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Objectives

 

The overarching aim of the COVend Research and Innovation Action is to deliver a new effective therapy against SARS-CoV-2 for the clinical management of COVID-19 disease during mild and moderate stages, including for the prevention of disease progression to severe illness. We aim to achieve this by testing a promising candidate, the peptide FX06, in a placebo-controlled, multi-national ph II/III study in moderate cases of COVID-19.

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/III placebo-controlled, multi-centre clinical study to provide data regarding the safety and efficacy of FX06 in the treatment of mild/moderate COVID-19;
  • Apply OMICs technologies to deeply characterise the molecular profiles in COVID-19 patients treated with FX06 versus placebo over time;
  • 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 (ECs) 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 moderate COVID-19;
  • Evaluate FX06 from a health economic perspective and identify relevant policies and barriers affecting the feasibility of its implementation.

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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