EUCTR2020-002434-33-ES进行中（未招募）1 期
Phase 3 randomized study to evaluate the safety and efficacy of aprotinin (Trasylol®) administered by inhalation nebulization in patients diagnosed with SARS-CoV-2 (COVID-19) with moderate severity compared to standard therapy. - EFFICACY OF APROTININE IN COVID-19.
Hospital General Universitario Ciudad Real0 个研究点目标入组 105 人开始时间: 2022年2月24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
- 105
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
- •Patients 18 years and older, either sex. Healthy volunteers are not
- •Patients with moderate SARS-CoV-2 pneumonia confirmed with a
- •diagnosis of polymerase chain reaction (PCR) before randomization. The
- •patient should be hospitalized and require ongoing medical care for
- •SARS-CoV-2. With peripheral capillary O2 saturation levels (SpO2 ) >
- •90% breathing ambient air. With radiographic evidence of pulmonary
- •infiltrates
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Those patients who do not present the signed documents, or whose
- •informed consent is not obtained at a date prior to the completion of the
- •study or any specific intervention in it.
- •Patients who have had a previous exposure to aprotinin in the last 6
- •months or with a known suspected allergy to aprotinin or high levels of
- •antiprotinin IgG.
- •Patients with a history of bleeding diathesis, deep vein thrombosis or
- •pulmonary embolism or known clotting factor deficiency Based on the
- •researcher's opinion on any medically significant active disease the
- •patient may have.
- •Patients who refuse to receive allogeneic blood products
- •Patients with low red blood cell volume with blood transfusion needs
- •(preoperative hematocrit of < 24% or hemoglobin of < 8 g / dl).
- •Patients with a history of allergic asthma or lung atopy reactions or COPD.
- •Patients with sepsis.
- •Participation in any other clinical trial of an experimental treatment for
- •SARS-CoV-2 or any other clinical trial in the last 30 days.
- •Concurrent treatment with other agents with antiviral action actual or
- •potential direct SARS-CoV-2 exposure < 24 hours prior to dosing of the
- •study drug.
- •Require mechanical ventilation at screening.
- •Subjects with poor renal function (serum creatinine <2.5 mg/dL or 221
- •Pregnant or breastfeeding women or women of childbearing age in
- •The possibility of pregnancy cannot be excluded by a pregnancy test
- •negative and that they are not using a reliable method of contraception.
- •Administration of other antifibrinolytic drugs (e.g., acid aminocaproic or
- •tranexamic acid), or those patients undergoing chronic anticoagulant
- •with acenocoumarol or warfarin that cannot be stopped temporarily the
研究者
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