European Research and Preparedness Network for Pandemics and Emerging Infectious Diseases

Grant number: 101015736

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2020
    2025
  • Known Financial Commitments (USD)

    $17,605,784
  • Funder

    European Commission
  • Principal Investigator

    Yazdanpanah Yazdan
  • Research Location

    France
  • Lead Research Institution

    INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
  • Research Priority Alignment

    N/A
  • Research Category

    Therapeutics research, development and implementation

  • Research Subcategory

    Prophylactic use of treatments

  • Special Interest Tags

    N/A

  • Study Type

    Non-Clinical

  • Clinical Trial Details

    N/A

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

Abstract

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 COVID19 adaptive platform trial (WP2). The DisCoVeRy trial, designed as a multi-arm adaptive repurposing trial, initiated in France, has the potential to expand to many other European countries with appropriate support in terms of multinational funding and trial management capacity. This will complete the evaluation of repurposed drugs, while building a European clinical trial network which, together with other European networks such as the Solidarity trial, will design and run a new European platform trial. EU-RESPONSE will swiftly generate robust evidence for drug repurposing or registration, through a modular trial framework allowing most European hospitals to participate at their preferred level of commitment, thus building a network of investigation sites within European and associated countries. Cooperation with other European platforms, in particular the RECOVER consortium platform will be achieved through a joint coordination mechanism aligned with European and national policies (WP3), ensuring a coordinated strategy for the European COVID-19 Adaptive Platform Trials, their complementarity in providing access for requests for a new domain or arm, their synergy and cross-fertilization through the development of a common toolbox for the development and the management of Adaptive Platform Trials. Joining forces in Europe and with international partners, it will contribute to the global clinical trial capacity for urgently meeting the expectations of society and developers. It will also boost multinational cooperation in Europe and promote the establishment of adaptive platform trials in other diseases, and will have a major impact on epidemic control.

Publicationslinked via Europe PMC

Antiviral effect of Evusheld in COVID-19 hospitalized patients infected with pre-Omicron or Omicron variants: a modelling analysis of the randomized DisCoVeRy trial.

Cardiac Adverse Events and Remdesivir in Hospitalized Patients With COVID-19: A Post Hoc Safety Analysis of the Randomized DisCoVeRy Trial.

Coordination of COVID-19 platform trials in Europe.

Experiences and challenges with the new European Clinical Trials Regulation.

Correction to Lancet Respir Med 2023; 11: 453-64.

Management of pharmacovigilance during the COVID-19 pandemic crisis by the safety department of an academic sponsor: Lessons learnt and challenges from the EU DisCoVeRy clinical trial.

Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial.

Effect of remdesivir on viral dynamics in COVID-19 hospitalized patients: a modelling analysis of the randomized, controlled, open-label DisCoVeRy trial.

Immunocompromised patients have been neglected in COVID-19 trials: a call for action.