Periodic Reporting for period 1 - EuCARE (European Cohorts of Patients and Schools to Advance Response to Epidemics)
Reporting period: 2021-10-14 to 2022-10-13
The EuCARE project (European Cohorts of Patients and Schools to Advance Response to Epidemics) aims at unveiling the impact of SARS-CoV-2 variants on key sectors of public health. To this end, it gathers a comprehensive multidisciplinary team of clinicians, virologists, epidemiologists, statisticians and top experts in artificial intelligence from strategic areas across 4 continents.
The four project’s cohorts - Hospitalised patients, Post Acute Sequelae of Sars-Cov-2 infection (PASC) patients and Health Care Workers (HCW) and Schools - are the basis of several different observational studies.
The project’s objectives include:
1. to study viral variants in relation to their capacity to escape control by available vaccines
2. to study viral variants in relation to their capacity to escape diagnosis by available tests
3. to study the host immune response to different variants, in terms of both antibody and cellular immunity; and to evaluate possible cross-immunisation with other coronaviruses
4. to assess the role of the different viral variants in response to treatment interventions and in disease progression, including long-term outcome, and to identify predictors of patients at higher risk
5. to determine the prevalence of viral variants, their attack rates and clusters in schools compared with the general population
6. to compare the efficacy of different screening methods and of different preventive measures in schools with respect to new viral variants; in particular, to evaluate an emerging pooled saliva screening method: the Lolli methode
7. to evaluate the psychological and learning-loss effect of the containment measures in school during the pandemic.
To deal with complex interactions among many variables, including large dimensional parameters, EuCARE will harness the power of artificial intelligence.
In the longer-term, EuCARE is committed to maintain active cooperation beyond the duration of the project with a dedicated task in the project. The project IT and ethics infrastructure and the harmonised research procedures make the cohort and laboratory network rapidly available to tackle newly emerging infectious diseases, thus contributing to pandemic preparedness on a global scale.
The four project’s cohorts - Hospitalised patients, Post Acute Sequelae of Sars-Cov-2 infection (PASC) patients and Health Care Workers (HCW) and Schools - are the basis of several different observational studies.
The project’s objectives include:
1. to study viral variants in relation to their capacity to escape control by available vaccines
2. to study viral variants in relation to their capacity to escape diagnosis by available tests
3. to study the host immune response to different variants, in terms of both antibody and cellular immunity; and to evaluate possible cross-immunisation with other coronaviruses
4. to assess the role of the different viral variants in response to treatment interventions and in disease progression, including long-term outcome, and to identify predictors of patients at higher risk
5. to determine the prevalence of viral variants, their attack rates and clusters in schools compared with the general population
6. to compare the efficacy of different screening methods and of different preventive measures in schools with respect to new viral variants; in particular, to evaluate an emerging pooled saliva screening method: the Lolli methode
7. to evaluate the psychological and learning-loss effect of the containment measures in school during the pandemic.
To deal with complex interactions among many variables, including large dimensional parameters, EuCARE will harness the power of artificial intelligence.
In the longer-term, EuCARE is committed to maintain active cooperation beyond the duration of the project with a dedicated task in the project. The project IT and ethics infrastructure and the harmonised research procedures make the cohort and laboratory network rapidly available to tackle newly emerging infectious diseases, thus contributing to pandemic preparedness on a global scale.
The legal, ethical and IT infrastructure of the project has been set up.
The protocols of all the cohort studies have been written, received the needed ethical approvals and have been published on Clinicaltrials.gov.
The Data Management Board defined the EuCARE Data management Policy.
The Integrated Suite for data collection has been developed in accordance with and harmonising all the study protocols. It includes:
● the EuCARE centralised, normalised database, collecting the data from all the cohorts and all the contributing centres
● the online data entry interface (CRFs) with automated data checks
● the Template for data transfer by secure file upload
● a mobile interface for questionnaires
● the system's standard operating procedures.
It will allow harmonisation of data with the emerging standards and the other cohort initiatives in the field.
The laboratory network activities are ongoing: the EuCARE IMMUNITY study protocol for the vaccine efficacy analysis has been realised and shared with the other projects in the Cohort Coordination Board.
Assessment of the diagnostic systems present in the projects’ laboratories for their ability to recognize different SARS-COV-2 variants is ongoing.
A decentralised library of live virus variants has been established which is constantly updated to reflect the dynamic circulation of SARS-CoV-2 lineages.
The hospitalized patients cohort, the post-covid cohort and the healthcare workers cohort almost finalized the retrospective data collection and started the prospective patients’ involvement.
The schools cohort studies, both the observational study and the inteventional Lolli study, are ongoing in Italy, Portugal and Mexico. In spring 2022 a pilot phase in 3 schools in Italy demonstrated the acceptability and the feasibility of the study as well as some needed improvements that have been implemented.
