EUCTR2020-001321-31-ES进行中（未招募）1 期
Prospective, phase II, randomized, open-label, parallel group study to evaluate the efficacy of hydroxychloroquine together with baricitinib, imatinib or early lopinavir / ritonavir in patients with SARS Cov2 pneumonia (COVID-19 HUF) - COVID-19 HUF
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
- 165
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
- •i. Signed informed consent form
- •ii. =18 years
- •iii. Confirmed diagnosis Pneumonia Covid19 +
- •iv. ECOG functional state 0 or 1
- •v. Less than 7 days from onset of symptoms
- •saw. NO contraindication for medication
- •vii. ECG QT <0.4
- •viii. Adequate liver, kidney and hematological function (or within the safety range to use these drugs)
- •1. Absolute granulocyte count> 1.5 x 109 / L
- •2. Absolute platelet count> 100 x 109 / L
- •3. Hb> 10 g / dL
- •4. Cr <1.5 mg / dL or Clearance> 50mL / min
- •5. Bilirubin <3 ULN
- •6. AST / ALT = 2.5 times ULN
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 85
排除标准
- •i. No Covid confirmation
- •ii. No pneumonia
- •iii. Previous treatment with any of the study drugs
- •iv. Concomitant serious medical condition
- •2. IAM 6 months prior
- •3. Unstable Angina
- •4. Cardiomyopathy
- •5. Unstable Ventricular Arrhythmia
- •6. uncontrolled HTA
- •7. Uncontrolled psychotic disorders
- •8. Serious active infections
- •10. Active hepatitis
- •11. Neoplasia in active cancer treatment
- •v. Inability to take oral medication or malabsorption syndrome
- •vi. Inability to comply with study and follow-up procedures
- •vii. History of only relevant thromboembolic or hemorrhagic episodes in the last 6 months
- •viii. Contraindication to any study medication
- •ix. Pregnant women
研究者
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