Clinical outcome in solid organ transplant recipients affected by COVID

Clinical outcome in solid organ transplant recipients affected by COVID-19 compared to general population: a systematic review and meta-analysis

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.
Five questions about the research to Maddalena Gianella, leader of Work Package 4, an associate professor at the Department of Medical and Surgical Sciences at the University of Bologna, and who provides the information on behalf of the team of Work Package 2.

What is the purpose of the study?
A significantly increased risk of complications and mortality has been described in immunocompromised patients affected by COVID-19. However, the effects of COVID-19 in solid organ transplant recipients (SOT recipipients) are still debated due to conflicting evidence from various observational studies. We wanted to investigate the evidence and provide clarity on this issue.

What was the method/what has been done to answer the purpose?
We performed a systematic review with meta-analysis to assess the clinical outcome in SOT recipients with COVID-19 compared to the general population. 3,501 articles were screened, and thirty-one observational studies were included in the meta-analyses. We evaluated the data sources PubMed-MEDLINE and Scopus. Both were independently searched until 13 October 2021. The study eligibility criteria (guidelines for who can or cannot participate in the study) were: Prospective or retrospective observational studies comparing clinical outcome in SOT recipients versus general populations affected by COVID-19. Primary endpoint was the 30-day mortality. Participants of the study were patients with confirmed COVID-19 exposure. The assessment of risk of bias was performed according to the ROBINS-I tool for observational studies.

What are the learnings?:
In our primary analysis, which included studies adjusting for confounding factors, we found no difference in the 30-day mortality rates. No evidence of publication bias was reported. Still, we found a higher risk of ICU admission and occurrence of acute kidney injury in SOT recipients.
What is your conclusion?
No increased risk in mortality was found in SOT recipients affected by COVID-19 compared to the general population when adjusted for demographic and clinical features and COVID-19 severity.

What are the benefits for the public? This finding can inform public health in potential complications and clinical course of COVID-19 in SOT patients.

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Work Package 1: The Project Management Unit

ORCHESTRA’s mission is to bring together European and international partners in order to create larger cohort research for collaborating on a clearer picture of COVID-19 to find evidence based medical recommendations. 37 partners from 15 countries join work forces to achieve this goal. Only a well organised research infrastructure with common standards can facilitate serious research of this size. International teams of specialists from different professional backgrounds are assigned to eleven work packages – each entrusted with important tasks (which inspired the project’s name ORCHESTRA). Obviously, this endeavour requires a great amount of coordination, which is in the hands of Work Package 1 (WP1), the project management unit.

WP1 is ORCHESTRA’s “ground control” and provides continuous support to the partners in all aspects of project management, supervises adherence to the Grant Agreement, Consortium Agreement and Publication Policy, facilitates the flow of information between the ORCHESTRA partners and the many stakeholders. Currently, WP1 is also working on the internal financial reporting. This is a valuable practice for helping partners monitor their expenditure and it will facilitate partners when it comes to the official financial reporting activity to the European Commission due this summer. The next important task will be the official project reporting to the European Commission, requiring all the partners to report financial expenses and scientific activities performed in the first 18 months of the project. The team of WP1 describes their work challenge: “Coordinating such a big Consortium is a continuous challenge given the changes and adjustments needed to keep the project updated with the constantly evolving epidemiological situation. These changes indeed have impacted not only the scientific research but also the administrative and financial management of the project.”
The lead of this work package has a team from the University of Verona.

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Clinical outcome in solid organ transplant recipients affected by COVID

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.

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ORCHESTRA BEHIND THE SCENES 4

ORCHESTRA is an international project about cohort research on COVID-19. The larger the patient number in the cohorts, the greater becomes the chance of creating a wide clinical picture of the disease. This is why ORCHESTRA is open to collaborate with external cohorts and what motivates external cohorts to join ORCHESTRA. Seamas Donnelly, Professor of Medicine at Trinity College, Dublin, Ireland, took initiative earlier this year. He looked at the website of the European Commission to find out about medical initiatives, found and contacted ORCHESTRA, spread the news within a network of two prominent Dublin hospitals (The St James’s, Tallaght University Hospital, Trinity Alliance for Research – STTAR), joined ORCHESTRA and holds the lead of the Irish Cohort within ORCHESTRA.

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ORCHESTRA BEHIND THE SCENES 3

Cohort research plays an important role in the international efforts of COVID-19 research and it is the core of ORCHESTRA’s network. – But what exactly is cohort research about? This interview with Prof. Janne Vehreschild provides an overview of meaning, chances and challenges of cohort research in general and of ORCHESTRA in particular. Janne Vehreschild has the lead of ORCHESTRA partner University Hospital of Cologne (UHC), and brings in extensive experience in the field of cohort research in different medical disciplines.

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ORCHESTRA BEHIND THE SCENES 2

Keeping patient data as secure as possible is a central concern in the implementation of the ORCHESTRA network. Work Package 7, responsible for data management, addresses this task. The interview with Prof. Dr. Fabian Prasser from partner Berlin Institute of Health @Charité provides an insight into the challenges and the implications of the project for future research collaboration – and shows the importance of communication between the different partners.

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ORCHESTRA BEHIND THE SCENES

Work Package 7 (WP7) deals with the task of data management in ORCHESTRA, a task which is particularly challenging as ORCHESTRA has 26 beneficiaries and many third parties and collaborations from about 15 European and non-European countries involved and works with cohorts located in different countries. A cohort means a large number of patients which are grouped by certain categories. E.g. ORCHESTRA’s Healthcare Worker Cohort researches the immunisation status of healthcare workers after vaccination or COVID-19 infection. Cohort research relies very obviously on data extraction and data analysis. In order to be able to draw correct information from the data, ORCHESTRA depends on common standards and codes. Yet, medical standardisation and harmonisation is a worldwide challenge which is still work in progress. Prof. Dr. Sylvia Thun, Eugenia Rinaldi und Caroline Stellmach from Charité partner are tackling this important task and speak openly about challenges, motivation and visions.

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