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
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Collection of serious adverse events
研究概览
简要总结
This is a phase II randomized, single-blind dose study to evaluate the safety and efficacy of exosomes overexpressing CD24 of two doses, Dose 1 - 10^9 exosome particles (per dose) versus Dose 2 - 10^10 exosome particles (per dose), to prevent clinical deterioration in patients with Moderate or Severe COVID-19 infection.
详细描述
The study population will include patients with moderate or severe COVID-19 and laboratory markers predictive of the cytokine storm, who have provided an informed consent.
90 patients will be randomized in a 1:1 ratio to receive either 109 exosome particles (45 patients) or 1010 exosome particles (45 patients).
The exosomes will be diluted in normal saline for inhalation via mouthpiece nebulization, administered once daily (QD) 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 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 infection positive polymerase chain reaction (PCR) within 30 days of screening.
- •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 >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
- •Willing and able to sign an informed consent.
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 (i.e., immunodeficiency).
- •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.
- •Previous complete or partial vaccination for SARS-CoV-
- •Pregnancy [positive urine pregnancy test (women of childbearing potential only)] or breastfeeding.
- •Participation in any other Interventional study in the last 30 days
- •Active cancer.
研究组 & 干预措施
10^9 dose of exosomes overexpressing CD24
The patients will receive the dose of 10^9 exosomes overexpressing CD24
干预措施: CovenD24 (Drug)
10^10 dose of exosomes overexpressing CD24
The patients will receive the dose of 10^10 exosomes overexpressing CD24
干预措施: CovenD24 (Drug)
结局指标
主要结局
Collection of serious adverse events
时间窗: Through study completion, an average of 4 months
* Incidence of treatment (dose)-related serious adverse events. * Incidence of all adverse events related or unrelated to the study treatment.
Proportion of patients related with Respiratory rate and SpO2 saturation
时间窗: Through study completion, an average of 4 months
* Proportion of patients with respiratory rate \< 23/min for at least 24 hours, on Day 7. * Proportion of patients with SpO2 saturation \>94%, on room air for at least 24 hours, on Day 7. * Proportion of patients with a decrease by 50% in either CRP/LDH/Fibrinogen/Ferritin/D-dimers from baseline to Day 7.
次要结局
- No need for mechanical ventilation(Through study completion, an average of 4 months)
- No of patients that will need Intensive Care Unit(Through study completion, an average of 4 months)
- Improvement of COVID19 status from severe to moderate(Through study completion, an average of 4 months)
- Death rate(Through study completion, an average of 4 months)
- Patients status regarding haemodynamic instability(Through study completion, an average of 4 months)
- Time to death or respiratory failure(Through study completion, an average of 4 months)
- Hospital discharge time(Through study completion, an average of 4 months)
- No of patients with respiratory rate < 23/min(Through study completion, an average of 4 months)
- No of patients with changes in the neutrophil-to-lymphocyte ratio(Through study completion, an average of 4 months)
- No of patients with change in respiratory change(Through study completion, an average of 4 months)
- Changes in absolute lymphocyte count(Through study completion, an average of 4 months)
- No of patients with changes in disease severity(Through study completion, an average of 4 months)
- Changes in common COVID-19 related symptoms(Through study completion, an average of 4 months)
- Changes in supplemental oxygen over time(Through study completion, an average of 4 months)
- Time to recovery(Through study completion, an average of 4 months)
- Oxygen saturation(Through study completion, an average of 4 months)
- No of patients with change in oxygen saturation(Through study completion, an average of 4 months)
- No of patients with SpO2 >94%(Through study completion, an average of 4 months)
- Time of disease improvement(Through study completion, an average of 4 months)
- Changes in COVID-19 clinical severity(Through study completion, an average of 4 months)
- No of patients with change in lymphocyte count(Through study completion, an average of 4 months)
- Changes in the neutrophil-to-lymphocyte ratio(Through study completion, an average of 4 months)
- Duration of oxygen administration(Through study completion, an average of 4 months)