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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | CE15052020 |
| Sponsor | University of Milan |
| Funder | Università degli Studi di Milano |
- 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
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
Scientific
Via Martiri della Libertà, 58
Segrate
20090
Italy
 ORCID ID |
0000-0001-7062-5143 |
|---|---|
| Phone | +39 (0)2 2692 1196 |
| gianluca.tartaglia@unimi.it |
Public
Via Martiri della Libertà, 58
Segrate
20090
Italy
| ORCID ID |
0000-0001-7062-5143 |
|---|---|
| Phone | +39 (0)2 2692 1196 |
| gianluca.tartaglia@unimi.it |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross sectional |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Evaluation 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 objectives | Children 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) studied | Detection of IgG and IgM antibodies for Sars-Cov-2 in children aged between 4 and 16 years |
| Intervention | Families 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 type | Other |
| Primary outcome measure(s) |
Presence of IgG and IgM antibodies for Sars-Cov-2 using a rapid lateral flow chromatographic test at a single time point. |
| Key secondary outcome measure(s) |
1. Age measured at the time of serological test |
| Completion date | 06/08/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 49 |
| Total final enrolment | 49 |
| Key inclusion criteria | 1. 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 criteria | Does not consent to take part |
| Date of first enrolment | 12/06/2020 |
| Date of final enrolment | 05/08/2020 |
Locations
Countries of recruitment
- Italy
Study participating centre
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
via Francesco Sforza, 35
Milan
20122
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/03/2021: Publication reference added.
30/10/2020: Trial’s existence confirmed by Università degli Studi di Milano.
