Consortium
KEY FACTS
FUNDING PROGRAMME
DURATION
01.08.2021 – 31.07.2025
BUDGET
Partners
Project Coordinator
Frankfurt, Germany
Goethe University was founded in 1914 as a unique ‘citizens’ university’, financed by wealthy citizens in Frankfurt, Germany. Named in 1932 after one of the city’s most famous natives, Johann Wolfgang von Goethe, today the university has over 48,000 students. The University Hospital Frankfurt (UHF) consists of 32 specialist clinics and clinical institutes as well as more than 20 research institutes and, together with the Goethe University Frankfurt, ensures the link be-tween teaching, research and health care. The Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy (KAIS), as the central facility of the UHF (1,500 beds), supplies all operative and diagnostic areas and provides over 30,000 anaesthetic procedures every year. KAIS is running several anaesthetic-operative intensive care units (over 50 beds). In addition, we regularly care for patients of other specialist intensive care and monitoring wards. Our pain clinic looks after both out- and inpatients with chronic and acute postoperative pain.
Role within COVend
The Goethe University Frankfurt (GUF) takes a leadership role as the Project Coordinator of the COVend project. GUF’s responsibilities encompass overall project management and Consortium liaison, ensuring that COVend’s objectives are achieved and the collaboration with other initiatives are added value to the project including the clinical trial planning and implementation, research and innovation management and outreach.
Research & Technology Partners
Zurich, Switzerland
accelopment Schweiz AG (accelCH) assists research institutions and companies in EU project manage-ment and the dissemination and exploitation of project results. The SME is specialised in European re-search, development and innovation support initiatives, such as Horizon 2020 and the SME-focused Eu-rostars programme. accelCH has a sister company, accelopment Deutschland GmbH (accelDE) located in Heidelberg, Germany. The core activities include professional project administration, consortium organisation and communica-tion, financial management and reporting, the facilitation of dissemination of project results to external stakeholders, and supporting the exploitation of project results. Well-established practical collaborative tools such as a secured Document Management System for knowledge exchange using open source soft-ware and an Excel-based developed Quality & Risk Management System developed by accelCH and used in dozens of EU projects, as well as numerous templates for management, dissemination and exploitation and a user-friendly, customised Content Management System (CMS) for the maintenance of the project website and online communication are readily available for use in this project.
Role within COVend
accelCH leads the work package on communication, dissemination and exploitation. This includes the development of materials and content, monitoring and evaluating the implementation of dissemination and communication activities. Furthermore, accelCH supports GUF in operational management in all aspects related to governance, administration, reporting, finances, contracts, and innovation management.
Brussels, Belgium
The European Society of Anaesthesiology and Intensive Care (ESAIC) is the largest professional community of anaesthesiologists in Europe. It covers 97 countries in Europe and worldwide and over 10.000 individual members. Its Secretariat is located in Brussels and employs 39 full-time staff, including education and exam coordinators, research project and data managers, research and clinical trial coordinators, technology and data managers, scientific programme coordinators, and several support staff, including finance, marketing and communications, quality management, and event management. With its research grants, the ESAIC gives much needed financial support to young anaesthesiologists, pilot studies and individual projects. The ESAIC also offer a series of established educational activities made available to the community of students, trainees, researchers, teachers, and professionals. Finally, to facilitate and harmonise the activities of anaesthesiologists across Europe, it regularly produces guidelines and reports concerning patient safety and quality of care regarding patients receiving or having received anaesthesia. In terms of dissemination, the ESAIC has its own journal: the European Journal of Anaesthesiology (EJD, Impact Factor: 4.140), which has 12 issues per year and ranks 6th in the field of Anaesthesiology. The ESAIC promotes continual improvement and setting of Quality Objectives in line with the ISO 9001:2015 Standard, as stated in the ESAIC Quality Charter document.
