NCT05046470

Brief Summary

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 incidence level in schools is mainly a consequence of community transmission. The incidence level in household and that the secondary attack rate in schools remains at least 5 times lower that the transmission level in households.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,233

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2025

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

September 7, 2021

Last Update Submit

May 7, 2024

Conditions

Keywords

Primary Schools

Outcome Measures

Primary Outcomes (4)

  • Infection of a child with SARS-CoV-2 secondary to a classmate

    Time varying number and proportion of children infected with SARS-CoV-2 secondary to an asymptomatic infected classmate (transmission rate inside school with the child being the infector).

    6 weeks

  • Infection of an adult school-attender with SARS-CoV-2 secondary to an infected child

    Time varying number and proportion of adult school-attenders infected with SARS-CoV-2 secondary to an asymptomatic infected child (transmission rate inside school but from a child to an adult).

    6 weeks

  • Infection of a child with SARS-CoV-2 secondary to an adult school attender

    Time varying number and proportion of children infected with SARS-CoV-2 secondary to an infected adult school-attender (transmission rate inside school but from an adult to a child)

    6 weeks

  • Infection of a child with SARS-CoV-2 secondary to a contact outside the school, including the household

    Time varying number and proportion of children infected with SARS-CoV-2 secondary to a household contact or outside the school (transmission rate from in community).

    6 weeks

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All Belgian primary schools of the Federation Wallonia - Brussels that have organized a full resumption of school activities with the control measures recommended by the government, are eligible for the study. Twelve schools were chosen by purposive criteria: either high (≥2 classes per grade) or low size of the school, a school within an area with either a high or a low incidence of SARS-CoV-2 during April 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 idex \>14 or \<6).

You may qualify if:

  • All children and school attenders from selected schools was invited to participate

You may not qualify if:

  • Refusal to provide written informed consent before enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLouvain

Brussels, 1200, Belgium

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Annie Robert, Pr

    Université Catholique de Louvain

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2021

First Posted

September 16, 2021

Study Start

January 14, 2021

Primary Completion

January 14, 2023

Study Completion

January 14, 2025

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

All collected IPD

Locations