A Randomized Clinical Trial of Nafamostat for the Treatment of Covid-19

Phase 1

• Conditions: Covid-19 (Coronavirus disease 2019) caused by SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2, SARS-CoV-2); MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-002570-27-IT
• Lead Sponsor: Dipartimento di Medicina-DIMED, università di Padova

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-04
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

We will include patients of both sexes if the following criteria apply:
•Hospitalized, COVID-19 positive, between 18 and 85 years of age;
•Signed Inform Consent Form;
•Body temperature > 37.3°C;
•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 is available;
•Respiratory rate (RR) > 25 beats/min
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 256
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

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 (MAP < 65 mmHg, or SAP < 90 mmHg, DAP < 60 mmHg, and/or vasoactive agents required);
•Hemoglobin < 7 g/dL 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/or vasoactive agents required);
•Hyperkalemia , i.e. serum K+ levels > 5.0 mmol/L, or hyponatremia, i.e. serum Na+ levels < 130 mmol/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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified