Study of COVID-19 transmission in Belgian French-speaking primary schools of the Federation Wallonia – Brussels in Belgium

ISRCTN	ISRCTN16837012
DOI	https://doi.org/10.1186/ISRCTN16837012
ClinicalTrials.gov number	NCT05046470
Secondary identifying numbers	2020/16NOV/552

Submission date: 06/04/2022
Registration date: 20/04/2022
Last edited: 27/01/2025

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
In order to limit the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the spread of coronavirus disease (COVID-19), many countries closed their schools as a preventive measure. However, there was a lack of evidence regarding the role of children in the transmission of the virus. It has been shown that the pandemic and school closures can have a significant impact on the well-being of children. In Belgium, this study invited 2488 children and 444 school attenders of 11 primary schools of the Federation Wallonia Brussels. Every participant performed a serological antibody test (finger prick) only at the inclusion date, saliva testing (PCR), and answered questionnaires for 6 weeks. This study aimed to describe the transmission dynamics of SARS-CoV-2 in the primary schools of Belgium. The results of the study should contribute to improved decision making regarding measures for schools and children in the context of current and future pandemics.

Who can participate?
Children from 6 to 12 years of age and school attenders from selected primary schools of the Federation Wallonia Brussels in Belgium

What does the study involve?
All participants (children and adults school attenders) were tested on the inclusion day with a saliva test and a rapid finger-prick blood test to measure SARS-CoV-2 antibodies. All participants were invited to fill out a questionnaire in a paperback format. Over six consecutive weeks, all participants were tested once a week with a saliva test and were invited to complete a follow-up questionnaire to assess any symptoms compatible with a SARS-CoV-2 infection or a contact with a confirmed SARS-CoV-2 case or a travelling return from a risk area.

What are the possible benefits and risks of participating?
There was no immediate direct benefit to participants. There will be benefits on future decision making regarding COVID-19 and future pandemics. The extremely rare risk was a mild finger bruise for testing.

Where is the study run from?
Université Catholique de Louvain (UCLouvain) (Belgium)

When is the study starting and how long is it expected to run for?
September 2020 to May 2025

Who is funding the study?
Federation Wallonia Brussels (Belgium)

Who is the main contact?
Prof. Annie Robert
annie.robert@uclouvain.be

Study website

Contact information

Mrs Annie Robert
Principal Investigator

Clos Chapelle-aux-Champs B1.30.13
Brussels
1200
Belgium

Phone	+32 (0)2 764 33 21
Email	annie.robert@uclouvain.be

Study information

Study design	Prospective non-interventional observational longitudinal study
Primary study design	Observational
Secondary study design	Longitudinal study
Study setting(s)	School
Study type	Screening
Participant information sheet	41519_PIS_Children.pdf
Scientific title	SARS-CoV-2 transmission in Belgian primary schools of the Federation Wallonia - Brussels: an epidemiological pilot study (DYNAtracs)
Study acronym	DYNAtracs
Study objectives	The investigators hypothesize that children are less likely to become infected in the school environment, compared to the household or outside the school setting. Primary schools do not play a major role in SARS-CoV-2 spreading. They hypothesize that the incidence level in schools is mainly a consequence of community transmission ie. the incidence level in households and that the secondary attack rate in schools remains at least five times lower than the transmission level in households.
Ethics approval(s)	Approved 20/11/2020, Hospital-Faculty Ethics Committee Saint-Luc - UCLouvain (Promenade de l’Alma 51 bte B1.43.03, 1200 Brussels, Belgium; +32(0) 2 764 55 14; commission.ethique-saintluc@uclouvain.be), ref: 2020/16NOV/552
Health condition(s) or problem(s) studied	COVID-19 (SARS-CoV-2 infection)
Intervention	Sampling procedure Each participating primary school will be considered as a cluster. Eight schools will be chosen by purposive sampling on three criteria: either high or low size of the school, a school within an area with either a high or a low incidence of SARS-CoV-2 on 06/05/2020, the first wave of COVID-19 in Belgium, and a school with either a high or a low socioeconomic level (Belgian 20-point-scale ISE index superior to thirteen or inferior to seven). As direct partners in the project, the ONE (“Office de la naissance et de l’enfance”) and the PSE teams (“Promotion de la Santé à l’Ecole”) will give a list of schools corresponding to these three criteria. All participants (children and adults school attenders) will be tested on the inclusion day with a salivary SARS-CoV2 test and a rapid serological test by finger prick (AVIOQ®) to determine the seroprevalence of SARS-CoV-2. All participants will be invited to fill out a questionnaire in a paperback format. During six consecutive weeks, all participants will be tested once a week with a salivary test and will be invited to complete a follow-up questionnaire to assess any symptom compatible with a SARS-CoV-2 infection or a contact with a confirmed SARS-CoV-2 case or a travelling from a risk area.
Intervention type	Other
Primary outcome measure	SARS-CoV-2 transmission measured by polymerase chain reaction (PCR) 6 times over 6 weeks
Secondary outcome measures	1. Seroprevalence measured using a lateral flow test (AVIOQ) by finger prick on the day of inclusion 2. Potential exposition of SARS-CoV-2 measured using questionnaires over 6 weeks
Overall study start date	01/09/2020
Completion date	31/05/2025

