NEWS & EVENTS
June 20th 2024
EU-RESPONSE second face-to-face consortium meeting
The EU-RESPONSE consortium held its second face-to-face consortium meeting in Madrid on 19-20 June, 2024. The event brought together around 50 attendees, including project partners, the chair of the EU-RESPONSE Scientific and Ethics Advisory Board, and other invited external experts. Participants engaged in productive discussions about the project's progress, achievements, and upcoming steps, highlighting the [...]
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April 25th 2024
Coordination of COVID-19 platform trials in Europe
Coordination of COVID-19 platform trials in Europe To ensure optimal coordination of the EU-funded COVID-19 platform trials, a double coordination mechanism was established. It included the Trial Coordination Board (TCB) to promote the dialogue between investigators and relevant public health stakeholders and the Joint Access Advisory Mechanism (JAAM) to streamline access of new intervention arms [...]
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February 15th 2024
DisCoVery publishes a letter on Tixagevimab-cilgavimab (AZD7442) for the treatment of patients hospitalized with COVID-19 (DisCoVeRy): A phase 3, randomized, double-blind, placebo-controlled trial
Tixagevimab-cilgavimab (AZD7442) for the treatment of patients hospitalized with COVID-19 (DisCoVeRy): A phase 3, randomized, double-blind, placebo-controlled trial. There is ongoing need to urgently address the mAb treatment gap, particularly for immunocompromised patients. The unmet need is further highlighted by the DisCoVeRy Phase 3, adaptive, multicenter European, randomized, double-blind, superiority trial that evaluated the efficacy [...]
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December 13th 2023
Cardiac Adverse Events and Remdesivir in Hospitalized Patients with Coronavirus Disease 2019 (COVID-19): A Post Hoc Safety Analysis of the Randomized DisCoVeRy Trial
Cardiac Adverse Events and Remdesivir in Hospitalized Patients with Coronavirus Disease 2019 (COVID-19): A Post Hoc Safety Analysis of the Randomized DisCoVeRy Trial The study aimed to evaluate the cardiac adverse events (AEs) in hospitalized patients with Coronavirus Disease 2019 (COVID-19) receiving remdesivir plus standard of care (SoC) compared to SoC alone (control), as an [...]
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October 11th 2023
DisCoVery publishes an article on association between SARS-CoV-2 viral kinetics and clinical score evolution in hospitalized patients
The role of antiviral treatment in COVID-19 hospitalized patients remains controversial. In this study, we analyzed nasopharyngeal viral load and the clinical score of patients (as measured by the National Early Warning Score 2 (NEWS-2)) in the DisCoVeRy trial, where 664 patients were randomized to either standard of care (SoC) or SoC + remdesivir. We [...]
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September 15th 2023
EU-RESPONSE supports a global meta-analysis on JAK inhibitors in hospitalized COVID-19 patients
Several trial consortia, including EU RESPONSE, have investigated JAK inhibitors (such as baricitinib, ruxolitinib, and tofacitinib) for the treatment in patients hospitalized with COVID-19. However, these trials showed conflicting results, especially regarding specific subgroup of patients such as patients with co-morbidities. As part of EU RESPONSE’s effort to generate high-quality evidence for COVID-19 treatments, we [...]
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June 15th 2023
DisCoVery publishes an article on quality control in the context of the SARS-CoV 2 epidemic
Ensuring quality control in a COVID-19 clinical trial during the pandemic: The experience of the Inserm C20–15 DisCoVeRy study The study Sponsor is responsible for ensuring participants’ safety and reliability of the data collected, in particular through the monitoring carried out in the investigating centers. This article presents the experience of quality control assurance in [...]
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June 5th 2023
DisCoVery publishes an article on management of pharmacovigilance during the COVID-19 pandemic crisis
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 During a pandemic crisis, sponsors should educate and train investigators about the importance of the pharmacovigilance issues. •The assessment of the safety profile of the investigational medicinal drug is [...]
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May 15th 2023
EU-RESPONSE first face-to-face consortium meeting
EU-RESPONSE first face-to-face consortium meeting was succesfully held in Oslo on 11-12 May 2023, in presence of the chair of EU-RESPONSE Scientific and Ethics Advisory Board and other invited external experts. Around 60 people attended in person to discuss the project progress, acheivements and next steps.
