EUCTR2020-002114-40-FR进行中（未招募）1 期
intedanib for the treatment of SARS-Cov-2 induced pulmonary fibrosis - NINTECOR
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- •Age > 18 years and <89 years
- •-History of hospitalization for COVID-19 infection documented with positive PCR or positive serology in the previous 2 to 6 months
- •-Lung opacities on HRCT involving more than 10% of the lung volume, with fibrotic features
- •-DLCO= 70% predicted
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •-Pre-existing lung disorder with abnormal HRCT (including COPD, lung cancer, or pulmonary fibrosis)
- •-Recent surgery with wound healing in progress
- •-Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment).
- •-Significant pulmonary arterial hypertension (PAH) defined by any of the following:
- •a. Previous clinical or echocardiographic evidence of significant right heart failure
- •b. History of right heart catheterisation showing a cardiac index =2 L/min/m²
- •c. PAH requiring parenteral therapy with epoprostenol/treprostinil.
- •-History of cardiovascular diseases, any of the following:
- •a. Severe hypertension, uncontrolled under treatment (=160/100 mmHg), within 6 months of Visit 1
- •b. Myocardial infarction within 6 months of Visit 1
- •c. Unstable cardiac angina within 6 months of Visit 1.
- •-Bleeding risk, any of the following:
- •a. Known genetic predisposition to bleeding.
- •b. Patients who require
- •i. Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin)
- •ii. High dose antiplatelet therapy.
- •-Pregnancy or lactation (women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using at least two methods of birth control from the date of consent to three months after the end of the patient study participation).
- •-Alcohol or drug abuse which in the opinion of the treating physician would interfere with treatment.
- •-Ongoing or past antifibrotic treatment with pirfenidone or nintedanib
- •-Hypersensitivity to nintedanib, peanut or soya or to any of the excipients of the specialty Ofev®
- •-Patients not able to understand and follow study procedures including completion of self-administered questionnaires without help.
- •-No written informed consent from the patient
- •-Absence of affiliation to the French social security
- •-Participation in another interventional research
研究者
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