Efficacy of Nafamostat in Covid-19 Patients (RACONA Study) (RACONA)

This is an interventional treatment trial for COVID19 focused on measuring Nafamostat, proteases, TMPRSS2, covid-19, coronavirus Read More

Inclusion Criteria:

• Hospitalized, COVID-19 positive, between 18 and ≤ 85 years of age;
• Signed Inform Consent Form;
• Body temperature > 37.3 ℃;
• Oxygenation criterion (any of the following): i) Oxygen saturation ≤94% on Room Air; ii) PaO2/FiO2 ratio ≤300 mmHg but > 100 mmHg, if patient on supplemental oxygen; iii) SpO2/FiO2<200 if no arterial blood gas available;
• Respiratory rate (RR) ≥ 25 beats/min.

Exclusion Criteria:

• Pregnant or lactating females;
• Unwillingness or inability to complete the study.
• Rapidly deteriorating clinical condition or low likelihood to complete the study according to the investigator;
• eGFR < 30 ml/min/m2 assessed with CKD EPI formula;
• Current or chronic history of liver disease (Child Pugh score ≥ 10), or known hepatic or biliary abnormalities;
• Participation in a clinical trial with an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer);
• Patients requiring high doses of loop diuretics (i.e. > 240 mg furosemide daily) with significant intravascular volume depletion, as assessed clinically;
• History of allergy;
• History of sensitivity to heparin or heparin-induced thrombocytopenia;
• Unstable hemodynamics in the preceding 4 hours (SBP < 90 mmHg, and/or vasoactive agents required);
• Hemoglobin < 7 at time of drug infusion. Transfusion is allowed to increase hemoglobin levels before entry into the study;
• Malignancy or any other condition for which estimated 6-month mortality >50%;
• Arterial blood pH less than 7.2;
• Known evidence of chronic interstitial infiltration at imaging;
• Known hospitalization within the past six months for respiratory failure (PaCO2 > 50 mmHg or PaO2 < 55 mmHg, or oxygen saturation <88% on FiO2 = 0.21);
• Known chronic vascular disease resulting in severe exercise restriction (i.e. unable to perform household duties);
• Known secondary polycythemia, severe pulmonary hypertension, or ventilator dependency;
• Known vasculitis with diffuse alveolar hemorrhage;.
• Pre-existing renal failure on hemodialysis or peritoneal dialysis requiring renal replacement therapy;
• Extracorporeal membrane oxygenation (ECMO);
• Immunosuppressive treatment;
• Patient in trials for COVID-19 within 30 days before;
• Unstable hemodynamics in the preceding 4 hours (MAP ≤ 65 mmHg, or SAP < 90 mmHg, DAP < 60 mmHg, and vasoactive agents required);
• Hyperkalemia , i.e. serum K+ levels > 5.0 mEq/L;
• Severe active bleeding;
• Any other uncontrolled comorbidities that increase the risks associated with the study drug administration, as assessed by the medical expert team.