EUCTR2020-002186-34-ES进行中（未招募）1 期
Efficacy of the early use of corticotherapy in CoV-2 infection to prevent the progression of acute respiratory distress syndrome (ARDS) in COVID-19
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR).0 个研究点目标入组 100 人开始时间: 2020年7月22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
- 100
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
- •2. Coronavirus-19 infection (SARS-CoV-2) demonstrated by nasopharyngeal smears PCR or any other biological sample
- •3. COVID-19 described as:
- •- Nasopharyngeal smear with SARS-CoV-2 positive PCR
- •- Lung infiltrates by radiography (or other imaging technique) consistent with pneumonia
- •- Puntuation of 3 or 4 in the WHO Ordinal Scale for Clinical Improvement for COVID-19
- •- One of the following criteria:
- •a) Ambient air oxygen saturation> 90 and <94%
- •b) Pa: FiO2 (partial pressure O2 / fraction of inspired O2)> 200 and =300 mmHg
- •c) Sa: FiO2 (O2 saturation measured with
- •pulse oximeter / inspired O2 fraction) =350
- •- All patients will receive standard treatment according to site guidelines (eg hydroxychloroquine), as long as there is no contraindication for it.
- •5. 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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Previous treatment with oral or intravenous corticosteroids for more than 5 days in a row or alternate days (6 previous months)
- •2.Treatment during the previous 12 months with biological drugs such as monoclonal antibodies including anti-TNFa, anti-interleukins, Interferons type I.
- •3.Any other contraindication for the use of individualized corticosteroid pulses according to the clinical criteria of the patient medical team.
- •4.Contraindications to treatment with methylprednisolone (limited to known hypersensitivity to the active substance and its excipients), as well as receiving treatment in a post-vaccination period (with live or live attenuated microorganism vaccines).
- •5.Patients with severe SDRA, defined as SaFi < 150.
- •6.Patients with chronic obstructive pulmonary disease requiring home oxygen.
研究者
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