EUCTR2020-001437-12-ES进行中（未招募）1 期
Random, controlled, open, one-site clinical trial in adult patients with COVID-19 severe pneumonia treated with immunomodulatory drugs
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)0 个研究点目标入组 290 人开始时间: 2020年4月13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
- 290
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. Age 18-80 years
- •2. Severe COVID-19 pneumonia definied as:
- •-Nasnopharyngeal smear SARS-CoV-2 PCR positive
- •-Pulmonary infiltrates by simple X-ray (or other technique) compatible with pneumonia
- •-One or more of the following criteria:
- •oRoom air oxygen saturation <= 94% measured by pulse oximeter
- •oPa:FiO2 (partial pressure O2/fraction of inspired O2) <=300
- •oSa:FiO2 (O2 saturation measured by pulse oximeter/ fraction of inspired O2) <=350
- •3. Informed Consent according to protocol instructions.
- •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 145
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 145
排除标准
- •1. GOT/GPT > 5 the institutional ULN
- •2. Neutrophils < 500 cell/mmc.
- •3. Petelet < 50.000 cell/mmc.
- •4. Documented sepsis o pneumonia different from COVID-19.
- •5. According to clinician criteria, comorbilities with poor prognosis
- •6. Compliate Diverticulitis or bowel perforation
- •7. Current skin infection (p.e piodermitis)
- •8. According to the clinician criteria, any contraindication for using inmunomodulator tretament.
研究者
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