NCT05396040

School Studies Within the EuCARE Horizon Europe Research Project (EuCARE-SCHOOLS)

School Studies Within the EuCARE Horizon Europe Research Project (EUCARE-SCHOOLS Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,373 (actual)
• Sponsor: Euresist Network GEIE · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

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.

Conditions

• STUDENTS

Interventions

Type	Name	Description
PROCEDURE	LOLLI METHODE	WEEKLY SCREENING WITH POOLED SALIVA PCR TEST

Timeline

• Start date: 2022-05-10
• Primary completion: 2024-06-30
• Completion: 2024-08-01
• First posted: 2022-05-27
• Last updated: 2025-02-25

Locations

5 sites across 3 countries: Italy, Mexico, Portugal