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Objectives

The overarching aim of the COVend Research and Innovation Action is to deliver a new effective therapy against endothelial damage in ARDS for the clinical management of COVID-19 and other diseases during mild and moderate stages, including for the prevention of disease progression to severe illness. This will be achieved by testing a promising candidate, the peptide FX06, in a placebo-controlled, multi-national ph II study in mild and moderate cases of ARDS induced by COVID-19 and of other aetiologies. FX06 does not belong to any known drug class, and targets the endothelium, which is affected directly or indirectly by the host response to pathogens and tissue damage.

The specific objectives of COVend are:​

  • Prepare the therapeutic candidate FX06 for the clinical trial and discuss in parallel the study design and the suitability of endpoints for market authorisation;
  • Conduct the ph II placebo-controlled, multi-centre clinical study with 263 patients in five European countries, to provide data regarding the safety and efficacy of FX06 in the treatment of mild/moderate ARDS induced by COVID-19 or of other aetiologies;
  • Apply omics technologies (proteomics, metabolomics and lipidomics) to gain longitudinal molecular profiles of ARDS patients treated with FX06 versus placebo;
  • Investigate the influence of COVID-19-triggered cytokines on apoptosis/necrosis and immunological activation as well as on the transendothelial permeability of pulmonary endothelial cells under steady-state and flow/shear stress conditions;
  • Enable and carry out data analytics and modelling towards personalised decision support for FX06 in the treatment of mild to moderate ARDS related to COVID-19 and other aetiologies;
  • Evaluate FX06 from a health economic perspective and identify relevant policies and barriers affecting feasibility of its implementation.

COVend ambition

The overall ambition of the COvend project is to reduce the number of ARDS patients with and without COVID-19 in hospitals and lower the burden on patients and their families, clinical staff and the healthcare sector. Specifically, the COVend consortium aims enrich the current portfolio of SARS-CoV-2 /COVID-19 and ARDS drug candidates with clinical testing of FX06 as a novel compound targeting the host response. It also plans to develop precision medicine approaches using innovative immune-biomarker profiling, endothelial cells assessment methods and AI-driven decision support models, for the clinical management of COVID-19 and ARDS, including for the prevention of disease progression to severe illness and hospitalisation.

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HADEA). Neither the European Union nor the granting authority can be held responsible for them.

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