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

NCT05396040 | Completed

• 1 other identifier: EuCARE-SCHOOLS
• Study Type: interventional
• Target: 3,373
• Locations: 3 countries
• Sites: 5

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.

Conditions

STUDENTS

Outcome Measures

Primary Outcomes (2)

• Frequencies of clusters

  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

  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 Outcomes (2)

• Transmission/prevalence of SARS-COV-2 in schools by variants

  up to 18 months

• Psychological status of children

  up to 18 months

Study Arms (2)

LOLLI METHODE

EXPERIMENTAL

regular screening with pooled saliva tests (Lolli-Method)

Procedure: LOLLI METHODE

STANDARD OF CARE

NO INTERVENTION

STANDARD OF CARE

Interventions

LOLLI METHODE PROCEDURE

WEEKLY SCREENING WITH POOLED SALIVA PCR TEST

LOLLI METHODE

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Euresist Network GEIE: lead
• University of Salento: collaborator
• Istituto Europeo di Oncologia: collaborator
• University of Milan: collaborator
• University of Lisbon: collaborator
• University of Cologne: collaborator
• Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus": collaborator

Study Sites (5)

DISTEBA, Università del Salento

Lecce, Apulia, 73100, Italy

Location

IEO Istituto Europeo di Oncologia Research Hospital and Treatment Centre

Milan, Lombardy, 20141, Italy

Location

Università statale di Milano, Dipartimento di Scienze Biomediche e Cliniche L. Sacco

Milan, Lombardy, 20154, Italy

Location

Hospital Regional de Alta Especialidad Dr. Juan Graham Casasus

Villahermosa, Tabasco, 86126, Mexico

Location

Global Health and Tropical Medicine; Instituto de Higiene e Medicina Tropical, Universidade Nova de Lisboa (UNL)

Lisbon, Lisbon District, 1349-008, Portugal

Location

Related Publications (5)

• Ozer EA, Simons LM, Adewumi OM, Fowotade AA, Omoruyi EC, Adeniji JA, Dean TJ, Zayas J, Bhimalli PP, Ash MK, Godzik A, Schneider JR, Mamede JI, Taiwo BO, Hultquist JF, Lorenzo-Redondo R. Coincident rapid expansion of two SARS-CoV-2 lineages with enhanced infectivity in Nigeria. medRxiv [Preprint]. 2021 Jul 2:2021.04.09.21255206. doi: 10.1101/2021.04.09.21255206.

  PMID: 33880483 BACKGROUND

• Robson F, Khan KS, Le TK, Paris C, Demirbag S, Barfuss P, Rocchi P, Ng WL. Coronavirus RNA Proofreading: Molecular Basis and Therapeutic Targeting. Mol Cell. 2020 Sep 3;79(5):710-727. doi: 10.1016/j.molcel.2020.07.027. Epub 2020 Aug 4.

  PMID: 32853546 BACKGROUND

• Sekine T, Perez-Potti A, Rivera-Ballesteros O, Stralin K, Gorin JB, Olsson A, Llewellyn-Lacey S, Kamal H, Bogdanovic G, Muschiol S, Wullimann DJ, Kammann T, Emgard J, Parrot T, Folkesson E; Karolinska COVID-19 Study Group; Rooyackers O, Eriksson LI, Henter JI, Sonnerborg A, Allander T, Albert J, Nielsen M, Klingstrom J, Gredmark-Russ S, Bjorkstrom NK, Sandberg JK, Price DA, Ljunggren HG, Aleman S, Buggert M. Robust T Cell Immunity in Convalescent Individuals with Asymptomatic or Mild COVID-19. Cell. 2020 Oct 1;183(1):158-168.e14. doi: 10.1016/j.cell.2020.08.017. Epub 2020 Aug 14.

  PMID: 32979941 BACKGROUND

• Singh J, Samal J, Kumar V, Sharma J, Agrawal U, Ehtesham NZ, Sundar D, Rahman SA, Hira S, Hasnain SE. Structure-Function Analyses of New SARS-CoV-2 Variants B.1.1.7, B.1.351 and B.1.1.28.1: Clinical, Diagnostic, Therapeutic and Public Health Implications. Viruses. 2021 Mar 9;13(3):439. doi: 10.3390/v13030439.

  PMID: 33803400 BACKGROUND

• Raimondi S, Gandini S, Rubio Quintanares GH, Abecasis A, Lopalco PL, D'Ecclesiis O, Chiocca S, Tomezzoli E, Cutica I, Mazzoni D, Amparo N, Pingarilho M, Carmagnola D, Dellavia C, Zuccotti G, Ronchini C, Bellerba F, Dewald F, Kaiser R, Incardona F; Eucare WP4. European Cohorts of patients and schools to Advance Response to Epidemics (EuCARE): a cluster randomised interventional and observational study protocol to investigate the relationship between schools and SARS-CoV-2 infection. BMC Infect Dis. 2023 Jan 3;23(1):1. doi: 10.1186/s12879-022-07947-6.

  PMID: 36597074 DERIVED

Related Links

• Otte im Kampe et al, Surveillance of COVID-19 school outbreaks, Germany, March to August 2020, Eveline Otte im Kampe et al., Eurosurveillance, Sept 2020

Study Officials

• FRANCESCA INCARDONA

  EURESISTE NETWORK GEIE

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 27, 2022
• Study Start: May 10, 2022
• Primary Completion: June 30, 2024
• Study Completion: August 1, 2024
• Last Updated: February 25, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after the Study end no time limit was fixed
• Access Criteria: request to the study coordinator or to he project partners

Locations

PT (1); IT (3); ME (1)