A Phase IIb, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 to Prevent Clinical Deterioration in Patients With Mild-Moderate ARDS
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v.5 during the 28 days of the study.
研究概览
简要总结
This is phase IIb, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 of one dose 10^10 exosome particles, to Prevent Clinical Deterioration in Patients with Mild-Moderate ARDS
详细描述
The study population will include patients with mild-moderate ARDS and laboratory markers predictive of the cytokine storm, who have provided an informed consent.
90 patients will be initially screened, randomized and stratified by center in a 2:1 ratio to receive either 1010 exosome particles (60 patients) or placebo (30 patients).
Study drug will be delivered using standard jet nebulizer that produce aerosol particles size of 0.4-4.4 µm.
The exosomes will be diluted in 1.5 ml normal saline for inhalation, administered twice a day (bid) for 5 days
Study treatments will be given as an add-on to the standard of care. Following the 5 days of treatment, patients will remain in follow-up for 23 additional days. In case of hospital discharge before the full follow-up planned, the patient will be required to return to the site for completion of all study assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The administrated dose will be unknown to the patients
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Direct and indirect lung injury etiology
- •Age ≥18 years
- •Patients with Early Acute Lung Injury (EALI) > 2 ,or patient on HFNC/NIPPV [(1 point for an oxygen requirement > 2 to 6 liters/min or 2 points for > 6 liters/min; 1 point each for a respiratory rate ≥ 30 breaths/min and baseline immune suppression) (immune system compromised by exogenous drug etc.)] (For saturation goal >90%) [1], or ARDS diagnosis (mild/moderate)
- •Willing and able to sign an informed consent, or has a legal guardian who is able to sign
排除标准
- •Any concomitant illness that, based on the judgment of the investigator might affect the interpretation or the results of the study (immunodeficiency, primary immune deficiency due to virus, hematological malignancy etc.)
- •Patients with SaO2/FiO2<150
- •Patients with mechanical ventilation (ECMO).
- •Pregnancy [positive urine pregnancy test (women of childbearing potential only)] or breastfeeding
- •Participation in any other interventional study in the last 30 days or within 5 half-lives of receiving an investigational agent.
研究组 & 干预措施
Group 1: investigational drug EXO-CD24 at a dose of 10^10
60 patients who will receive a 5-day treatment with the investigational drug EXO-CD24 at a dose of 10^10
干预措施: EXO-CD24 (Drug)
Group 2: treatment in a clean sterile saline solution (placebo)
30 patients who will receive a 5-day treatment in a clean sterile saline solution (placebo)
干预措施: Placebo (Other)
结局指标
主要结局
Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v.5 during the 28 days of the study.
时间窗: 28 days
Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 28
时间窗: 28 days
Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 7
时间窗: 7 days
次要结局
未报告次要终点