Role within COVend
As well as a key role in Communication and Dissemination, the ESAIC A-CRO coordinates the IXION 2.0 study in France, Lithuania, Romania and Spain. The ESAIC responsibilities include project management, monitoring and submission, and all data management tasks for these countries as well as Germany. Sylvia Daamen, Research Manager responsible for the ESAIC A-CRO team which includes Project Managers, Data Managers and Clinical Trial Assistants working on the IXION 2.0 study.
Frankfurt, Germany
The Fraunhofer Institute for Translational Medicine and Pharmacology ITMP investigates and develops innovative ways of early detection, diagnosis and treatment of diseases resulting from impaired function of the immune system. Innovation areas include Disease Models, 4D Clinic, OMICS-Technologies, Pharmaceutical Technology, and Proof-of-Concept & Clinical Studies.
Vienna, Austria
The SME F4 Pharma is a bio-pharmaceutical company established 2020 in Vienna. The company aims to convert high-impact scientific discoveries into pharmaceutical products for orphan diseases with high medical need. They develop and commercialise pharmaceuticals targeting capillary leak syndrome and systemic inflammation.
Role within COVend
Consortium partner F4 Pharma is developing an innovative drug called FX06 for diseases associated with systemic inflammation and capillary leak. With its new mode of action – not comparable to any drug on the market – FX06 is targeting a fundamental mechanism within the endothelial cells of the blood vessels, thus restoring and maintaining physiological permeability. A ph II study with FX06 in ARDS patients is in the centre of the COVend project and data from these patients, in combination with in vitro investigations, serve as the basis for elucidation of the molecular mechanism behind ARDS.
Tampere, Finland
Tampere University (TAU) was founded on the 1 of January in 2019 through the conjunction of the Tampere University of Technology (TUT) and the University of Tampere (UTA). The Faculty of Medicine and Health Technology (MET) is dedicated to pursuing world-class research and delivering high-quality education in the fields of biomedical engineering, biotechnology, medicine and health technology. The Faculty conducts research and innovation activities for example in the areas of cancer research and treatment, biomaterials and artificial organs, machine learning based clinical decision support and patient engagement and remote care e-solutions. The Personal Health Informatics (PHI) Group in the faculty studies and develops solutions through data science which aim to personalise care. The technical research areas include mobile health, health monitoring technologies, data mining, decision support systems, machine learning, biomedical data analysis and interpretation, computational modelling and data visualisation.
Role within COVend
COVend collects a wide variety of sources will such as omics, vital signs, and open registry data of the patients receiving FX06 and placebo. Tampere University’s role is to explore this data and apply advanced unsupervised clustering methods to characterize the patients. Based on this characterization, supervised artificial intelligence (AI) will be used to train machine learning models. These models will provide new insights into patient properties and recommend best known, personalised methods to treat the patient.
Dublin, Ireland
Systems Biology Ireland investigates new therapeutic approaches to disease on a systemic level using a combination of traditional wet-lab experimental analyses with computational modelling and simulation. The Eissner Group’s focus is on endothelial and mesenchymal stem cells in transplant medicine and oncology, i.e. the monitoring and preventing endothelial-specific adverse immunological reactions in transplant settings.
Role within COVend
WP5: Endothelial Cell Assessment
In WP5 we investigate the influence of COVID-19-triggered cytokines, as known to be present in patients’ sera, on viability, immunological as well as phenotypic changes, and transendothelial migration across human microvascular pulmonary endothelial cells. We also assess the protective role of FX06 to interfere with these pro-inflammatory actions and the underlying mechanism of action of the drug with wet and dry lab approaches.
Groningen, Netherlands
The University Medical Center Groningen (UMCG) is one of the largest hospitals in the Netherlands and the largest employer in the Northern part of the Country. More than 10000 employees are dedicated to provide patient care and cutting-edge scientific research, focused on ‘healthy and active ageing’.
