CONSORTIUM

1

INSERM – ANRS MIE
Paris, France

2

Oslo Universitetssykehus HF
Oslo, Norway

3

Universita degli studi di Verona
Verona, Italy

4

Inserm Transfert SA
France

5

Assistance Publique des Hôpitaux de Paris
Paris, France

6

Servicio Madrileno de Salud
Madrid, Spain

7

European Clinical Research Alliance on Infectious Diseases
Utrecht, Netherlands

8

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Utrecht, Netherlands

9

UNIVERSITEIT ANTWERPEN
Antwerpen, Belgium

10

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Rotterdam, Netherlands

11

FUNDACAO OSWALDO CRUZ
Brazil

12

Folkehelseinstituttet
Norway

13

PANTHER
France

14

UNIVERSITAT BASEL
Basel, Switzerland

15

University of Geneva
Geneva, Switzerland

16

Fundación Huésped
Argentina

1

INSERM - ANRS MIE
Paris, France

Yazdan Yazdanpanah
Professor

Alpha Dialo
Dr.

Erica Telford
Clinical trial manager

ANRS Emerging Infectious Diseases (ANRS MIE) is an autonomous agency of Inserm that facilitates, evaluates, coordinates and funds research into HIV/AIDS, viral hepatitis, sexually transmitted infections, tuberculosis and emerging and re-emerging infectious diseases. We prepare responses to the scientific challenges pose by emerging diseases and ensure their deployment in times of crisis.

Objective
The ANRS Emergine Infectious Disease is the coordinator of the project and the study sponsor of the UNITY study. Additionally, ANRS MIE is responsible for setting up and overseeing a centralized pharmacovigilance system within the project. This system is designed to streamline the management of safety data and ensure the safety of participants in the trial.

2

Oslo Universitetssykehus HF
Oslo, Norway

Inge Christoffer Olsen
Doctor

Oslo University Hospital is a highly specialised hospital in charge of extensive regional and local hospital assignments and the provision of high quality services for the citizens of Oslo. The hospital also has a nationwide responsibility for a number of national and multi-regional assignments and has several national centres of competence.

Division of Critical Care and Emergencies as well as Section of Clinical Immunology and Infectious Diseases are involved in all research activities related to COVID-19 infected patients and serve also as national leading units organizing and running the NOR-SOLIDARITY trial. Both departments are strongly involved in different international collaboration and in Nordic collaboration through the Scandinavian Society of Anaesthesia and Intensive Care (SSAI) and Nordic Trial Alliance (NTA). Furthermore, both departments have huge interest in developing a strong collaborating research network combing infectious diseases and intensive care medicine.

Objective

Oslo University Hospital will play a crucial role in data management for the project. The institution will establish a dedicated data sharing repository hosted at the University of Oslo. Additionally, OUH takes on the responsibility for coordinating the development of statistical methodology to be used in the project. 

3

Universita degli studi di Verona
Verona, Italy

Evelina Tacconelli
Professor

The University of Verona is a public University focusing on innovation and research, internationally renowned in the area of biomedical and infectious diseases research.

The University Hospital is 1,600-bed medical center including all medical specialties. The Infectious Diseases Section, within the Dept. of Diagnostics and Public Health, has extensive clinical and research activities with a multidisciplinary team involving > 80 members with different specialities (infectious diseases, internal medicine, microbiology, biology, statistic, bio-statistic, infection control, psychologist) coordinating and participating to several national and international projects funded by a range of different donor programmes (e.g. WHO, GARDP, IMI, Horizon2020, JPI-AMR, AIFA, and ESCMID).

Research topics include therapy of severe bacterial infections caused by multidrug-resistant bacteria, prevention of healthcare associated infections, optimization of surveillance systems, antibiotic stewardship, diagnostic stewardship, AMR transmission and burden, STIs and Public Health. 

Objective

UNIVR will be involved in the development of the MOSAIC protocol and will also serve as recruiting centers for the MOSAIC study.

