EUCTR2020-001307-16-ES进行中（未招募）1 期
Efficacy and Safety of corticoids in patients with adult respiratory distress syndrome (ARDS) secondary to COVID-19. - Steroids In Coronavirus (SIC)
Fundación para la Investigación Biomédica Hospital Ramón y Cajal0 个研究点目标入组 104 人开始时间: 2020年4月8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
- 104
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
- •1. Diagnosis of SARS-CoV-2 by testing the polymerase chain reaction performed on a respiratory sample;
- •2. Pneumonia confirmed by radiological imaging test;
- •3. ARDS Criteria:
- •(i) bilateral infiltrates;
- •(ii) PO2/FiO2 <300 mmHg; And
- •(iii) reasonable clinical exclusion of heart cause (requires all).
- •4. Verbal consent of the patient.
- •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 39
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •1. Age <18 years;
- •2. Less than 5 days from the onset of symptoms to randomization;
- •3. Pregnancy;
- •4. Hypersensitivity or known allergy to methylprednisolone;
- •5. Bacterial infection: not drained abscess, intravascular infection, bacterial pneumonia, septic shock, disseminated fungal infection;
- •6. Participation in another trial in the previous 30 days;
- •7. Acquired immunodeficiency syndrome;
- •8. Previous use of corticosteroids (cumulative dose of prednisone [or equivalent] of more than 300 mg in the last 21 days; or more than 15 mg/day in the last 7 days before randomization);
- •9. Cytotoxic treatment in the last 3 weeks;
- •10. Known or suspected adrenal insufficiency;
- •11. Lung or bone marrow transplant;
- •12. Severe liver disease.
研究者
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