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January 13th 2023
EU SolidAct publishes resuts on Baricitinib as a Treatment for Hospitalized COVID-19 Patients
EU SolidAct publishes resuts on Baricitinib as a Treatment for Hospitalized COVID-19 Patients The first drug tested on EU-SolidAct is baricitinib, a tablet approved for the treatment of rheumatoid arthritis, atopic dermatitis, and alopecia areata. Results of the Bari-SolidAct clinical trial, conducted in 14 European countries, have been published in Critical Care on January 10th [...]
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March 7th 2022
EU SolidAct continues, randomising only immunocompromised patients in the baricitinib trial
EU SolidAct continues, randomising only immunocompromised patients in the baricitinib trial Based on recent results from the Recovery trial showing a mortality benefit for baricitinib in severe COVID-19, EU SolidAct has decided to stop inclusion of immunocompetent participants to the baricitinib trial. However, as the safety and benefit of immunomodulators including baricitinib is still not [...]
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March 2nd 2022
remdesivir has a significant antiviral activity, reducing the amount of viral particles released by infected cells
An article published on 2 March in The Journal of Antimicrobial Chemotherapy, shows the effect of remdesivir on viral dynamics in COVID-19 hospitalized patients. The use of remdesivir has been associated to contradictory virological and clinical results in the past months. Here, we analyzed its effect on viral dynamics in the DisCoVeRy trial, where 665 [...]
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January 27th 2022
BerGenBio and Oslo University Hospital Announce the AXL Inhibitor Bemcentinib will be Studied in the EU Funded EU-SolidAct trial in Hospitalised COVID-19 Patients
Bergen, Norway and Oslo, Norway 27 January 2022 – BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs and Oslo University Hospital announced today the execution of a collaborative agreement to study the BerGenBio AXL inhibitor bemcentinib, in hospitalised COVID-19 patients. The EU-SolidAct trial - European [...]
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September 24th 2021
Remdesivir Ineffective in Patients Hospitalized With COVID-19 and the DisCoVeRy Trial Continues with a New Antiviral
The Discovery clinical trial was initially launched in France by Inserm in March 2020, to evaluate several possible treatments for COVID-19. Its European expansion was made possible by the EU-RESPONSE[1] project, funded by Europe. Interim analysis of the trial data had led to the recommendation to suspend the recruitment of remdesivir group patients for futility [...]
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June 28th 2021
Launch of European Covid-19 trials coordination module website
Launch of European Covid-19 trials coordination module website. The coordination module of the EU-funded projects RECOVER1 and EU-RESPONSE2 has launched its website https://covid19trials.eu/en. It centralises information for academics and industry on access to the three large Pan-European adaptive platform trials currently underway: DisCoVeRy, EU-SolidAct & REMAP-CAP. A coordinated Pan-European approach is essential for tackling the [...]
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May 28th 2021
EU SolidAct – a pan-European platform for pandemic research and preparedness
EU SolidAct - a pan-European platform for pandemic research and preparedness There is an urgent need for rapid and coordinated investigation of new candidate drugs during pandemics. EU-SolidAct is an Adaptive Platform Trial developed to evaluate drug interventions in hospitalized patients with COVID-19 and to facilitate a joint European response to future pandemics. The first [...]
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April 29th 2021
Inserm and AstraZeneca join forces to test the efficacy of monoclonal antibody combination AZD7442 on Covid-19 in the European DisCoVeRy trial
April 29, 2021 – A long-acting antibody (LAAB) combination developed by AstraZeneca is to be evaluated in DisCoVeRy, the Inserm-coordinated European trial aimed at finding a treatment for COVID-19. It is planned to enroll 1240 patients across Europe in this Phase III clinical trial. With its wealth of experience in the domain of targeted therapies [...]
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October 20th 2020
Launch of the EU-RESPONSE project
The EU-RESPONSE Kick-off meeting took place on October 20th 2020 via videoconference. This meeting gathered the whole EU-RESPONSE consortium to present and discuss the planned work programme with the participation of European Commission representatives and external invitees.
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July 1st 2020
DisCoVeRy trial in practice
The DisCoVeRy clinical trial is an adaptive, randomized, open-label clinical trial, add-on of the Solidarity trial, that aims to evaluate the safety and efficacy of four antiviral therapeutic strategies as compared with standard of care. Patients are hospitalized in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe with COVID-19 [...]
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