4

Inserm Transfert SA
France

Founded in 2000, Inserm Transfert is the private subsidiary of the French National Institute of the Health and Medical Research (INSERM), dedicated to technology transfer (ie from invention disclosure to industrial partnership). Inserm Transfert runs a comprehensive set of technology transfer activities from classical value chain activities to unique solutions:

  • Scouting & Intellectual property management, with a philosophy of giving a chance to all innovations (portfolio of 1673 patent families in 2017)
  • Early development & Proof-of concept support for therapeutics and diagnostics (biomarkers), with a philosophy of maximum consolidation of the earliest phases, with more than 15 M€ since 2009 with the objective to create value. IT runs €2 million proof-of-concept fund per year. In 2017, 281 projects were detected and about 400 contracts and licences were signed.
  • Setting up public multi-private partnerships on cohorts, databases, biobanks & public health management Its Collaborative Research Funding department of IT (formerly named European Affairs Department) supports the set-up and management of large-scale projects in biomedical research notably including infectious diseases, epidemiology and public health

Objective

Inserm Transfert support IT for the coordination and project management of MPX-RESPONSE.

5

Assistance Publique des Hôpitaux de Paris
Paris, France

Xavier LESCURE
Professor

Cédric Laouenan
Professor

Assistance Publique-Hôpitaux de Paris (AP-HP) is the biggest teaching hospital in Europe, federating 39 different hospitals and groups of hospitals (22,474 beds) mainly located in Paris and its suburban area. It offers advanced treatments to 8M patients per year, including 1.5M hospitalizations (10% of all hospitalizations in France). It is also the largest employer in the Paris region with 92,000 people working for this public institution representing more than 150 different jobs.

With more than 19,000 medical staff, 3000 hospital physicians, including 1000 professors and more than 6000 residents and medical students, AP-HP's staff cover all the major medical specialities.

As a public health institution, AP-HP pursues 3 main missions: healthcare delivery, medical and paramedical teaching and biomedical and clinical research. AP-HP' teams develop high quality research activities, including European and International Research projects. In particular, AP-HP is involved and/or co-ordinates more than 80 European research projects supported by the Research and Technological Development Research Programme from the European Union. AP-HP is also the first biomedical research center in Europe with > 500 clinical trials per year and > 8,000 publications per year (25% of all medical research publications in France). It represents the leading sponsor of clinical trials in France and Europe. The Clinical Research and Innovation Delegation (DRCI) is responsible for managing and monitoring all research and the resources needed to achieve them, in line with good clinical practice and patient safety.

Objective

APHP will contribute, together with UNIVR to the protocol development of MOSAIC. APHP is in charge of coordinating  the MOSAIC cohort, the data management, statistical analysis and dissemination of the results. It will also participate as recruiting center.

6

Servicio Madrileno de Salud
Madrid, Spain

José Ramón ARRIBAS LÓPEZ
Professor

SERMAS constitutes the Public Health System for the Madrid Autonomous Region, Spain. Along with its clinical facilities, like La Paz University Hospital–HULP, also holds several research institutes such as the Hospital La Paz Institute for Health Research–IdiPAZ.

HULP is the flagship general tertiary hospital in the Madrid Autonomous Region, serving to an area in excess of 500000 people.

As the first modern-concept hospital built in Spain it has kept its prestige over the years, being recognised as the best-valued among public-owned hospital through the years. It is noteworthy its position as main reference in Spain for handling emergent infective threats, being the only hospital in Europe that successfully treat both COVID-19, Ebola an Crimea-Congo fever. IdiPAZ institute concentrates the clinical, translational and experimental research of the La Paz University Hospital. The institute harbours 55 research groups distributed in six main research areas: neurosciences; cardiovascular; infectious diseases and immunity; organ system pathologies; cancer and human molecular genetics; and surgery, transplant and health technologies. And a series of common core platforms (Clinical Trials, Molecular Medicine, 3D printing etc.) aimed to ensure the synergies among the research groups and with the hospital wards.

Objective

SERMAS is involved in the coordination and conduct of EPOXI. It will also participate as recruiting center for the MOSAIC study and the EPOXI trial.

7

European Clinical Research Alliance on Infectious Diseases
Utrecht, Netherlands

Lina Gurskaite
Senior clinical trial project manager

Marc Bonten
Chief Executive Officer

The European Clinical Research Alliance for Infectious Diseases (Ecraid) is a not-for profit, foundation that advances clinical research in the field of infectious diseases through international collaboration. Headquartered in Utrecht, the Netherlands, Ecraid offers a single point of access to Europe’s largest academic clinical research network for infectious diseases that spans over 1,250 clinical sites and 900 laboratories across 42 countries. For more information, visit www.ecraid.eu.