The artificial intelligence teams aligned their data definitions with all the study protocols and identified and collected the external datasets of possible confounders to be considered in the cohort studies.
The project website and the other projects’ social media have been setup. The project has been presented in several meetings and appeared in numerous large audience newspapers, TV news and radio broadcasts. 14 scientific papers have been published in international peer reviewd journals.
The protocols of all the cohort studies have been written, received the needed ethical approvals and have been published on Clinicaltrials.gov.
The Data Management Board defined the EuCARE Data management Policy.
The Integrated Suite for data collection has been developed in accordance with and harmonising all the study protocols. It includes:
● the EuCARE centralised, normalised database, collecting the data from all the cohorts and all the contributing centres
● the online data entry interface (CRFs) with automated data checks
● the Template for data transfer by secure file upload
● a mobile interface for questionnaires
● the system's standard operating procedures.
It will allow harmonisation of data with the emerging standards and the other cohort initiatives in the field.
The laboratory network activities are ongoing: the EuCARE IMMUNITY study protocol for the vaccine efficacy analysis has been realised and shared with the other projects in the Cohort Coordination Board.
Assessment of the diagnostic systems present in the projects’ laboratories for their ability to recognize different SARS-COV-2 variants is ongoing.
A decentralised library of live virus variants has been established which is constantly updated to reflect the dynamic circulation of SARS-CoV-2 lineages.
The hospitalized patients cohort, the post-covid cohort and the healthcare workers cohort almost finalized the retrospective data collection and started the prospective patients’ involvement.
The schools cohort studies, both the observational study and the inteventional Lolli study, are ongoing in Italy, Portugal and Mexico. In spring 2022 a pilot phase in 3 schools in Italy demonstrated the acceptability and the feasibility of the study as well as some needed improvements that have been implemented.
The artificial intelligence teams aligned their data definitions with all the study protocols and identified and collected the external datasets of possible confounders to be considered in the cohort studies.
The project website and the other projects’ social media have been setup. The project has been presented in several meetings and appeared in numerous large audience newspapers, TV news and radio broadcasts. 14 scientific papers have been published in international peer reviewd journals.
EuCARE has the ambition to deliver ground-breaking results as well as to pilot and deliver achievable solutions and protocols already in the short and medium term.
● The assessment of the impact of variants on the accuracy of diagnostic testing and on the efficacy of the different vaccines can inform the selection of the appropriate diagnostic procedures and vaccines.
● The availability of samples from people vaccinated with a wide variety of vaccines and the possibility to detect new variants of concern as they emerge from routine diagnostics will allow for timely updates of these results.
● The study of the immune response to different viral variants following natural infection, either with or without subsequent vaccination, is fundamental to defining what infections or combinations of infection and vaccination are protective towards the largest set of variants.
● The study of the effect of viral variants on disease progression and on post acute sequelae of COVID-19 will provide much awaited novel results, made possible in the project by the use of machine learning and other advanced artificial intelligence techniques on large amounts of data also from publicly available sources.
● The studies on the spread of infection in schools will provide novel results in relation to variants. The role of screening methods, containment protocols and DPIs in schools, complemented by the analysis of mobility, socio-cultural and psychological issues, is highly innovative and with immediate impactful application. The analysis of learning loss in relation to all the previous variables is highly innovative.
● Together with the extensive evaluation in diverse school settings of the already tested pooled saliva screening method, the schools studies will provide highly awaited and affordable models to support the school system in the pandemics.
● The assessment of the impact of variants on the accuracy of diagnostic testing and on the efficacy of the different vaccines can inform the selection of the appropriate diagnostic procedures and vaccines.
● The availability of samples from people vaccinated with a wide variety of vaccines and the possibility to detect new variants of concern as they emerge from routine diagnostics will allow for timely updates of these results.
● The study of the immune response to different viral variants following natural infection, either with or without subsequent vaccination, is fundamental to defining what infections or combinations of infection and vaccination are protective towards the largest set of variants.
● The study of the effect of viral variants on disease progression and on post acute sequelae of COVID-19 will provide much awaited novel results, made possible in the project by the use of machine learning and other advanced artificial intelligence techniques on large amounts of data also from publicly available sources.
● The studies on the spread of infection in schools will provide novel results in relation to variants. The role of screening methods, containment protocols and DPIs in schools, complemented by the analysis of mobility, socio-cultural and psychological issues, is highly innovative and with immediate impactful application. The analysis of learning loss in relation to all the previous variables is highly innovative.
● Together with the extensive evaluation in diverse school settings of the already tested pooled saliva screening method, the schools studies will provide highly awaited and affordable models to support the school system in the pandemics.