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

September 6, 2023 updated by: Euresist Network GEIE

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

8800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Lombardia
      • Milan, Lombardia, Italy, 20141
        • Recruiting
        • IEO Istituto Europeo di Oncologia Research Hospital and Treatment Centre
        • Contact:
      • Milan, Lombardia, Italy, 20154
        • Recruiting
        • Università statale di Milano, Dipartimento di Scienze Biomediche e Cliniche L. Sacco
        • Contact:
    • Puglia
      • Lecce, Puglia, Italy, 73100
        • Recruiting
        • DISTEBA, Università del Salento
        • Contact:
  • Mexico
    • Tabasco
      • Villahermosa, Tabasco, Mexico, 86126
        • Recruiting
        • Hospital Regional de Alta Especialidad Dr. Juan Graham Casasus
        • Contact:
        • Principal Investigator:
          • GIBRAN RUBIO QUINTANARES, DR
  • Portugal
      • Lisbon, Portugal, 1349-008
        • Not yet recruiting
        • Global Health and Tropical Medicine; Instituto de Higiene e Medicina Tropical, Universidade Nova de Lisboa (UNL)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LOLLI METHODE
regular screening with pooled saliva tests (Lolli-Method)
Procedure: LOLLI METHODE
WEEKLY SCREENING WITH POOLED SALIVA PCR TEST
No Intervention: STANDARD OF CARE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequencies of clusters
Time Frame: up to 18 months
Frequencies of clusters in classrooms in which pooled saliva tests (Lolli-Method) are performed in association with standard contact-tracing protocols, compared with classrooms in which SoC protocols are applied.
up to 18 months
Number of participating classes
Time Frame: up to 18 months
Number of classes and of students in the classes that accept to participate in the Lolli-Methode study, if asked, during time
up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transmission/prevalence of SARS-COV-2 in schools by variants
Time Frame: up to 18 months
Transmission/prevalence of SARS-COV-2 in schools by variants, by assessing the proportion of students/staff with positive SARS-COV-2 test identified by pooled saliva tests (Lolli-Method)
up to 18 months
Psychological status of children
Time Frame: up to 18 months
Psychological status of children during coronavirus pandemics: negative and positive feeling during confinement, worries and expectations about school resumption as evaluated by questionnaires.
up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Euresist Network GEIE

Collaborators

University of Cologne
University of Milan
University of Lisbon
Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"
University of Salento
Istituto Europeo di Oncologia

Investigators

  • Study Chair: FRANCESCA INCARDONA, EURESISTE NETWORK GEIE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

May 23, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • EuCARE-SCHOOLS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study is part of a project funded by the European Commission and the project agreement with the Commission affirms that the data and the results will be public

IPD Sharing Time Frame

after the Study end no time limit was fixed

IPD Sharing Access Criteria

request to the study coordinator or to he project partners

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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