Finding the threshold value in antibody assay after SARS-CoV-2 breakthrough infection in fully vaccinated healthcare workers Knowing the trend of the antibody level in the human blood to SARS-CoV-2 is particularly significant in understanding the immune response against the virus. The ORCHESTRA study “Usefulness and Limitations of Anti-S IgG Assay in Detecting Previous SARS-CoV-2 Breakthrough Infection in Fully Vaccinated Healthcare Workers” investigated if the anti-S IgG assay can be used as indicator for previous SARS-CoV-2 infection.  Gianluca Spiteri and Maria Grazia Lourdes Monaco, occupational physicians of Occupational Medicine Unit at the University Hospital of Verona, are first authors of the study and explain what the team - associated with ORCHESTRA Work Package 5 (WP5 – the Healthcare Workers Cohort) – researched.

This publication has been performed by Work Package 2. This publication was produced by Work Package 2. The responses were given by Maria Giulia Caponcello, Clinical Research Associate, Servicio Andaluz de Salud, SAS.

The “ORCHESTRA Core Data elements for COVID-19" (OcDeC), which is a core data set of standardised variables for use and future use with the goal to simplify the merging of data and to increase metadata quality, is the result of the joint efforts undertaken by the ORCHESTRA team lead by BIH_Charité Home - Berlin Institute of Health at Charité (bihealth.org).The "Development of OcDeC within ORCHESTRA" has now been shortlisted for the Interoperability Award 2022: Interoperability Award 2022 - X-eHealth. The Interoperability Award is part of the European Union project X-eHealth (X-eHealth - Exchanging Electronic Health Records) that aims to bring forward e-Health in Europe for an international benefit. After the evaluation by an international jury, and out of a total of 19 applications from 10 countries (Austria, Belgium, Cyprus, Denmark, France, Germany, Netherlands, Portugal, Slovenia and Switzerland), 13 projects were chosen to be candidates fort the award. All 13 projects have achieved significant work in the field of health digitalisation.

The ORCHESTRA podcast is intended to contribute to highlighting different aspects in research. Each podcast will have different guests from different professional backgrounds, each sharing experience, learnings and knowledge from their specific perspective. Episode 1 gives an overview of ORCHESTRA - with a quick run through the different work packages - and its mission . Prof. Evelina Tacconelli, head of ORCHESTRA, talks about benefits, challenges and how her team from the University of Verona convinced her to apply for the E.U. Horizon2020 research project on COVID-19 - which has become ORCHESTRA: a multidisciplinary European and international research infrastructure sharing tasks, expertise and efforts for the benefit of COVID-19 patients.

The study examined the most determining causes for exhaustion of frontline and second line healthcare workers (HCW) during the third wave of the COVID-19 pandemic. Responsible ORCHESTRA partner is the National Institute of Public Health (INSP) in Bucharest which contributes to Work Package 5, the Healthcare Workers Cohort. Prof. Marina Otelea, is one of the authors and explains results and impact.

We are hiring!

If you are a research enthusiast, you are welcome to contribute your talents and expertise in ORCHESTRA. We are looking for Medical Doctor or Clinical Researcher and Clinical Research Associate.

1. Medical Doctor or Clinical Researcher
You will be responsible for: • Development of research protocols and standard operating procedures (SOPs) as planned for the ORCHESTRA project in its role as coordinator • Ensuring adherence of protocols with national and European ethics standards; - monitoring of the progress of the project, providing strategic supervision of the research activities and ensuring that the milestones, the deliverables and the results of the project are respected in accordance with the established timeline and the contractual requirements. • Cordinating scientific publications deriving from the project in accordance with the Grant Agreement contract and Consortium Agreement • Contributing to the statistical analysis of surveillance data

The study was carried out through the collaboration of three ORCHESTRA partners, the University of Bologna (UNIBO), the University of Verona (UNIVR) and the Service Andaluz de Salud (SAS), and is one of the systematic reviews developed for Work Package 2, Task 2.2, led by SAS. It was published in Clinical Microbiology and Infection.

