As of writing (10 September 2021), there have been over 220 million worldwide cases of the coronavirus disease 2019 (COVID-19), with 64,395,450 of those cases being reported in Europe. More than 3.6 million hospitalizations of COVID-19-infected patients have occurred in Europe alone since the outbreak last year, and about 9.6 million hospitalizations worldwide.

An average 14% of those patients with mild or moderate illnesses in Europe, and over 21% in the US, develop severe symptoms are eventually admitted to the Intensive Care Unit (ICU). The most common treatment of patients in the first two stages of the illness, such as remdesivir and antibody therapies, have neither shown the desired effect nor prevented the progression of the disease to severe and critical stages of the illness.

COVID-19 is a worldwide health concern. Mild to moderate cases account for ca. 80% of laboratory-confirmed patients, taking up the majority of COVID-19 patients admitted to hospitals all over Europe. Various studies have shown that patients with underlying comorbidities, such as advanced age (>65 years), cardiovascular disease, obesity, or diabetes, are at a higher risk of progressing to severe (15%) or critical (5%) stages of COVID-19.

Approximately 50% of hospitalized patients have comorbidities and hence are at higher risk of progressing to severe illness. SARS-CoC-2-positive patients having an oxygen saturation ≤ 94% and a breathing frequency per minute ≥ 20 will be included into the study. A study published in October 2020 suggests that the pathological manifestations leading to severe COVID-19 have been recently considered as vascular leak-age, inflammatory reactions, anticoagulation imbalance, and endothelial dysfunction. Targeting these pathological manifestations, FX06 aims to prevent the progression to severe COVID-19 and to improve patient out-come.