The UMCG combines fundamental and patient-orientated clinical research. The interaction between these two stimulates the development of new clinical and research opportunities. UMCG is the Netherlands’ largest transplantation center and is one of the few hospitals in the world capable of performing every type of organ and tissue transplantation. The Department of Health Sciences in UMCG is leading the research in social-economic medicine, public health and global health economics issues. One of its units, Global Health (headed by Prof Maarten J Postma as professor of Global Health Economics), is focusing on international education and research including health economics of infectious diseases’ control. The unit has rapidly expanded from a staff of six employees to a group of 20 temporary Ph.D.s and postdocs, collaborating with many global health experts in clinical departments of hospitals, universities and beyond (with co-operations in Eastern Europe, Indonesia, Myanmar, South Africa, Zimbabwe, Brazil and Vietnam).
Role within COVend
Lead of WP7: Socio-economic impact and cost-effectiveness analyses (HTA). Evaluate FX06 from a health economic perspective and identify relevant policies and barriers affecting the feasibility of its implementation.
iDA Smart Digital Solution GmbH (iDA-SDS)
Marburg, Germany
Medical Intelligent Data Analytics is a software company that offers services ranging from conception and software development to the operation of components and systems. The company specializes in the fields of information technology, pharmaceuticals, medicine, and medical technology.
Clinical Partners
Kaunas, Lithuania
Kauno klinikos is the leading academic medical centre in Lithuania, renowned for clinical excellence, groundbreaking research, and innovative medical education. Established in 1940, our hospital unites tradition and innovation, operating as a modern healthcare campus with state-of-the-art facilities. Employing nearly 8,000 dedicated professionals—including over 2,300 highly-skilled physicians, 1,000 medical residents, 2,600 specialized nurses, of whom 540 are accomplished researchers—Kauno klinikos annually serves over 1.5 million outpatient visits and approximately 96,000 inpatient admissions. Our multidisciplinary approach, international collaborations, and pioneering treatments position us at the forefront of healthcare advancement in the Baltic region and beyond.
Role within COVend
The site is responsible for the recruitment of patients with respiratory insufficiency due to mild or moderate ARDS, to assess the potential effect of FX06 to improve the disease severity.
Barcelona, Spain
The Institut Catala de la Salut (Catalan Health Institute, ICS) participated in COVend through the Hospital Universitari de Bellvitge (HUB), located in the city of L’Hospitalet de Llobregat in the southern part of the Health Region of Barcelona. This hospital is situated in a region serving an estimated population of 1.3 million inhabitants. The Intensive Care Department at HUB has 56 beds divided into four units (medical, surgical, cardiac surgery and neurocritical) and is admitting over 1,500 patients annually. As a partner of HUB, the non-for-profit research institution Institut d’Investigació Biomèdica de Bellvitge (IDIBELL), carries out and manages research activities in the area of biomedicine – both basic and clinical research. It manages the scientific activities of researchers at the University Hospital of Bellvitge (HUB), the Catalan Institute of Oncology (ICO) and the University of Barcelona-Bellvitge Campus (UB), each of which is a separate entity to IDIBELL.
Role within COVend
The site is responsible for the recruitment of patients with respiratory insufficiency due to mild or moderate ARDS, to assess the potential effect of FX06 to improve the disease severity.
Bucharest, Romania
Carol Davila University of Medicine and Pharmacy or University of Medicine and Pharmacy Bucharest, commonly known by the abbreviation UMFCD, is a public health sciences university in Bucharest, Romania. It is one of the largest and oldest institutions of its kind in Romania.
Role within COVend
The site is responsible for the recruitment of patients with respiratory insufficiency due to mild or moderate ARDS, to assess the potential effect of FX06 to improve the disease severity.
Paris, France
Greater Paris University Hospitals is the university hospital trust operating in Paris and its surroundings. It is the largest hospital system in Europe and one of the largest in the world. It employs more than 90,000 people in 38 teaching hospitals and receives more than 10 million annual patient visits.
Role within COVend
The site is responsible for the recruitment of patients with respiratory insufficiency due to mild or moderate ARDS, to assess the potential effect of FX06 to improve the disease severity.