Although the Coronavirus disease 2019 (COVID-19) has shaped our daily life for over a year, there is no causal therapy currently available. Still today, the therapy is limited to symptom control. Consequently, great expectations are placed on the various vaccines.
However, the public often forgets that vaccines can lose their effectiveness due to viral mutations, such as the prominent Delta variant or lately the Omikron variant. It is therefore essential to develop drugs that can reliably prevent severe courses of COVID-19. To date, there are no generally effective therapies for COVID-19 nor antivirals against the virus that causes the disease, SARS-CoV-2. Although, some treatments have shown some benefits in certain subpopulations of patients or for certain end points.
Researchers and manufacturers are conducting large-scale clinical trials to evaluate various therapies for COVID-19. Due to the varying stages of the disease, it is likely that each stage needs a different therapeutic approach: While in the very early phases antiviral drugs and antibodies might be best for fighting the virus, advanced stages are characterized more by the host response. Here, drugs are needed that interfere with the host response that is directly or indirectly induced by the virus.
We have named our COVend study IXION, apropos of the Greek king tied to a sun wheel, which looks similar to the coronavirus structure and represents FX06’s potential to prevent the disease progression in hospitalised non-intubated COVID-19 patients.
The clinical trial is at the heart of the work in COVend, to deliver FX06 as a viable therapy against COVID-19. These studies ensure that our medical research is effective and safe, and relies entirely on patients and healthy volunteers.
As the underlying pathological disease process of COVID-19 is characterized by a continuous progression of endothelial injury, FX06, a protective substance against endothelial damage, is expected to prevent the disease from progressing from a moderate to a severe stage. To prove this hypothesis – which is well based on experimental animal data – we propose a controlled, randomised ph II/III study in approximately 300 patients with mild to moderate COVID-19.
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.
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.
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]