Clinical trial NCT05396040: School Studies Within the EuCARE Horizon Europe Research Project (EuCARE-SCHOOLS)
Official title: School Studies Within the EuCARE Horizon Europe Research Project (EUCARE-SCHOOLS Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: STUDENTS
Lead sponsor: Euresist Network GEIE
Sponsor class: OTHER
Collaborators: name: University of Salento
name: Istituto Europeo di Oncologia
name: University of Milan
name: University of Lisbon
name: University of Cologne
name: Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"
First posted: 2022-05-27
Enrollment: 3373
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will enrol 440 classes (around 8800 students, teachers and other personnel) from 2 countries, randomised to Lolli-Methode or SoC. Samples from pools will be regularly collected and tested using PCR-based techniques.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this clinical trial, the aim is to determine if regular screening with pooled saliva tests (Lolli-Method) is useful to support school opening and to reduce clusters and attack rates in schools, compared with the standard of care (SoC) regular surveillance based on symptoms and contact tracing by public health departments.

Detailed description: In this clinical trial, it will be determined if regular screening with pooled saliva tests (Lolli-Method) is useful to support school opening and to reduce clusters and attack rates in schools, compared with the standard of care (SoC) regular surveillance based on symptoms and contact tracing by public health departments. A multicenter cluster randomised interventional study will be set-up to evaluate the efficacy and applicability of the Lolli-Methode. The study will enrol 440 classes (around 8800 students, teachers and other personnel) from 2 countries, randomised to Lolli-Methode or SoC. Samples from pools will be regularly collected and tested using PCR-based techniques. Test results will be combined with questionnaires filled in by children, parents and schools teachers and principals, concerning social distancing measures implemented and psychological impact of the preventive measures applied during the pandemic. A thorough data analysis will then be performed to understand the applicability of Lolli-Methode to reduce SARS-COV-2 transmission in schools, including incidence, attack rates and cluster analysis. On the other hand, mobility changes and psychological outcomes will be analysed and compared with variables related to SARS-COV-2 transmission. By the end of this study, it will be identified and characterised the applicability of the Lolli-Methode for SARS-COV-2 surveillance, as well as the impact of pandemic preventive measures on children.

An ancillary observational study will be carried out on a different population of schools to study the prevalence of SARS-COV-2, frequencies and size of clusters and attack rates in schools, compared with those of previous waves; to compare the effectiveness of different preventive measures adopted in different schools; to investigate psychological issues in students and teachers related to the pandemic's containment measures.

Eligibility criteria: Inclusion Criteria:

* Kindergartens and school-age children from public or private schools .
* Enrolled children may be students of classes that have expressed their consent to participate
* School personnel of participating schools
* Householders of participating children
* Informed consent (for minors the informed consent will be signed by parents or legal guardians) .
* For minors: will to participate.

Exclusion Criteria:

* No informed consent by schools or children, or the adult participant
* Suspicion of acute COVID-19 infection:

In case of unknown respiratory infection, no presence of symptoms for at least 48 hours. In case of confirmed SARS-COV-2 infection: inclusion at the earliest 21 days from PCR-positive diagnosis after the onset of potential symptoms and no presence of symptoms for at least 48 hours (according to Standard of Care).

Primary outcomes:
measure: Frequencies of clusters
timeFrame: up to 18 months
measure: Number of participating classes
timeFrame: up to 18 months
Secondary outcomes:
measure: Transmission/prevalence of SARS-COV-2 in schools by variants
timeFrame: up to 18 months
measure: Psychological status of children
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IEO Istituto Europeo di Oncologia Research Hospital and Treatment Centre
state: Lombardia
city: Milan
country: Italy
facility: Università statale di Milano, Dipartimento di Scienze Biomediche e Cliniche L. Sacco
state: Lombardia
city: Lecce
country: Italy
facility: DISTEBA, Università del Salento
state: Puglia
city: Villahermosa
country: Mexico
facility: Hospital Regional de Alta Especialidad Dr. Juan Graham Casasus
state: Tabasco
city: Lisbon
country: Portugal
facility: Global Health and Tropical Medicine; Instituto de Higiene e Medicina Tropical, Universidade Nova de Lisboa (UNL)
Study officials:
affiliation: EURESISTE NETWORK GEIE
name: FRANCESCA INCARDONA
role: STUDY_CHAIR
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