Context

The emergence and the spread of SARS-CoV-2 is an unprecedented challenge, vividly illustrating the pace at which a viral outbreak can progress among a highly interlinked and susceptible global population and become a dangerous global pandemic. The COVID-19 crisis raises a major challenge for the European life sciences and medical research community who is urged to propose in the short term therapeutic and preventive solutions, including vaccines.

EU-RESPONSE allows the European expansion of the DisCoVeRy study, a phase III, open-label, adaptive, randomized, controlled, multi-centre clinical trial designed to evaluate the safety and efficacy of medicinal products in hospitalized adult patients diagnosed with COVID-19. The DisCoVeRy trial was originally initiated in France as a WHO Solidarity trial “add-on” study EU-RESPONSE enables its further expansion to many other European countries.

Additionally, EU-RESPONSE has built a new multinational European Adaptive Platform Trial, based on existing initiatives, experiences and competencies – this platform trial is EU-SolidAct. This is a flexible platform, providing a modular trial network enabling European hospitals to participate at the level of commitment that aligns with their capacity. Data collection ranges from clinical assessment parameters to PROMs and advanced biobanking.
EU-SolidAct will aim to run repurposing trials, evaluating combination strategies as well as evaluating efficacy and safety of new compounds entering clinical development on COVID 19″. The platform trial has the capacity for running both phase 2 and phase 3 trials. EU-SolidAct is designed to enable rapid reactivation in case of emerging infectious diseases and new epidemics.

The project also includes a coordination module with the EU-funded RECOVER project, led by ECRIN, ensuring complementarity and cooperation across all large European COVID-19 Adaptive Platform trials, and their capacity to answer the needs of society through dialogue with the EMA, national competent authorities, HTAs and industry partners.

Although in the short-term this project will focus on COVID-19, the mid- and long-term objectives are to build a platform trial network on emerging infectious diseases in general.

Objectives

The overall objective of this 5-year project is to build a multinational, adaptive European COVID-19 and emerging infectious diseases trial network, based on existing initiatives, experience and expertise, allowing European expansion of DisCoVeRy (WP1) and the establishment of a COVID-19 adaptive platform trial (WP2). 

Over a 5-year period, the specific objectives of the project are:

 

  • Expand, in the short-term, DisCoVeRy to many other EU Member States and Associated Countries (WP1).

 

  • Build a multinational, European multi-arm COVID-19 platform trial beyond DisCoVeRy (WP2).
    • Provide in the mid-term a modular trial framework
      within this platform.
    • Develop a second-generation master protocol
      targeting in particular COVID-19.

 

  • Coordinate the activities between different European COVID-19 Adaptive Platform trials, establishing a single coordination mechanism with a coordinated strategy aligned with European and national policies (WP3).

Secondary objectives are:

 

  • Develop a network of hospitals to conduct clinical trials evaluating treatment strategies in patients with COVID-19 and other emerging infectious diseases
    • Non ICU setting and ICU setting

 

  • Build a strong governance for the selection of treatment and strategies to be evaluated, targeting COVID-19 in the short term and other emerging infectious diseases in the longer term (other emerging infectious diseases might include new strains of influenza, recurrence of measles, Ebola, recurrence of tropical diseases due to climate changes, or spread of treatment-resistant infections such as Antimicrobial Resistance (AMR) or MDR-Tuberculosis)

Strategy

4 interrelated work packages have been put in place in order to achieve EU-RESPONSE’s goals

WP1

Extending DisCoVeRy in Europe

  • Expand, organize and conduct the DisCoVeRy clinical trial in EU member states and associated countries.
  • Ensure compliance of ethical and regulatory aspects.
  • Provide answers on the safety and efficacy of the repurposed medicines and investigational drugs.
  • Build the foundation of a proactive European network dedicated to emerging infectious diseases.

WP2

DisCoVeRy for Solidarity: a platform trial for COVID-19 and other emerging infectious diseases

  • Build a multinational, European Adaptive Platform Trial used for future clinical trials targeting COVID-19 in short-term and other emerging infectious diseases in the medium/long-term.
  • Build a strong trial governance accounting for all stakeholders.
  • Define the statistical strategies to maintain the scientific integrity of provided evidence.
  • Initiate and manage a first trial.

WP3

Coordination of the European COVID-19 Adaptive Platform trials

  • Optimal cooperation and coordination between the European Adaptive Platform Trials, through a dialogue with relevant stakeholders providing high-level specifications for their planning and design.
  • Building a bridge between RECOVER and EU-RESPONSE.
  • Development of a toolbox facilitating the design and development of Adaptive Platform Trials, ensuring cross-fertilization and dissemination across medical specialties.

WP4

Project management, coordination, communication and dissemination

  • Provide efficient management and administration of the project, while fulfilling all legal, regulatory, and ethical requirements.
  • Establish a functional management structure.
  • Dissemination and communication.
  • Develop the exploitation plan and sustainability plan.

Expected results

Across WPs 1-3, the expected main outcomes of EU-RESPONSE are:

WP1

Extending DisCoVeRy in Europe

Answers on the safety and efficacy of medicinal products in hospitalized adult patients diagnosed with COVID-19; while building the foundation of a proactive European network dedicated to emerging infectious diseases;

WP2

DisCoVeRy for Solidarity: a platform trial for COVID-19 and other emerging infectious diseases

Multinational, European Adaptive Platform Trial for future clinical trials targeting COVID-19 in short-term and other emerging infectious diseases in the medium/long-term.

WP3

Coordination of the European COVID-19 Adaptive Platform trials

Optimal cooperation and coordination between the European Adaptive Platform Trials, and coordinated decisions for addition of new treatment arms or domains

Toolbox for the design and development of Adaptive Platform Trials, ensuring cross-fertilization and dissemination across medical specialties.

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Project Information

Grant agreement ID: 101015736

Status: Ongoing project Overall

budget: € 15 719 450,13

Funding: H2020-EU.3.1.3.

cordis.europa.eu

Start date

1st of July 2020

End date

30th of June 2025

Coordinated by: INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE – France