged between 4 and 16 y.o.
• Subjects from the district of Sesto San Giovanni, Lombardy, Italy

You may not qualify if:

• Children and young adults aged between 4 and 16 years old without at least a cohabitant who previously tested positive to SARS-CoV-2
• Adults who previously tested positive to SARS-CoV-2 without at least a cohabitant aged between 4 and 16 y.o.
• Absence of a signed informed consent
• Subject with symptoms suggestive of COVID-19 in the last 14 days or disease in progress

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

UOC Maxillofacial Surgery and Odontology, University of Milan

Milan, Lombardy, 20122, Italy

Location

Related Publications (4)

• 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.

  PMID: 32202343 BACKGROUND

• 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.

  PMID: 32577325 BACKGROUND

• 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.

  PMID: 31986261 BACKGROUND

• 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.

  PMID: 32656172 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will collect blood samples from subjects' finger

MeSH Terms

Conditions

COVID-19

Interventions

Serologic Tests

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Giampietro Farronato, DDS

  University of Milan

  STUDY DIRECTOR

Central Study Contacts

Gianluca Martino Tartaglia, DDS PhD

CONTACT

00393471661738; gianluca.tartaglia@unimi.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 2, 2020
• Study Start: February 5, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 31, 2021
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)