Presence of antibodies in children and young adults living with at least one SARS-CoV-2 positive person

ISRCTN ISRCTN91064601
DOI https://doi.org/10.1186/ISRCTN91064601
Secondary identifying numbers CE15052020
Submission date
16/10/2020
Registration date
16/12/2020
Last edited
25/03/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.

In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.

Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.

Children appear to be less vulnerable to coronavirus and particular attention must be paid to family clusters. The aim of this study is to evaluate young people aged between 4 and 16, belonging to families with at least one positive swab result for this virus.

Who can participate?
Young people aged 4 to 16 years, who live with at least one person who has tested positive for SARS-CoV-2 infection.

What does the study involve?
The study involves a preliminary phone interview and subsequently a test for the detection of antibodies for SARS-CoV-2.

What are the possible benefits and risks of participating?
None. This study could be useful for the participants and for the whole community to gain information about their health condition and the impact of COVID-19 on children.

Where is the study run from?
University of Milan (Italy)

When is the study starting and how long is it expected to run for?
March 2020 to August 2020

Who is funding the study?
University of Milan (Italy)

Who is the main contact?
Prof. Giampetro Farronato, giampietro.farronato@unimi.it)
Prof. Gianluca Tartaglia, gianluca.tartaglia@unimi.it

Contact information

Prof Gianluca Tartaglia
Scientific

Via Martiri della Libertà, 58
Segrate
20090
Italy

ORCiD logoORCID ID 0000-0001-7062-5143
Phone +39 (0)2 2692 1196
Email gianluca.tartaglia@unimi.it
Prof Gianluca Tartaglia
Public

Via Martiri della Libertà, 58
Segrate
20090
Italy

ORCiD logoORCID ID 0000-0001-7062-5143
Phone +39 (0)2 2692 1196
Email gianluca.tartaglia@unimi.it

Study information

Study designObservational cross sectional
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Community
Study typeScreening
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet.
Scientific titleEvaluation of the serological profile of subjects aged between 4 and 16 years old with at least one SARS-CoV-2 positive cohabitant: a randomized clinical trial
Study objectivesChildren aged between 4 and 16 years with at least a positive cohabitant are less vulnerable to covid infection than adults
Ethics approval(s)Approved 18/06/2020, Università degli Studi di Milano (Via Carducci 18, Milano CAP 20129, Italy; +39 (0)254100378; firm@tascalawfirm.com), ref: IRB15052020
Health condition(s) or problem(s) studiedDetection of IgG and IgM antibodies for Sars-Cov-2 in children aged between 4 and 16 years
InterventionFamilies 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 positive subject (i.e. sex, age, risk exposure during the lockdown, course of the disease, symptoms suggestive of COVID-19) and children aged between 4 and 16 y.o. (i.e. sex, age, risk exposure during the lockdown, drug therapy and/or chronic diseases, symptoms suggestive of COVID-19)

Children undergo a rapid lateral flow chromatographic test for the detection of IgG and IgM antibodies for Sars-Cov-2
Intervention typeOther
Primary outcome measurePresence of IgG and IgM antibodies for Sars-Cov-2 using a rapid lateral flow chromatographic test at a single time point.
Secondary outcome measures1. Age measured at the time of serological test
2. Days from negativization measured at the time of serological test (measured by asking the positive subject for the date of certified negativization [after two negative swabs])
Overall study start date15/03/2020
Completion date06/08/2020

Eligibility

Participant type(s)Healthy volunteer
Age groupMixed
SexBoth
Target number of participants49
Total final enrolment49
Key inclusion criteria1. Between 4 and 16 years old
2. At least one cohabitant with positive result of Sars-Cov-2
3. From the districts of Segrate (MI), Vimodrone (MI), Peschiera Borromeo (MI), Crema (CR), and Lodi (LO)
Key exclusion criteriaDoes not consent to take part
Date of first enrolment12/06/2020
Date of final enrolment05/08/2020

Locations

Countries of recruitment

  • Italy

Study participating centre

University of Milan
Department of Biomedical, Surgical and Dental Sciences
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
via Francesco Sforza, 35
Milan
20122
Italy

Sponsor information

University of Milan
Hospital/treatment centre

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Department of Biomedical, Surgical and Dental Sciences.
Via Francesco Sforza, 35
Milan
20122
Italy

Phone +39 (0)250320240
Email specialitaortognatodonzia@unimi.it
Website http://www.unimi.it/ENG/
ROR logo "ROR" https://ror.org/00wjc7c48

Funders

Funder type

University/education

Università degli Studi di Milano
Private sector organisation / Universities (academic only)
Alternative name(s)
Universitas Studiorum Mediolanensis, University of Milan, La Statale, UniMi
Location
Italy

Results and Publications

Intention to publish date06/06/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available due to lack of consent to share.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 04/02/2021 25/03/2021 Yes No

Editorial Notes

25/03/2021: Publication reference added.
30/10/2020: Trial’s existence confirmed by Università degli Studi di Milano.