Dear Scientists and Researchers,

You are invited to participate in the ORCHESTRA Science Challenge. We offer you a customised, anonymised dataset of high-quality patient data from our international cohorts to find answers to your COVID-19-related research question. An ORCHESTRA committee assesses the scientific suitability of the research project and ensures that accepted participation is handled in compliance with the publication policy. The research topics are: Fragile population Therapy algorithms Vaccination efficacy Please formulate your own research question, which should be: Concise Relevant Beneficial Evaluation criteria will include: Quality of the research question Study conduct Thoroughness and scientific standards Impact Novelty The enrolment period starts after the summer holidays. We wish to give you enough time to fit the Science Challenge into your schedule. The Challenge itself starts on 01 September, due date for submitting your work will be 15 October. Accredited study groups of scientists are eligible. The jury consists of ORCHESTRA members.

With kind regards on behalf of the entire ORCHESTRA team, Work Package 10

Partners were presenting one year of dedicated work to build up research infrastructure and conduct research on COVID-19. Large-scale European and international cohort research in the spirit of collaboration. 10 presentations from ORCHESTRA partners, more than 110 people attending. Great appreciation goes to the teams for their constant work and also to the Advisory Panel, Ethics Board and European Commission for the support and advice. ORCHESTRA’s leader, Prof. Evelina Tacconelli, welcomed the attendees and gave a project update. From the side of the European Commission, Stefanie Sowinski reported on “Cohorts united against COVID-19”, an initiative of coordination and collaboration of EU-funded projects establishing COVID-19 cohorts in Europe and beyond. Gabriella Scipione from CINECA presented the highlights of Work Package 7, responsible for data management – a major task in the project. Laurence Meyer from INSERM spoke for WP3 – Population-based cohorts working on Infection risk factors focusing on assessment of genotypic and microbiome analyses and intra-household transmissions. Evelina Tacconelli from the University of Verona, leader of ORCHESTRA and Work Package 2, presented the work on long-term consequences. WP4 - Fragile population cohorts explores protection and treatment interventions for fragile populations, Maddalena Giannella, University of Bologna, presented for the team. Paolo Boffetta, University of Bologna, explained why health worker cohorts - WP5 - are particularly interesting for evaluation: High exposure risk, good exposure data, early vaccination experience and medical surveillance. WP6 - Biobanking, genomics and virus-host interactions assesses the microbiological epigenetic aspects of COVID-19. Surbhi Malhotra-Kumar from the University of Antwerp spoke for WP6. Jan Hasenauer, Helmholtz Munich, presented the work of WP8 - Statistical/Cost Analysis and Modelling, which includes standardising the analysis workflow, creating statistical analysis plans, assessing data quality (e.g. checking for outliers and inconsistencies) and semi-automated reporting. WP9 - Global COVID-19 guidance assesses the ORCHESTRA research and draws medical and scientific recommendations from it. Daniele Pantano, University Medical Center Groningen, reported for WP9. Wp 10, responsible for dissemination, was presented by Janne Vehreschild, University Hospital of Cologne. ORCHESTRA is a collaborative project and the speakers presented on behalf of the entire team. You can find all partners here.

The persistence of symptoms after infection with SARS-CoV-2 can last for many months and has been defined as a clinical entity called Long COVID. Long COVID affects patients with numerous symptoms such as fatigue, headaches, breathing difficulties, difficulty concentrating ("brain fog"), chest pain and many more, which impair daily life. "Determinants of symptom persistence and impact on physical and mental well-being in long COVID: A prospective cohort study" is a study investigating the health status of patients after COVID-19 infection. The University of Verona (Italy) enrolled over 400 patients who were hospitalised or treated at home for COVID-19 and whose symptoms, particularly muscle pain, fatigue and breathing difficulties, persisted for up to 9 months after the acute illness. Physical and psychological well-being was influenced by the duration and number of symptoms, and factors such as ICU hospitalisation and age had an impact favouring Long COVID. Our findings encourage follow-up of patients at risk of Long COVID. The ORCHESTRA project makes an important contribution to the management of patients recovering from SARS-CoV-2 infection by providing outpatient appointments for blood tests, radiological examinations and specialist visits.

