Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Gianluca Tartaglia
ORCID ID
https://orcid.org/0000-0001-7062-5143
Contact details
Via Martiri della Libertà
58
Segrate
20090
Italy
+39 (0)2 2692 1196
gianluca.tartaglia@unimi.it
Type
Public
Additional contact
Prof Gianluca Tartaglia
ORCID ID
https://orcid.org/0000-0001-7062-5143
Contact details
Via Martiri della Libertà
58
Segrate
20090
Italy
+39 (0)2 2692 1196
gianluca.tartaglia@unimi.it
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CE15052020
Study information
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
Acronym
Study hypothesis
Children aged between 4 and 16 years with at least a positive cohabitant are less vulnerable to covid infection than adults
Ethics approval
Approved 18/06/2020, Università degli Studi di Milano (Via Carducci 18, Milano CAP 20129, Italy; +39 (0)254100378; firm@tascalawfirm.com), ref: IRB15052020
Study design
Observational cross sectional
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Community
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet.
Condition
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
Phase
Drug names
Primary outcome measure
Presence of IgG and IgM antibodies for Sars-Cov-2 using a rapid lateral flow chromatographic test at a single time point.
Secondary outcome measures
1. 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 trial start date
15/03/2020
Overall trial end date
06/08/2020
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Healthy volunteer
Age group
Mixed
Gender
Both
Target number of participants
49
Total final enrolment
49
Participant exclusion criteria
Does not consent to take part
Recruitment start date
12/06/2020
Recruitment end date
05/08/2020
Locations
Countries of recruitment
Italy
Trial 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
Organisation
University of Milan
Sponsor details
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Department of Biomedical
Surgical and Dental Sciences.
Via Francesco Sforza
35
Milan
20122
Italy
+39 (0)250320240
specialitaortognatodonzia@unimi.it
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Università degli Studi di Milano
Alternative name(s)
La Statale, Universitas Studiorum Mediolanensis, University of Milan, UniMi
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Italy
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
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.
Intention to publish date
06/06/2021
Participant level data
Not expected to be available
Basic results (scientific)
Publication list