Status:
UNKNOWN
Efficacy of Nafamostat in Covid-19 Patients (RACONA Study)
Lead Sponsor:
University Hospital Padova
Collaborating Sponsors:
Yokohama City University
University of Zurich
Conditions:
COVID19
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
Brief Summary
RACONA is a prospective trial that will test the hypothesis that nafamostat can lower lung function deterioration and need for intensive care admission in COVID-19 patients. Design: Adult hospitalize...
Detailed Description
Purpose: SARS-Cov-2 enters the lung cells by binding to ACE-2 and activating the protease TMPRSS2, which, therefore, can be a target for antiviral treatment. Accordingly, TMPRSS2 inhibitors prevent SA...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT04352400
Start Date
June 4 2021
End Date
December 1 2024
Last Update
November 1 2023
Active Locations (1)
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1
Azienda Ospedale Università di Padova
Padua, Italy, 35128