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Coordination and Access for European COVID-19 Adaptive Platform Trials

The importance of cross-border cooperation and coordination in the fight against the global COVID-19 pandemic has been highlighted since it began. In particular, international clinical research efforts need to be connected and synchronized to ensure that results are obtained rapidly while remaining robust, reproducible and reliable.

With this aim in mind, two ambitious projects, EU-RESPONSE and RECOVER, have been financed by the European Commission and a joint coordination module has been established between them. This module allows them to address the most pressing research questions through large adaptive platform trials (APT), while avoiding duplications and maximizing the use of resources.

The EU-funded projects

RECOVER logoThe RECOVER project has a multidisciplinary approach to tackle the COVID-19 pandemic. It provides support for the activities and the expansion of the REMAP-CAP APT in Europe. Furthermore, the RECOVER project incorporates observational studies in the primary care and hospital settings, clinical biological studies including transcontinental cooperation, epidemiologic and modelling studies, and social science studies.

 

EU-RESPONSE logoEU-RESPONSE is a 5-year project that includes two broad Pan-European APTs, DisCoVeRy and EU-SolidAct. The EU-RESPONSE consortium is composed of 21 partners, bringing together multidisciplinary partners from across the continent. 

 

ECRAID-PRIME is a unique project that will assess COVID-19 treatments for non-hospitalized patients with the aim to speed up recovery and/or to prevent deterioration of illness and hospitalisation. By focusing on early phase clinical trials, the ECRAID-PRIME platform will be able to assess safety and efficacy of various treatments, helping to streamline them towards Phase III trials. ECRAID-PRIME will run the trials in a pan-European primary care Network.

 

The coordination module

The shared coordination module ensures optimal collaboration and complementarity between trials in the EU and abroad. It is composed of the Trial Coordination Board (TCB), the Joint Access Advisory Mechanism (JAAM) and the Adaptive Platform Trial Toolbox.

Co-led by the European Clinical Research Infrastructure Network (ECRIN) and the Norwegian Institute of Public Health (NIPH), the coordination module strives to bring to the table all key stakeholders for platform trial development and implementation, to discuss and make recommendations on the development of the European platform trials, and to identify and develop strategic partnerships. Through the JAAM it provides a single access point for new and repurposed drugs, developed by the industry or academia, to join the European APT. Furthermore, this module provides an array of tools that can be used to design, implement and manage APT for COVID-19 and other disease areas.

The adaptive platform trials

REMAP-CAP stands for Randomised, Embedded, Multi-factorial, Adaptive Platform trial for Community-Acquired Pneumonia. This global adaptive platform trial, aimed towards finding the best treatement for community-acquired pneumonia, is multifactorial and flexible, allowing it to rapidly adapt as planned, to include COVID-19 patients. Supported by the RECOVER project, REMAP-CAP continues to investigate several treatments for COVID-19 and supports a growing network of study sites across the European continent.

The design of the REMAP-CAP for participants with suspected or proven to have COVID-19 is as follows:

REMAP CAP Scheme

 

To learn more on how to become involved REMAP-CAP trial click here. Additional details on the trial can be found here.

The EU-SolidAct trial kicked off in 2021 and will include study sites in 15 countries. Developed with the EU-RESPONSE project, this trial has the capacity to implement Phase II and Phase III trials, and can evolve to include new study arms for hospitalized patients with moderate or severe COVID-19. 

The following infographic summarizes the design of the EU-SolidAct trial: 

SolidAct scheme

 

To learn more about how to propose a new study arm in the EU-SolidAct trial click here.

The DisCoVeRy trial was developed as an “add on” trial to the WHO Solidarity trial and initiated in France. Within the framework of the EU-RESPONSE project, DisCoVeRy was able to expand geographically, with the ambition of including 13 countries across Europe, and has evolved to include new study arms. The trial has assessed hydroxichloroquine, lopinavir/ritonavir with and without interferon β-1a and remdesivir.

The trial is currently as follows:

DISCOVERY scheme

 

To learn more about how to propose a new study arm in the DisCoVeRy trial click here. 

ECRAID-PRIME will be a first-of-its-kind European Adaptive Platform Trial on COVID-19 therapeutics in the primary care setting. It will build on the successful experience of past European platform trials in primary care networks across Europe, and the ongoing COVID-19 PRINCIPLE trial in the UK. The platform will use response adaptive randomization to ensure that the safety and efficacy of treatments can be assessed in the timeliest manner. It will focus on early phase trials for therapeutics that can be administered in the primary care setting, and will help to identify therapeutics that can progress to Phase III evaluation. EU funding for ECRAID PRIME depends on the finalisation of the ongoing grant preparation and final signature of the Grant Agreement.