Rezultaty
This report will include but is not limited to key recommendations to implement the highlevel strategy defined by the TCB development of new platforms major amendments to existing platforms introduction of new therapeutic domains introduction of new arms development of platforms for prevention or vaccines design of interventional trials based on observational studies expansion to new countries including capacity building for interested sites site selection etc The report will describe the framework that will allow complementarity between trials with regard to the implementation of the highlevel strategy This report will also include the detailed plan on data harmonization between trials to allow common analysis of core data sets
Plan for coordination and collaboration with other SARS-COV-2 projects: update 1First update of D13
SOPs to standardise and harmonise diagnostic test protocolsSOPs to standardise and harmonise diagnostic test protocols for detection of the SARS-CoV-2 and/or exclusion of other respiratory viral and bacterial pathogens.
Final report on the readiness of the networksReport on the additional qualitative work on the readiness of the networks
Protocol for healthcare professionals surveyUnderstanding healthcare worker views on the management of the COVID-19 pandemic can inform hospital strategies for implementing IPC guidelines, inform communication strategies and can inform strategies to protect healthcare worker physical and psychological health.
1-Reports on the coordinated development and operational management of the European COVID-19 Adaptive Platform TrialsThis report will include, but is not limited to key recommendations to implement the high-level strategy defined by the TCB - development of new platforms, major amendments to existing platforms, introduction of new therapeutic domains, introduction of new arms, development of platforms for prevention or vaccines, design of interventional trials based on observational studies, expansion to new countries including capacity building for interested sites, site selection etc. The report will describe the framework that will allow complementarity between trials with regard to the implementation of the high-level strategy. This report will also include the detailed plan on data harmonization between trials to allow common analysis of core data sets.
2-Report on the strategic vision and deployment of the European COVID-19 Adaptive Platform TrialsThis report will include but is not limited to COVID19 international clinical research benchmarking and landscape analysis clinical research gaps for Europe recommendations on priorities in terms of platform trials therapeutic domains and arms It will also include a report on lessonslearnt from OCToPUs
First study report of finalized analysis in one treatment domainStudy updates and summaries
Regular study updates will allow to keep all partners informed about study progress Dates of publication cannot be specified as patient enrollment depends on the evolution of the pandemic
Plan for coordination and collaboration with other SARS-COV-2 projects: update 2Second update of D13
UK approved protocol for adapted PRUDENCE trialRECOVER will seek rapid UK approval of the protocol governing the adapted PRUDENCE trial as originally developed in the VALUEDx project
Healthcare professionals survey reportInterview approaches will be pragmatic and adapted to consider the immediate needs of healthcare professionals and to minimise burden.
1-Report on the strategic vision and deployment of the European COVID-19 Adaptive Platform TrialsThis report will include, but is not limited to COVID-19 international clinical research benchmarking and landscape analysis, clinical research gaps for Europe, recommendations on priorities in terms of platform trials, therapeutic domains and arms. It will also include a report on lessons-learnt from OCToPUs.
Plan for coordination and collaboration with other SARS-COV-2 projectsReport to include plan for regular meetings to update on each other's progress, concrete plan on use of common protocols and to ensure harmonization of data collection and coordinated modelling, establishment of inter-project working groups, plan on integration of social sciences capacities and sharing research findings on the dedicated platform (Health Policy Platform/research for policy action).
Results of etiologic diagnosisResults of etiologic diagnosis on the samples from patients included in the clinical trials on the SARS-CoV-2 in WP2 and WP3.
Final study reportFeasibility questionnaire
To facilitate the site selection process, a feasibility questionnaire will be sent that aims to collect study-specific information e.g. on in-house methods and possibilities to implement protocols and methods to detect SARS-COV-2.
Validation report on PCR based testValidation report on ready-to-use in-house PCR based test to be used in the clinical trial.
Approved protocol for the observational studyThis protocol for a prospective, non-randomized observational study of CA-ARTI in primary care will include capability to register patients with CA-ARTI in primary care in up to 20 countries, capturing data about the presentation, management, risk factors and (reasons for) suspicion for SARS-CoV-2, treatment, routine investigations performed, outcome of tests, taking a throat and/or nasal swab for research purposes, and capturing clinical outcomes and patient and HCP perceptions.
Monthly interim findings from social science related activitiesIn order to rapidly generate evidence for public health and other decision makers, RECOVER will include a brief survey for patients and healthcare workers. Information will be rapidly processed and interim findings fed back to decision makers.
Policy brief reporting outcomes from the public surveyInterim reports will help guide communication strategies and clinical research planning at local and national levels
Communication outputsWe will share our (preliminary) results with public health authorities, policy makers and healthcare workers via regular policy briefs and healthcare briefs, summarizing our findings in a concise manner. There is a wealth of other research response efforts being implemented by the wider European infectious diseases research response community. Many of our partners working in Europe, but also in regions outside of Europe (e.g. Africa and Asia) have informed us of their efforts and offered linking their efforts to those conducted in RECOVER. We will reach out to patient organisations such as the International Alliance of Patients’ Organisations (IAPO and European Lung Foundation (ELF) to assess their information needs and how we can best serve these out of RECOVER. RECOVER will target the media with press releases at important time points and milestones. RECOVER's communication activities include the design of a visual identity, online presence (website, social media...), open access publications, news updates, infographics and brochures.
Study protocol MERMAIDS 2.0For Phase II, we will adapt the existing MERMAIDS-ARI protocol (part I) to capture additional aspects relevant to SARS-CoV-2 infections, collect more and targeted biological sampling of confirmed SARS-CoV-2 infections needed for WP5 and WP6, and to enroll children (non-eligible in part I).
Second overall study reportReport on tools, methodologies and sustainability model for Adaptive Platform Trial design and management, including blueprint for the creation and management of Adaptive Platform Trials in other disease areas beyond COVID-19
This report will include but is not limited to tools for the design of platform trials including statistical methods master protocol template selection of outcome measures and endpoints etc tools for the management of platform trials including sponsorship IP pharmacovigilance data management data sharing cost and business model etc
Protocols for collection and transport of specimensThis deliverable includes sampling SOPs with details on the choice of samples and sampling collection time points that should be collected in line with the study objectives and SOPs with detailed instructions on sample processing locally, storage and transfer of samples to the central laboratory.
Final study report on the social science output
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