EUCTR2020-005887-70-CZ进行中（未招募）1 期
Effect of dexamethasone in patients with ARDS and COVID-19 – prospective, multi-centre, open-label, parallel-group, randomized controlled trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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. Adult (= 18 years of age) at time of enrolment;
- •2. Present COVID-19 (infection confirmed by RT-PCR or antigen testing);
- •3. Intubation/mechanical ventilation or ongoing high-flow nasal cannula (HFNC) oxygen therapy;
- •4. Moderate or severe ARDS according to Berlin criteria:
- •Moderate – PaO2/FiO2 100–200 mmHg;
- •Severe – PaO2/FiO2 < 100 mmHg;
- •5. Admission to ICU in the last 24 hours.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1. Known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol);
- •2. Fulfilled criteria for ARDS for = 14 days at enrolment;
- •3. Pregnancy or breastfeeding;
- •4. Unwillingness to comply with contraception measurements from the enrolment to at least 1 week after the last dose of dexamethasone (sexual abstinence is considered as the adequate contraception method);
- •5. End-of-life decision or patient is expected to die within next 24 hours;
- •6. Decision not to intubate or ceilings of treatment in place;
- •7. Immunosuppression and/or immunosuppressive drugs in medical history:
- •a) Systemic immunosuppressive drugs or chemotherapy in the past 30 days;
- •b) Systemic corticosteroids use before hospitalization;
- •c) Corticosteroids administration (dexamethasone equal or less than 8 mg per day or other corticosteroids in equivalent dose) during the present hospital stay for COVID-19 for more than last 5 days before enrolment;
- •d) Systemic corticosteroids during present hospital stay for other conditions than COVID-19 (e.g. septic shock);
- •e) Dexamethasone more than 8 mg per day or other corticosteroids in equivalent dose during the present hospital stay for COVID-19 for more than one single dose;
- •8. Present haematological or generalized solid malignancy;
- •9. Any of contraindications of corticosteroids, e.g.
- •intractable hyperglycaemia;
- •active gastrointestinal bleeding;
- •adrenal gland disorders;
- •a presence of superinfection diagnosed with locally established clinical and laboratory criteria without adequate antimicrobial treatment;
- •10. Cardiac arrest before ICU admission;
- •11. Participation in another interventional trial in the last 30 days.
研究者
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