EUCTR2020-001505-22-ES进行中（未招募）1 期
Double-blind, randomized, parallel, placebo-controlled pilot clinical trial, nested in a prospective cohort observational study, for the evaluation of the efficacy and safetyof two doses of WJ-MSC in patients with acute respiratory distress syndrome secondary to infection by COVID-19 - COVIDMES
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
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.Participation in the prospective observational epidemiological study CIBERESUCICOVID (PCR for SARS-CoV-2 positive, ICU admission)
- •2.Moderate acute respiratory distress (Berlin criteria definition with 100 mmHg < PaO2/FiO2 = 200 mmHg)
- •3.Male or female, aged 18 to 70 years old
- •4.Signed informed consent by the patient or by a legal representative
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Expected survival less than 3 days
- •2.Treatment with immunosuppressive drugs (tocilizumab, sarilumab) with corticosteroids being allowed
- •3.Neoplastic disease either active or without complete remission
- •4.Immunosuppressed patients (except treatment with corticosteroids for respiratory distress)
- •5.Pregnant or lactating women
- •6.Participation in another clinical trial with an experimental drug in the last 30 days
- •7.Other pathologies that, in medical judgment, contraindicate participation in the study
研究者
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