Pan-European COVID-19 cohorts

The COVID-19 pandemic created an urgent demand for evidence-based innovative and rapid solutions to deal with health and health-related emergencies, to offer the best possible care to patients, and to protect the general population and the frontline health care staff. This expression of interest is to complement research efforts in the fight against the coronavirus, in particular projects resulting from the first H2020 expression of interest, which is currently addressing epidemiology and modelling, diagnostics, treatment, and vaccine. In parallel, Research and Innovation should without delay start analysing the lessons from the present crisis, in particular its impact on health and socio-economic aspects, and propose recommendations for being better prepared in the future if confronted with similar events.

Proposals submitted under this expression of interest are expected to establish new and/or build on existing large-scale cohorts to rapidly advance the knowledge on the control of the SARS-CoV-2 infection, develop evidence-based recommendations for effective prevention of the spreading, protection of the population in the coming months/years, and optimized treatment of the COVID-19 patients. The population-based cohorts should also inform on longer-term consequences of COVID-19 on health and well-being of individuals.

The population-based COVID-19 cohort should include non-infected and infected individuals. The cohort should be large enough to provide valid and reliable evidence and robust recommendations, and be suitable for the conduct of retrospective and prospective studies. The cohort should include both sexes, all ages, all conditions (healthy, pregnant, physical or mental disabilities, chronic disorders, infectious diseases, etc.), all clinical outcomes (from no symptom to mortality), as well as a large spectrum of different clinical management practices and treatments. The inclusion of individuals who are SARS-CoV-2-negative should enable a prospective follow up and an analysis of vaccination response when vaccines will be available.

The following aspects should be considered:

• The population-based cohort should allow to rapidly identify what risk and protective factors influence the susceptibility to infection, clinical manifestation (asymptomatic, mild, severe, lethal), therapeutic response and clinical outcome in order to deliver evidence-based recommendations on the best strategies to control the spread of the virus and to protect the entire population. Essential factors to be considered might include the following: sex, age, genetics, viral variants, virus shedding, host-pathogen interactions, immune system, medication, previous vaccinations, deep phenotyping, microbiome, biomarkers, co-morbidities, co-infections, clinical events including clinical course of the COVID-19 infection, etc. Other variables could also be informative, such as environment, biodiversity, pollution, urban characteristics, climate, socio-economic determinants, disinformation, lifestyle, confinement measures, etc.
• The population-based cohort should allow to identify the most successful clinical management options and treatments since the start of the outbreak, from primary infection up to post-recovery multidisciplinary rehabilitation. The cohort should take stock of the evidence produced by large-scale studies and/or local practices in order to develop recommendations for optimized treatment and management of future patients.
• The population-based cohort should also assess in the short/medium/long-term the impact of COVID-19 and the varying mitigating national/regional measures on health, well-being and socio-economic factors of individuals. Issues to be considered might include the following: disruption of medical care, especially for chronic diseases (cancer, metabolic syndrome, CVD/Hypertension, etc.), mental health, employment, education, social interactions, etc.

The cohort should cover a wide geographical area in Europe and other parts of the world. Interaction with national and/or European biobanks could be of high relevance. Special attention should be given to harmonisation of data collection and standardisation of protocols, as well as to the adoption of common formats and models. Linking with data from electronic health records, disease registries and health insurance data could also be of high relevance. Where appropriate and likely to increase research impact, cloud-based collaborative portal, artificial intelligence and any other available ICT tool should be integrated[[Where relevant, proposals should consider the close collaboration with leading European supercomputing centres to use high-end computing, data and simulation resources in order to accelerate findings. In this respect, the Supercomputing facilities in Barcelona (BSC) and Bologna (Cineca) are open to collaborate with any interested proposer or successful proposal. Other leading European supercomputer centres, such as the organisations hosting the PRACE Tier-0 supercomputers, may also be interested in such collaborations]]. Special attention should also be given to links with the newly established European COVID-19 research data sharing platform[[https://www.covid19dataportal.org/]].

Collaboration is strongly encouraged with Members States of the European Union and Associated Countries to deliver results that are representative of the whole region. Worldwide international collaboration is strongly encouraged.

The cohort should liaise with the coordinated and support action on cohorts, which will be funded through this expression of interest, and large COVID-19 clinical trials. Collaboration among successful proposals and with the existing network of H2020 COVID-19 projects will be encouraged.

The Commission considers that proposals requesting a contribution from the EU of between EUR 15-20 million would allow these specific challenges to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

• In the short-term, to provide robust evidence on the best strategies for the control the SARS-CoV-2 spread and the protection of the population, as well as the optimized clinical management and treatment of COVID-19 patients.
• In the medium/long-term, to evaluate the impact of vaccination and provide robust evidence on best vaccine options and strategies.
• In the short/long-term, to assess the impact of COVID-19 on health and its effects on socio-economic features of individuals and propose recommendations for the optimal management of future outbreak.