EUCTR2020-001765-37-ES进行中（未招募）1 期
Pragmatic clinical trial to evaluate the efficacy of hydroxychloroquine in the treatment of COVID-19 infection in two cohorts: patients with oncohaematological disease and SARS-CoV-2 positive without radiological alteration and sars-cov-2 positive professionals without radiological alteration
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 103
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
- •Patient Cohort
- •1) Patients diagnosed with onco-haematological disease
- •2) Age: over 18 years old.
- •3) ECOG performance status < 2 (Karnofsky>60%)
- •4) Life expectancy > 3 months for the neoplastic disease.
- •5) Patients with laboratory confirmed Covid-19 diagnosis (PCR)
- •6) Patients with clinical signs compatible with Covid-19: fever, cough, dyspnea.
- •7) Patients should have chest radiological imaging (plaque or CT scan) with no affectation compatible with Covid-19.
- •8) NIT-1-2 patients
- •9) Mild functional alteration of organs, defined as:
- •- Calculated creatinine clearance > 30 ml/min
- •- Bilirubin < 25 µmol/l (1.5 mg/dl)
- •- AST/ALT < 2.5 times upper limit of the centre's normality
- •- Alkaline phosphatase < 2.5 times upper limit of centre's normality
- •- Normal spinal function: Hematology: neutrophils > 1.0 x 109/l, lymphocytes > 0.5 x 109/l, platelets > 75 x 109/l, hemoglobin > 8 g/100ml.
- •-PT and PTT: normal
- •10) To give informed consent in accordance with current legal regulations.
- •Professional Cohort
- •1) Age: over 18 years old.
- •2) Diagnosis Covid-19 confirmed by laboratory (PCR)
- •3) They must have a chest X-ray image (plate or CT) with no Covid-19 compatible affectation.
- •4) Adequate organic function, defined as:
- •- Calculated creatinine clearance > 30 ml/min.
- •- Bilirubin < 25 µmol/l (1.5 mg/dl)
- •- AST/ALT < 2.5 times upper limit of the centre's normality
- •- Alkaline phosphatase < 2.5 times upper limit of centre's normality
- •-Normal spinal function: Hematology: neutrophils > 1.0 x 109/l, lymphocytes > 0.5 x 109/l, platelets > 75 x 109/l, hemoglobin > 8 g/100ml.
- •- PT and PTT: normal
- •5) To give informed consent in accordance with current legal regulations.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 43
排除标准
- •Patient cohort and professional cohort
- •? Uncontrolled intercurrent disease including infections other than CoVID19, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric or social disorder that may limit study requirements
- •? To be receiving any other drug or product under study
- •? Allergy to one or more of the medications in the trial
- •? Chronic concomitant immunosuppressive medication
研究者
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