EUCTR2021-002184-22-GR进行中（未招募）1 期
A phase II randomized, single-blind dose study to evaluate the safety and efficacy of exosomes overexpressing CD24 in 10^9 dose versus 10^10 dose, for the prevention of clinical deterioration in patients with moderate or severe COVID-19
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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. A COVID-19 diagnosis confirmed with a SARS-CoV-2 infection positive polymerase chain reaction (PCR) test within 30 days from screening.
- •2.Age 18-80 years.
- •3.Severity of disease according to the following criteria (at least one clinical parameter and one laboratory parameter are required):
- •a.Clinical and Imaging-based evaluation
- •i.Respiratory rate > 23/min and < 30/min
- •ii.SpO2 at room air =94% and =90%
- •iii.Bilateral pulmonary infiltrates >25% within 24-48 hours or a severe deterioration compared to imaging at admission.
- •b.Evidence of an exacerbated inflammatory process
- •i.LDH =300 U/L or what is the upper limit for normal per age
- •ii.CRP =25 mg/L
- •iii.Ferritin =500 ng/ml
- •iv.Lymphocytes <800 cells/mm3
- •v.D-dimers =500ng/ml
- •4.Willing and able to sign an informed consent.
- •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 40
排除标准
- •1.Any concomitant illness that, based on the judgment of the Investigator might affect the interpretation or the results of the study (i.e., immunodeficiency).
- •2.Mechanically-ventilated patient or patient who will probably require ICU admission or mechanical ventilation within 24 hours from enrolment, according to the Investigator’s judgment.
- •3.Previous complete or partial vaccination for SARS-CoV-2.
- •4.Pregnancy [positive urine pregnancy test (women of childbearing potential only)] or breastfeeding.
- •5.Participation in any other Interventional study in the last 30 days
- •6. Active Cancer
研究者
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