EUCTR2020-006130-12-IT进行中（未招募）1 期
Multicenter randomized, double-blind, placebo-controlled, clinical trial of Acetylsalicylic acid in the prevention of severe COVID-19 pneumonia in hospitalised patients (Asperum) - Clinical trial of Acetylsalicylic acid in the prevention of severe SARS-CoV2 pneumonia in hospitalis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 204
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
- •Hospitalization in a medical area ward dedicated to Covid-19 patients
- •Positivity by RT_PCR of the search for genetic material of SARS-CoV2
- •Covid-19 pneumonia with moderate clinical picture based on clinical parameters
- •O2 saturation> 94% with maximum FiO2 32%
- •Respiratory acts <30 / minute
- •age >18 years
- •Consent to participate in the study
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 154
排除标准
- •Any Antithrombotic treatment including acetylsalicylic acid
- •Active Bacterial infection
- •Active or in maintenance therapy neoplasm
- •Inability to provide consent
- •Any contraindication to the acetylsalicylic acid use
- •Active peptic disease
- •Active Major pathological bleeding
- •Recent (<30 days) major bleeding
- •Recent intracranial bleeding
- •Need to use therapeutic doses of oral anticoagulants or heparins
- •Need to use combination antiplatelet drugs for clinical indication
- •Hypersensitivity to acetylsalicylic acid or to any of the excipients
- •Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)
- •Severe hepatic insufficiency (Child-Pugh class C).
- •Severe heart failure (NYHA class 3-4)
- •Platelet count less than 150000 / mmc
- •Haemostasis alteration (INR> 1.5, APTT> 1.5)
- •Plasma fibrinogen <100 mg / dL
- •Blood pressure >160/100 mmHg
- •Concomitant treatment with serotonin reuptake inhibitors
- •Participation in another pharmacological clinical trial
研究者
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