Periodic Reporting for period 1 - EU-RESPONSE (European Research and Preparedness Network for Pandemics and Emerging Infectious Diseases)
Okres sprawozdawczy: 2020-07-01 do 2021-12-31
In the context of the COVID-19 pandemic, the objective of EU-RESPONSE was to expand the DisCoVeRy trial, designed as a multi-arm adaptative repurposing trial, first launched in France, to many other European countries with appropriate support in terms of multinational funding, and in terms of trial management capacity. This was to enable rapid evaluation of repurposed and non-repurposed drugs against COVID-19, and to build a network of clinical trials.
Secondly, based on the experience acquired from DisCoVeRy, EU-RESPONSE aim was to build a multinational, European multi-arm COVID-19 Adaptive Platform Trial. The platform needs to have a strong governance to provide a modular trial framework for COVID-19 and other emerging infectious diseases enabling most, if not all, European hospitals to participate at their preferred level of commitment, to develop the network of sites within European and associated countries and to launch at least a trial.
The project also aims to collaborate with other COVID-19 and emerging infectious disease initiatives in Europe and beyond, through a shared workpackage with the EU-funded project RECOVER.
Secondly, based on the experience acquired from DisCoVeRy, EU-RESPONSE aim was to build a multinational, European multi-arm COVID-19 Adaptive Platform Trial. The platform needs to have a strong governance to provide a modular trial framework for COVID-19 and other emerging infectious diseases enabling most, if not all, European hospitals to participate at their preferred level of commitment, to develop the network of sites within European and associated countries and to launch at least a trial.
The project also aims to collaborate with other COVID-19 and emerging infectious disease initiatives in Europe and beyond, through a shared workpackage with the EU-funded project RECOVER.
The DisCoVeRy trial has evaluated the efficacy and safety of treatment with Remdesivir + standard of care to standard of care alone in hospitalized, COVID-19 patients. The treatment has shown no effect on clinical status at day 15, on hospital length of stay, nor mortality. The trial is now currently evaluating the safety and efficacy of the AZD-7442 monoclonal antibody cocktail in this same patient population. The study has now been extended to 45 sites in 6 different European countries and 1446 patients were included in the DisCoVeRy trial so far.
Discussions with stakeholders has led to the development and the submission through the VHP procedure of the Master protocol for the EU-SolidAct Adaptive Platform Trial. The teams of the various roles, such as sponsor, data management and analysis, were selected. A first IMP specific trial was submitted to competent authorities across 14 states and was launched in spring 2021, 225 patients have been randomised so far.
A Trial Coordination Board (TCB) that brings together key stakeholders of the COVID-19 adaptive platform trials has been established, as well as the Joint Access Advisory Mechanism (JAAM) that assesses candidate compounds that could become new trial arms.
Discussions with stakeholders has led to the development and the submission through the VHP procedure of the Master protocol for the EU-SolidAct Adaptive Platform Trial. The teams of the various roles, such as sponsor, data management and analysis, were selected. A first IMP specific trial was submitted to competent authorities across 14 states and was launched in spring 2021, 225 patients have been randomised so far.
A Trial Coordination Board (TCB) that brings together key stakeholders of the COVID-19 adaptive platform trials has been established, as well as the Joint Access Advisory Mechanism (JAAM) that assesses candidate compounds that could become new trial arms.
There are several expected achievements/results for DisCoVeRy, such as continuing extending the trial to the rest of Europe and finish recruiting patients while harmonizing virological analyses across laboratories in Europe. The results of the trial will be published to help evaluate medicines for COVID-19 and the DisCoVeRy biobank can support other research projects and ancillary studies.
The expected impact for EU-SolidAct Adaptive Platform Trial is to become a recognized sustainable European network in the field of clinical studies of emerging infectious diseases in hospitalized individuals.
The TCB has become a trusted platform for the exchange of scientific information and insights for public policy; facilitating networking and collaboration. The JAAM provides independent scientific advice for optimal selection of new study arms. They will continue to support COVID-19 research, and will set the precedent for future research programs.
The expected impact for EU-SolidAct Adaptive Platform Trial is to become a recognized sustainable European network in the field of clinical studies of emerging infectious diseases in hospitalized individuals.
The TCB has become a trusted platform for the exchange of scientific information and insights for public policy; facilitating networking and collaboration. The JAAM provides independent scientific advice for optimal selection of new study arms. They will continue to support COVID-19 research, and will set the precedent for future research programs.