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

STUDENTS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396040
• Other study ID #: EuCARE-SCHOOLS
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Euresist Network GEIE
• Contact: FRANCESCA INCARDONA
• Phone: +393356112830
• Email: francesca.incardona[@]euresist.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8800
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• STUDENTS

Intervention

Procedure:
• LOLLI METHODE
WEEKLY SCREENING WITH POOLED SALIVA PCR TEST

Locations

Country	Name	City	State
Italy	DISTEBA, Università del Salento	Lecce	Puglia
Italy	IEO Istituto Europeo di Oncologia Research Hospital and Treatment Centre	Milan	Lombardia
Italy	Università statale di Milano, Dipartimento di Scienze Biomediche e Cliniche L. Sacco	Milan	Lombardia
Mexico	Hospital Regional de Alta Especialidad Dr. Juan Graham Casasus	Villahermosa	Tabasco
Portugal	Global Health and Tropical Medicine; Instituto de Higiene e Medicina Tropical, Universidade Nova de Lisboa (UNL)	Lisbon

Sponsors (7)

Lead Sponsor	Collaborator
Euresist Network GEIE	Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus", Istituto Europeo di Oncologia, University of Cologne, University of Lisbon, University of Milan, University of Salento

Countries where clinical trial is conducted

Italy,  Mexico,  Portugal, 

References & Publications (4)

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. 2021 Jul 2:2021.04.09.21255206. doi: 10.1101/2021.04.09.21255206. Preprint. — View Citation

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. Erratum In: Mol Cell. 2020 Dec 17;80(6):1136-1138. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Transmission/prevalence of SARS-COV-2 in schools by variants	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
Secondary	Psychological status of children	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

External 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
•   Tönshoff et al, Prevalence of SARS-COV-2 Infection in Children and Their Parents in Southwest Germany. Burkhard Tönshoff et al, Jamapediatrics January 22, 2021
•   Zhu Yanshan, Bloxham Conor J et al.