Double-blind, Randomized, Controlled, Clinical Trial to Assess the Efficacy of Allogenic Mesenchymal Stromal Cells in Patients With Acute Respiratory Distress Syndrome Due to COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in the PaO2/FiO2* Ratio From Baseline to Day 7 of Treatment Administration
研究概览
简要总结
A double-blind, randomized, controlled, clinical trial to evaluate the efficacy and safety of MSC (mesenchymal stromal cells) intravenous administration in patients with COVID-induced ARDS compared to a control arm.
详细描述
A double-blind, randomized, controlled, clinical trial to evaluate the efficacy and safety of MSC (mesenchymal stromal cells) intravenous administration in patients with COVID-induced ARDS compared to a control arm.
All trial participants will receive SOC*.
Randomization will be 1:1 between:
-
Treatment arm: allogenic MSC.
-
Control arm: Placebo (solution with the same composition as the experimental treatment, without the MSC).
-
SOC can include any medicines that are being used in clinical practice (e.g. lopinavir/ritonavir; hydroxy/chloroquine, tocilizumab, etc.).
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)
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
- •Informed consent prior to performing study procedures (witnessed oral consent with written consent by representatives will be accepted to avoid paper handling). Written consent by patient or representatives will be obtained whenever possible.
- •Adult patients ≥18 years of age at the time of enrolment.
- •Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in oropharyngeal swabs or any other relevant specimen obtained during the course of the disease. Alternative tests (e.g., rapid antigenic tests) are also acceptable as laboratory confirmation if their specificity has been accepted by the Sponsor.
- •Moderate to severe ARDS (PaO2/FiO2 ratio equal or less than 200 mmHg) for less than 96 hours at the time of randomization.
- •Patients requiring invasive ventilation are eligible within 72 hours from intubation.
- •Eligible for ICU admission, according to the clinical team.
排除标准
- •Imminent and unavoidable progression to death within 24 hours, irrespective of the provision of treatments (in the opinion of the clinical team).
- •"Do Not Attempt Resuscitation" order in place.
- •Any end-stage organ disease or condition, which in the investigator's opinion, makes the patient an unsuitable candidate for treatment.
- •History of a moderate/severe lung disorder requiring home-based oxygen therapy.
- •Patient requiring ECMO, hemodialysis or hemofiltration at the time of treatment administration.
- •Current diagnosis of pulmonary embolism.
- •Active neoplasm, except carcinoma in situ or basalioma.
- •Known allergy to the products involved in the allogenic MSC production process.
- •Current pregnancy or lactation (women with childbearing potential should have a negative pregnancy test result at the time of study enrollment).
- •Current participation in a clinical trial with an experimental treatment for COVID-19 (the use of any off-label medicine according to local treatment protocols is not an exclusion criteria).
- •Any circumstances that in the investigator's opinion compromises the patient's ability to participate in the clinical trial.
研究组 & 干预措施
Mesenchymal Stromal cells
Approximately 1x10E6 MSC/kg
干预措施: Mesenchymal stromal cells (Biological)
Control group
Solution identical to experimental treatment, without the MSC
干预措施: Placebo (Other)
结局指标
主要结局
Change in the PaO2/FiO2* Ratio From Baseline to Day 7 of Treatment Administration
时间窗: 7 days
Change in the PaO2/FiO2 ratio from baseline to day 7 of treatment administration, or to the last available PaO2/FiO2 ratio if death occurs before day 7. If an arterial blood gas result cannot be obtained, the SaO2/FiO2 ratio could be substituted for the PaO2/FiO2 ratio
次要结局
- New Onset Fibrosis at 12 Months(12 months)
- Proportion of Patients That Were Discharged at Day 28(28 days)
- Duration of Hospitalization(28 days)
- Proportion of Patients That Required ICU Admission(12 months)
- Duration of ICU Admission(12 months)
- Mortality at Day 28(28 days)
- Mortality at 12 Months(12 months)
- Improvement of ≥1 Category at World Health Organization 7 Point Scale(From baseline until day 7, and on day 28 after treatment)
- Time to Improvement of ≥1 Category at WHO 7-point Scale(28 days)
- Patients That Had Oxygen Therapy Withdrawn by Day 28(28 days)
- Time to Discontinuation of Oxygen Therapy (WHO ≤3)(28 days)
研究者
Cristina Avendaño Solá
Head of Clinical Pharmacology Deptarment
Puerta de Hierro University Hospital