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.