Eligibility

Participant type(s)	Other
Age group	Mixed
Lower age limit	6 Years
Upper age limit	12 Years
Sex	Both
Target number of participants	The expected number of children was 2400, the expected number of adult school attenders was 200, and the expected number of classes was 72.
Total final enrolment	1233
Key inclusion criteria	All children between the ages of 6 and 12 years and all school attenders from selected primary schools were invited to participate
Key exclusion criteria	Refusal to provide written informed consent before enrolment
Date of first enrolment	14/01/2021
Date of final enrolment	18/05/2021

Locations

Countries of recruitment

Belgium

Study participating centre

UCLouvain

Clos Chapelle-aux-champs, 30 bte B1.30.13
Brussels
1200
Belgium

Sponsor information

Université Catholique de Louvain
University/education

Clos Chapelle-aux-Champs B1.30.13
Brussels
1200
Belgium

Phone	+32 (0)2 744 33 23
Email	mathilde.dekeukeleire@uclouvain.be
Website	https://uclouvain.be
"ROR"	https://ror.org/02495e989

Funders

Funder type

Government

Fédération Wallonie-Bruxelles
Government organisation / Local government

Alternative name(s): French Community of Belgium, Federation Wallonia-Brussels, Communauté Française de Belgique
Location: Belgium

Results and Publications

Intention to publish date	01/10/2022
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The results of the PCR, AVIOQ and questionnaires will be published in three publications. Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	Consent was obtained from each participant. The data is kept for 20 years. All data was coded with a unique number containing no personally identifiable information. A sequential identification number was automatically allocated to each participant enrolled in the study. This number identified the participant and is composed of 12 digits: a two-digit number allocated to the school he/she is attending; a two-digit number allocated to the class, with a first digit for the grade, or 9 for adults and a second digit numbering classes within each grade; a two-digit serial number within the class he/she is in; a two-digit control number (such as modulo 89 of the 8 first digits); a two-digit number corresponding to the calendar week of data collection. Data will be shared after approval by the ethics committee. They are available upon request to Annie Robert (annie.robert@uclouvain.be).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Children		12/04/2022	No	Yes
Participant information sheet	Parents		12/04/2022	No	Yes
Participant information sheet	School attenders		12/04/2022	No	Yes
Results article		06/10/2022	17/10/2022	Yes	No
Results article		30/06/2023	03/11/2023	Yes	No
Results article		04/09/2023	03/11/2023	Yes	No

Additional files

41519_PIS_Children.pdf: Children
41519_PIS_Parents.pdf: Parents
41519_PIS_SchoolAttenders.pdf: School attenders

Editorial Notes

27/01/2025: The overall study end date was changed from 14/01/2025 to 31/05/2025.
03/11/2023: Publication references added.
17/10/2022: Publication reference added.
12/04/2022: Trial's existence confirmed by the Hospital-Faculty Ethics Committee Saint-Luc - UCLouvain.