A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 to Prevent Clinical Deterioration in Patients With Moderate or Severe COVID-19 Infection
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- To evaluate respiratory failure (defined as the need for mechanical ventilation, ECMO, non-invasive ventilation, or high-flow oxygen devices) rate.
研究概览
简要总结
A Phase II Randomized, double-blind, Placebo-controlled Study to Evaluate the safety and efficacy of exosomes overexpressing CD24 to prevent clinical deterioration .The study population will include patients with moderate or severe COVID-19 infection and laboratory markers predictive of the cytokine storm from the Corona department of each site, who have provided an informed consent.
155 patients will be randomized in a 2:1 ratio to receive either 1010 exosome particles (103 patients) or placebo (52 patients).The exosomes will be diluted in 4ml normal saline for inhalation, administered once daily (QD) for 5 days.
Placebo (saline) will be prepared for inhalation and administered in the same manner as the exosomes.
详细描述
The exosomes will be diluted in 4ml normal saline for inhalation, administered once daily (QD) for 5 days.
Placebo (saline) will be prepared for inhalation and administered in the same manner as the exosomes.
Study treatments will be given as add-on to standard of care. Following the 5 days of treatment, patients will remain in follow-up for 23 additional days. Patients who will be discharged before the end of the 5-day treatment period will continue to receive treatment at home. Treatment administration and the study assessments will be carried out by the research personnel at the home of the patient, implementing the required protective measures.
On Day 28, when the isolation period is completed, these patients will arrive at the study site for the follow-up visit.
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
- Double (Participant, Investigator)
盲法说明
155 patients will be randomized in a 2:1 ratio to receive either 1010 exosome particles -103 patients, or placebo- 52 patients.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A COVID-19 diagnosis confirmed with a SARS-coV-2 viral infection positive polymerase chain reaction (PCR) test
- •Age 18-80 years
- •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 >50% within 24-48 hours or a severe deterioration compared to imaging at admission b. Evidence of an exacerbated inflammatory process i. LDH score> 450 U/L ii. CRP >50 mg/L iii. Ferritin >1650 ng/ml iv. Lymphocytes >800 cells/mm3 v. D-dimers >1 mcg/ml
- •Willing and able to sign an informed consent
排除标准
- •Age<18 years or >80 years
- •Any concomitant illness that, based on the judgment of the Investigator is terminal
- •Ventilated patient
- •Pregnancy (positive urine pregnancy test [women of childbearing potential only]) or breastfeeding
- •Patients with Immunodeficiency (eg, CLL, HIV, rituximab therapy)
- •Unwilling or unable to provide informed consent
- •Participation in any other Interventional study in the last 30 days
研究组 & 干预措施
1010 Exosome
103 patients will receive either 1010 exosome particles.
干预措施: Exosomes overexpressing CD24 (Drug)
Placebo
52 patients will receive placebo- saline.
干预措施: Exosomes overexpressing CD24 (Drug)
结局指标
主要结局
To evaluate respiratory failure (defined as the need for mechanical ventilation, ECMO, non-invasive ventilation, or high-flow oxygen devices) rate.
时间窗: One year
To evaluate the death rate.
时间窗: One year
To evaluate the safety of EXO-CD24 in the treatment of patients with moderate or severe COVID-19 disease
时间窗: One year
To assess the efficacy of EXO-CD24 in the clinical improvement of COVID-19 disease
时间窗: One year
To evaluate time to improvement and recovery (COVID-19 clinical severity score of 3 or lower).
时间窗: One year
To evaluate time from hospitalization to hospital discharge.
时间窗: One year
To assess the COVID-19-related symptoms using patient-reported outcome measure (PRO) score.
时间窗: One year
次要结局
- To evaluate the effect of EXO-CD24 on the change in blood oxygen saturation (SpO2).(One year)
- To evaluate the effect of EXO-CD24 on the respiratory rate.(One year)
- To evaluate the effect of EXO-CD24 on the level of inflammatory markers (eg, CRP, ferritin, fibrinogen, di-dimers, IL-6, LDH, lymphocytes count.(One year)
- To evaluate the effect of EXO-CD24 on the proportion of patients requiring ventilation.(One year)
研究者
Eli Sprecher, MD
Dr. Guy Choshen
Tel-Aviv Sourasky Medical Center