EUCTR2021-001028-16-ES进行中（未招募）1 期
DEXamethasone EARLY administration in hospitalized patients with Covid-19 pneumonia and high risk of developing acute respiratory distress syndrome - EARLY-DEX Covid-19
Fundación para la Investigación e Innovación Biomédica (FIIB) del Hospital Universitario Infanta Leonor y Hospital Unive0 个研究点目标入组 126 人开始时间: 2021年9月1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
- 126
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
- •Hospitalized patients with Covid-19 pneumonia who do not require oxygen therapy on admission associated with at least two of the three following factors related with severe Covid-19: lactate dehydrogenase > 245 U/L, C-reactive protein > 100 mg/L and lymphocyte count < 800 cells/µL.
- •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 76
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Unconfirmed SARS-CoV-2 infection
- •Pregnant or breastfeeding women
- •Oral or inhaled corticosteroid therapy within 15 days before
- •Oral or inhaled corticosteroid therapy for chronic medical condition
- •Immunosuppressive therapy
- •Cytotoxic chemotherapy within 30 days before
- •Neutrophil count < 1000 cells/mm3 for hematologic malignancy or solid tumor
- •Dementia or psychosis
- •Human immunodeficiency virus infection
- •Patients with liver disease defined as ALT or AST = 5 times the upper limit of normal
- •Patients with kidney disease defined as glomerular filtration rate = 30 ml/min, hemodialysis or peritoneal dialysis
- •Uncontrolled bacterial infection
研究者
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