Objective

Ecraid will contribute with UMCU to the protocol development of EPOXI, the obtaining of regulatory approvals, the coordination and conduct of the EPOXI study, and the data management.

8

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Utrecht, Netherlands

Miquel Ekkelenkamp
Doctor

UMC Utrecht is a leading international university medical center generating, testing, sharing, and applying knowledge on health, illness, and health care for the benefit of patients and society. With approximately 12,000 employees, the University Medical Center Utrecht is one of the largest public health care institutions in the Netherlands.

Objective

UMCU acts as the central sponsor and scientific lead of EPOXI. It is responsible , with the support of Ecraid, for developing the protocol of EPOXI, securing regulatory approvals, and overseeing the coordination and implementation of the study.

Additionally, UMCU will handle the statistical analysis of the EPOXI Study and dissemination of the results.

9

UNIVERSITEIT ANTWERPEN
Antwerpen, Belgium

Surbhi Malhotra-Kumar
Professor

Christine Lammens

Leen Timbermont
Postdoctoral researcher

Sofie Van Mieghem
Lab technician

The University of Antwerp (UAntwerp) is a vibrant and forward-thinking institution driven by a robust mission and vision. Committed to making a positive impact on society, the university combines its rich heritage with contemporary thinking, creating a distinctive place in the academic realm.

The Laboratory of Medical Microbiology (LMM) has a broad base in medical microbiological research and is well-recognized internationally for its multidisciplinary translational approach to studying pathogens and infections. On one hand, we are heavily involved in utilizing state-of-the-art molecular techniques to study the evolution and transmission dynamics of (resistant) pathogens both in patients over time as well as in hospitals and in the community. On the other hand, the LMM team is responsible for establishing, training, and maintaining LAB-Net, a high-quality geographically representative European network of diagnostic microbiology laboratories. This network supports observational and interventional clinical trials on drug development for infectious diseases.

LMM has accumulated vast experience in coordinating and managing large scientific consortia with an impressive track record of participation in international projects and more than 800 publications in peer reviewed journals.

Objective

UAntwerp will serve as the central laboratory and biobank in the EPOXI trial. It will oversee the sample handling and transportation.

10

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Rotterdam, Netherlands

Marion Koopman
Professor

Dr Luca Zaeck
Post-doctoral researcher

Dr Bas Oude Munnink
Assistant professor

Rory de Vries
Associate professor

Corine Geurts van Kessel
Clinical virologist / Associate professor

The Department of Viroscience of the Erasmus MC is an international centre of excellence for multidisciplinary, basic, translational and clinical research of viruses and virus infections at the molecular, patient and population level. The unique aspect of the Department of Viroscience is its translational approach, with expertise ranging from basic virology to clinical virology, connecting medical and veterinary health, public health and ecology. By combining these complementary areas of expertise The Department of Viroscience is able to meet today's and tomorrow's societal challenges in diseases caused by common and newly emerging viruses.

The Department of Viroscience is Reference Centre for:

  1. WHO Collaborating Centre for Arbovirus and Haemorrhagic Fever Reference and Research
  2. WHO National Reference Laboratory Centre - Measles & Rubella
  3. National Reference Centre for Influenza and Emerging Infections in The Netherlands

Professor Marion Koopmans, Head of the Department of Viroscience, is also part of the international team of the current WHO-convened Global Study of the Origins of SARS-CoV-2 China studies (November 2020).

Additional information about Erasmus MC on the website: About Erasmus MC - Erasmus MC

Objective

EMC will participate as recruiting center in the EPOXI trial. Besides, it act as central laboratory to perform sample analysis for EPOXI.

11

FUNDACAO OSWALDO CRUZ
Brazil

Beatriz Grinsztejn
Professor

Valdilea Veloso
Professor

Objective

Fiocruz FH will participate in the UNITY study as a recruiting country and sponsor for Brazil.

