STUDENTSNCT05396040
School Studies Within the EuCARE Horizon Europe Research Project (EuCARE-SCHOOLS)
A study testing LOLLI METHODE in people with STUDENTS, run by Euresist Network GEIE at 5 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- STUDENTS
- What is being tested?
- LOLLI METHODE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,373 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 10 May 2022to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Italy3 sites
DISTEBA, Università del Salento
Lecce, Apulia, 73100
IEO Istituto Europeo di Oncologia Research Hospital and Treatment Centre
Milan, Lombardy, 20141
Università statale di Milano, Dipartimento di Scienze Biomediche e Cliniche L. Sacco
Milan, Lombardy, 20154
Mexico1 site
Hospital Regional de Alta Especialidad Dr. Juan Graham Casasus
Villahermosa, Tabasco, 86126
Portugal1 site
Global Health and Tropical Medicine; Instituto de Higiene e Medicina Tropical, Universidade Nova de Lisboa (UNL)
Lisbon, Lisbon District, 1349-008
About this study
Official title: 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.
Read the 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
- Being tested
- LOLLI METHODE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOLLI METHODEProcedure or surgery
WEEKLY SCREENING WITH POOLED SALIVA PCR TEST
| Study group | Role | What they receive |
|---|---|---|
| LOLLI METHODE | Experimental | regular screening with pooled saliva tests (Lolli-Method) Receives: Procedure: LOLLI METHODE |
| STANDARD OF CARE | No intervention | STANDARD OF CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: up to 18 months
Secondary outcomes (2)
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)
Measured: up to 18 months
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.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start10 May 2022
- Primary completion30 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for STUDENTSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 3,373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Euresist Network GEIE
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salento, Istituto Europeo di Oncologia, University of Milan, University of Lisbon, University of Cologne, Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"
- Responsible party
- Sponsor
- Investigators
- FRANCESCA INCARDONA, Study chair, EURESISTE NETWORK GEIE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396040
- Sponsor's protocol ID
- EuCARE-SCHOOLS
- Status last verified
- Aug 2024
- First submitted
- 18 May 2022
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 33880483Robson 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.
PubMed 32853546Sekine 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.
PubMed 32979941Singh 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.
PubMed 33803400Raimondi 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.
PubMed 36597074
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Studies Within the EuCARE Horizon Europe Research Project (EUCARE-SCHOOLS Study)
- ClinicalTrials.gov ID
- NCT05396040
- Acronym / sponsor ID
- EuCARE-SCHOOLS
- Conditions
- STUDENTS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,373 participants (actual)
- Lead sponsor
- Euresist Network GEIEUniversity, hospital or other
- Collaborators
- University of Salento, Istituto Europeo di Oncologia, University of Milan, University of Lisbon, University of Cologne, Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus"
- Study start
- 10 May 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| LOLLI METHODE | Experimental | Procedure: LOLLI METHODEregular screening with pooled saliva tests (Lolli-Method) |
| STANDARD OF CARE | No intervention | –STANDARD OF CARE |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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) .
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LOLLI METHODEWEEKLY SCREENING WITH POOLED SALIVA PCR TEST | Procedure or surgery | LOLLI METHODE |
Primary outcome
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.
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
2 secondary outcomes
Transmission/prevalence of SARS-COV-2 in schools by variants
Time frame: up to 18 months
Psychological status of children
Time frame: up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 33880483Ozer 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.
- Background: PubMed 32853546Robson 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.
- Background: PubMed 32979941Sekine 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.
- Background: PubMed 33803400Singh 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.
- Derived from this study: PubMed 36597074Raimondi 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.
- Otte im Kampe et al, Surveillance of COVID-19 school outbreaks, Germany, March to August 2020, Eveline Otte im Kampe et al., Eurosurveillance, Sept 2020Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FRANCESCA INCARDONA study chair
EURESISTE NETWORK GEIE
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LOLLI METHODE in people with STUDENTS, run by Euresist Network GEIE at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Mexico, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequencies of clusters (time frame: up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05396040, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.