Coronavirus disease 2019 (COVID-19) caused by infection with SARS coronavirus 2 (SARS-CoV-2) has reached pandemic proportions with more than 7 million people infected and 0.4 million people killed worldwide. Death rates are accentuated by cardiovascular comorbidities and arrhythmias leading to unexpected major cardiovascular events. Being able to identify COVID-19 patients at risk of developing cardiovascular events leading to death would allow improving surveillance and care. Currently, there is no accurate method to predict outcome of COVID-19patients. COVIRNA is a patient-centered Innovation Action aiming to satisfy this urgent and unmet need. COVIRNAwill complete and deploy a prognostic system based on cardiovascular biomarkers of COVID-19 clinical outcomescombined with digital tools and artificial intelligence analytics (i.e. prediction model). Complementary expertise of 15EU partners from the healthcare sector, academia, association and industry will allow conducting a large retrospective study on existing cohorts of COVID-19 patients. By upscaling the already validated and patented research use onlyFIMICS panel of cardiac-enriched long noncoding RNA biomarkers into an in-vitro diagnostic test (COVIRNA)adapted to COVID-19 patients, the project will quickly deliver a minimally-invasive, simple yet robust and affordable prognosis tool that can be used in the context of the current COVID-19 crisis as well as in further major health issues. By tackling the cardiovascular complications in COVID-19, known to contribute significantly to mortality, the project outputs are expected to have a major impact on the pandemic outcomes. The COVIRNA test will be CE-marked and prepared for commercialization, allowing to risk stratify patients, adapt therapies and to inform drug design.
Objectives and Methodology
The overall goal of the COVIRNA project is to generate a diagnostic test based on cardiovascular RNA biomarkers highly predictive of the clinical outcomes of COVID-19 patients and to enable its rapid market uptake with the aim to improve individualised surveillance, care and follow-up of these patients in the context of the current pandemic.
At the technological and research levels:
- To build a biobank of 2,000 blood samples from existing cohorts of COVID-19 patients throughout Europe to perform a retrospective multicentre international study;
- To achieve biomarker qualification and select a subset of highly specific lncRNAs predictive of COVID-19 clinical outcome using bioinformatics, artificial intelligence (AI) and biostatistics;
- To build a disease evolution prediction model based on selected lncRNAs and clinical data;
- To design a reliable, cost-efficient and easy to use in vitro diagnostic (IVD) test to predict COVID-19 clinical outcomes.
At the socio-economic and regulatory levels:
- To achieve CE marking of the innovative COVIRNA prognostic solution;
- To establish a strategic science-policy-business-society consultation to optimize the design of the diagnosis solution complying with end-users’ needs, cost-efficiency analysis requirements, current EU regulation and highest quality standards to enable and accelerate their uptake into clinical practice;
- To raise stakeholders’ awareness of advantages brought by the newly designed diagnostic solution as a valuable decision-support tool for healthcare professionals to deliver the best health outcome for the most vulnerable COVID-19 patients, through a tailored dissemination programme.
- Engage communities of stakeholders in sharing practical knowledge on the use of the novel medical technology.
Our role in COVIRNA
EHMA is involved in COVIRNA as leader of the dissemination and communication workpackage. Our approach is to build input and support to raise awareness of the project, and to inform key stakeholders about its outputs and create tools and a culture that encourages the practical appropriation of results by the target groups.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No.
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