A better understanding of the COVID-19 disease course in non-hospitalised patients is needed to guide standard of care to properly manage patients at home, administer early treatment and predict progression to severe or chronic disease on time. The work will be mainly done within the ZonMw funded project COVID-HOME in close collaboration with other COVID-19 research projects e.g. the EU H2020 ORCHESTRA project. The COVID-HOME study is a prospective cohort study of non-hospitalised COVID-19 patients followed at home. Consenting people were visited weekly at home to obtain clinical data and samples to determine laboratory parameters, serology, viral genotyping, viral culture, and cytokine dynamics. Household members of infected individuals were also invited to join the study. The follow-up of the cohort at 3, 6, 12 & 18 month time-points is currently ongoing.

The Partners Meeting on November 26th was a very special one. One year of collaboration provided a vast variety of presentations on the agenda. The topics were around: the achievements within the Work Packages, introduction of new cohorts (welcome again, we appreciate collaboration), new studies on population-based cohorts, psychological impact and Parkinson cohorts, cohort enrolment in non-EU countries, COVID-19 in children, pregnant women, HIV-patients and so much more. Around 20 speakers presenting for different ORCHESTRA partners provided information on achievements, work-in-progress and scientific goals during this three-hours-meeting with 120 participants. In despite of the vastness of the program – it could only provide an idea of the great amount of work being achieved throughout one entire year. The past year - creating a network from scratch - has brought up many challenges. Not only have the partners worked on their own research tasks but also spent a great amount of time and effort on making the collaboration within ORCHESTRA work: creating ORCHESTRA wide standards suitable for international collaboration, harmonising data and finding research responses to the changes in the course of the pandemic – just to name a few.

Two post-doctoral positions in mathematical modelling of infectious diseases of 24 months each are available to work in Paris between Institut Pasteur and Inserm (UMR 1137) within the European project ORCHESTRA. The post-holders will work on the mathematical modelling of Covid-19 transmission in the community through the development of a multi-scale model combining both within- and the between-host viral dynamics. Applicants should have a PhD in infectious disease epidemiology, mathematical modelling, biostatistics or computational biology. They should have a strong background in computer programming, modelling and statistics, and excellent communication skills. Experience in infectious disease epidemiology would be an advantage.

The ORCHESTRA team at University of Verona is looking for: 1) One research scholarship in the disciplinary sector MED/17 to perform the research on the topic:  "Combatting Bacterial Resistance in Europe -Molecules Against Gram Negative Infections" 2) One research scholarship in the disciplinary sector MED/17 to perform the research on the topic: "Connecting European Cohorts to Increase Common and Effective Response to SARS-CoV-2 Pandemic: ORCHESTRA”

The ORCHESTRA General Assembly Meeting was held via Zoom Video Conference on 14 April 2021. More than 120 participants from more than 30 different countries have participated in the meeting comprising both representatives of the ORCHESTRA consortium and third parties as well as the European Commission Project Officer and the Advisory Panel, including representatives from the European Center for Disease Prevention and Control (ECDC) and the European Medicine Agency (EMA). The General Assembly meeting was the first meeting involving all partners for a formal discussion of the project work progress after the launch of the project (01.12.2020) and the Kick of Meeting (3-4.12.2020). It allowed partners to provide an update on activities undertaken since project inception. In addition, partners discussed the new tasks that have been assigned to the Consortium to include the analysis of SARS CoV-2 variants and vaccine response with the additional budget from the European Commission. The meeting has been organized as plenary sessions, with a time slot for each WP during which the WP leaders and co-leaders presented the tasks and partners involved, the major achievements, the milestones and deliverables of the period (M1-M6) and the publications, communication and dissemination strategy (M1-M12).

December 3rd and 4th 2020, project partners and international stakeholders met virtually to discuss the project strategy for the next three years.

The conference was attended by 186 participants, from 35 different organisations: the 26 beneficiaries, plus the international partners THSTI (Transnational Health Science and Technology Institute), CBCI(CBCI Society for Medical Education), UNIFESP (Universidade Federal de Sao Paulo), the European Commission, ECDC (European Centre for Disease Prevention and Control), EMA (European Medicines Agency), Azienda Zero of the Veneto Region, European Delegation to India, DBT (Department of Biotechnology, Government of India).

The main objectives of the Kick-Off Meeting:
To provide an overview of the milestones to be reached and deliverables for all the Work Packages
To allow partners to meet and organise the intra-WP collaborative work requested for each task objectives
To highlight Work Package strengths, possible challenges and connections in order to better organise the internal communication.