EUCTR2020-002570-27-IT进行中（未招募）1 期
A Randomized Clinical Trial of Nafamostat: A Potent Transmembrane Protease Serine 2 (TMPRSS2) Inhibitor for the Treatment of Covid-19 - RACONA Study
Dipartimento di Medicina-DIMED, università di Padova0 个研究点目标入组 256 人开始时间: 2021年6月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 256
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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