Clinical Trial

ARDS is a critical medical challenge without drug-based treatment options and often develops as a result of an unbalanced immune response caused by viral or bacterial infections, severe trauma, major surgery, or blood transfusions. In ARDS patients, the gas exchange is impaired due to dysfunctional capillaries, damaged alveoli, and fluid accumulation in the lungs. Studies report 7-23 cases of ARDS per 100,000 inhabitants in Europe each year. ARDS accounts for around 10% of all ICU admissions and around 20% of mechanically ventilated patients, with in-hospital mortality rates of up to 45%. Despite decades of research, no effective drug treatment has yet been developed, which emphasises the urgent need for innovative therapeutic approaches.

IXION 2.0 – Our clinical study

The IXION 2.0 study is an exploratory, randomised, placebo-controlled, double-blind, parallel phase II clinical trial. IXION 2.0 is being conducted in five European countries (France, Germany, Lithuania, Romania and Spain) and is open to patients of all genders and all ethnicities, ensuring a diverse study population representative for all European citizens. It is embedded in the EU-funded COVend project – a multidisciplinary initiative that brings together clinicians, biochemists, data scientists, and economists to gain a comprehensive understanding of ARDS and identify effective treatment strategies for real-world scenarios.

Clinical studies in ARDS have been notoriously unsuccessful. The results of the IXION 2.0 study will, therefore, include patient-relevant outcomes and utilise an exploratory molecular analysis of the proteins, lipids, and metabolites in the blood of the study participants (so-called multi-omic analysis) to identify subtle pathophysiological differences between patient groups. AI tools complement the data and enable an individualised clinical practice to select patients who will benefit from the therapy and monitor its efficacy based on unique biomarkers. Advanced cell biology methods using endothelial cell lines will uncover the molecular mechanism of FX06, contributing to knowledge-based trust and transparency in medicine and potentially paving the way for further life-saving applications. In addition to scientific research, the COVend consortium is also dedicated to the evaluation of FX06 from a health economic perspective. By developing a dynamic model, the socio-economic benefits and cost-effectiveness of FX06 will be assessed to ensure its practical feasibility in healthcare.

FX06 – innovative compound against capillary leak

FX06, a naturally occurring fibrin fragment in the human body, introduces a novel mechanism of action targeting the molecular origin of ARDS. It binds to vascular endothelial cadherin, a molecule at the surface of the endothelial cells lining the inside of capillaries. FX06 has an anti-inflammatory and capillary-protecting effect and can thus counteract the vicious spiral that progressively worsens the patient’s condition. Based on animal models, FX06 has considerable therapeutic potential for all diseases and pathological conditions associated with increased vascular permeability (Gröger et al. 2009 PLoS ONE, Bergt et al. 2016 Crit Care Med). FX06 binds to vascular endothelial (VE)-cadherin, preventing the transmigration of leukocytes.

IXION 2.0 is upstream to major goals of the COVend project

The IXION study has been registered under EudraCT number 2021-005059-35

FAQ

Clinical study is a type of research that involves volunteers (participants of the study) and aims to add knowledge to medical field. It may involve development of new treatments, drugs or preventive methods and aim to see what effect do they have on people. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. AI-Mind study is an observational study. 

You may find more  information on clinical studies here:
Learn about Clinical Trials

The study duration for individual patients will be maximally 28 days (plus up to 5 days screening period) for the main study period, with a follow up telephone call at day 60.

The health of millions of people has been improved because of advances in medical care, made possible by clinical trial participants. People choose to participate in clinical trials for a variety of reasons, including the chance to play a more active role in their own health care, gain access to new medical treatments before they are available to the wider public, and help others by contributing to the future of medical science.

All the tests and procedures in the study are considered safe and none of them is invasive, except for the blood samples. There are no known or anticipated risks to you if you join the study. 

Yes, patients in the COVend study will be treated with FX06 twice a day. 

FX06 is a naturally occurring peptide and is the component used in the COVend study to stop the progression of COVID-19. It has been found to have a benign safety profile in safety pharmacology and toxicology studies, and good tolerability upon administration. 

All clinical trials have rules about who can and cannot participate. These rules are called “eligibility criteria” but may also be referred to as inclusion/exclusion criteria. The criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. The eligibility criteria define the patient population that is being studied and are designed to protect the safety of participants in the trial. Because of the criteria, not everyone will qualify to participate in the trial.

Participation in the study is voluntary, you can withdraw at any time.

All the information collected from participants during the COVend study will be kept confidential, securely encrypted and not used for purposes other than the COVend project. 

The COVend study has been approved by the National Committees for Medical and Health Research Ethics and we put every effort to ensure that you’re comfortable with your participation. However, if you have any concerns or complaints about the study, please feel free to contact project coordinator at: [email protected]

FX06 placebo will be administered over a 5-day Period. Patients will receive either 2 boluses of FX06 or a placebo twice daily and will be observed until day 28.

The study duration for individual patients will be maximally 28 days (plus up to 2 days of Screening period) for the main study period plus a follow up telephone call on day 60.

263 hospitalised patients with mild to moderate ARDS will be recruited for this study. Patients will be included according to inclusion and exclusion criteria.