12

Folkehelseinstituttet
Norway

Victoria Charlotte Simensen
Doctor

The Norwegian Institute of Public Health is a government agency under the Ministry of Health and Care Services.  NIPH is as well involved in international collaboration in health in several areas and research both at national and international level constitute an important part of the activity in the institute. NIPH is the Norwegian partner in the Clinical Research Initiative for Global Health (CRIGH) to facilitate international collaboration in clinical trials with secretariat at the ECRIN office in Paris.

Objective

NIPH plays a pivotal role in supporting the Trial Coordination Board (TCB) within Work Package 1 (WP1). NIPH, driven by its leadership, facilitates collaboration and synergy between MPX-RESPONSE and other European Adaptive Platform Trials (APTs) related to emerging infectious diseases.

13

PANTHER
France

Nathalie Strub-Wourgaft
Doctor

PANTHER’s vision is to effectively contribute to the control of future emerging epidemics or pandemics through a flexible clinical research platform response, supporting preparedness and rapid response to emerging infectious diseases via the development of tools (DTV), with a focus on Low- and Middle-Income Countries (LMICs).

PANTHER aims to develop, implement and sustain a “ready to use” living clinical research platform which integrates research capacity in clinical care.

The platform will provide the human and technical infrastructure to timely address LMICs’ medical research questions through a network of equipped and trained researchers combining experienced African research centres with healthcare sites in key population areas and more remote locations.

Objective

PANTHER will act as the central sponsor and scientific lead of MOSA.

14

UNIVERSITAT BASEL
Basel, Switzerland

Matthias Briel
Professor

Alain Amstutz
Doctor

Founded in 1460, the University of Basel (https://www.unibas.ch/en.html) is among the leading public institutions of higher education and the oldest university in Switzerland. The Faculty of Medicine is the largest faculty with its five research departments of Biomedicine, Biomedical Engineering, Public Health, Clinical Research, and Sport, Exercise and Health. The university strives for scientific excellence and has educated several Nobel laureates.

Objective

UNIBAS will be involved in the UNITY trial and the MOSAIC cohort. For MOSAIC, UNIBAS will contribute to the statistical analyses. For UNITY, UNIBAS will be responsible for a potential systematic review and individual patient data meta-analysis, summarizing available randomized evidence of the intervention under evaluation, and will contribute to the statistical analyses and the set-up of a global trial data sharing framework.

 

15

University of Geneva
Geneva, Switzerland

Alexandra Calmy
Professor

Laetitia Guiraud
Doctor
Clinical project manager

Founded in 1559, the University of Geneva (UNIGE) enjoys worldwide recognition and ranks amongst the top 100 best universities in the world.

A polyvalent institution, it fosters the emergence of inter- and multidisciplinary fields in both research and teaching. It constantly strengthens its links with international Geneva, whilst contributing to the cultural, social and economic development of the region, notably through the promotion of research and its expertise in a wide range of fields. UNIGE is involved in 220 joint projects with world-renowned universities through strategic partnerships including seed funds. At a European level, UNIGE actively participates in EU research programmes, in particular the EU Framework Programmes for Research and Innovation with some 500 participations in total, including 25 project coordinations and over 90 prestigious European Research Council grants (FP7, Horizon 2020 and Horizon Europe taken together).

Objective

UNIGE-HUG will participate in the UNITY study as a recruiting country and will coordinate some aspects of the study. In this capacity, it will manage protocol amendments and local regulatory aspects. Furthermore, UNIGE-HUG is the investigational medicinal products (IMPs) coordinating centre for the Unity study, and  will handle the ordering, labeling, and repackaging of IMPs for Switzerland, Brazil and Argentina.

 

16

Fundación Huésped
Argentina

Pedro Cahn
Professor

Fundación Huésped is an Argentine NGO with regional scope that, since 1989, works in public health with the objective that the control of diseases and health rights are guaranteed. Our comprehensive approach includes research, practical solutions and communications associated with public health policies in Argentina and Latin America.Our mission is to develop scientific research and preventive and rights-based interventions to ensure access to health and reduce the impact of disease, with a focus on HIV/AIDS, viral hepatitis, vaccine-preventable and other infectious diseases, and sexual and reproductive health. Our vision is to work for a society free of stigma and discrimination in which anyone has access to healthcare in an egalitarian way and where public policy is based on scientific evidence.

Objective

FH will participate in the UNITY study as a recruiting country and sponsor for Argentina.