NCT05497401尚未招募3 期
A Controlled Study to Evaluate the Efficacy of Allogeneic MesenCure for the Treatment of Patients With ARDS
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- CRP reduction
研究概览
简要总结
The efficacy of the allogeneic cell-therapy product MesenCure in addition to standard of care will be evaluated in comparison to placebo control in 300 moderate to severe Covid patients
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients are able and agree to sign informed consent form before any study-specific procedure.
- •Males or females, age range 18-
- •Documented ARDS
- •RA-O2 Saturation of ≤93% and/or Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography
- •Stable hemodynamic condition (blood pressure of systolic <180mm Hg and diastolic <110mm Hg)
排除标准
- •Pregnant or breast-feeding females.
- •History of drug abuse.
- •Heavy smokers (above 2 packages a day).
- •Subjects incapable of giving consent.
- •Background medical conditions:
- •Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation.
- •History of advanced congestive heart failure or active acute myocardial infarction (AMI), renal failure (estimated GFR of <30 ml/min/1.73 m2 at screening), or hepatic disease (hepatic insufficiency classified as Child-Pugh B or C).
- •Known autoimmune diseases.
- •Received any investigational drug within 30 days prior to screening day (Visit 1) (Remdesivir is not considered investigational, and is not an exclusion criteria).
- •Immunocompromised condition from any reason, at screening.
- •Abnormal clinically significant laboratory test findings, as per the investigator's judgment.
- •Poorly controlled diabetic subjects (HbA1c > 9%).
- •Known active lung malignancy.
- •Concomitant treatment:
- •Currently treated with Immunosuppressive agents other than corticosteroids used for treating COVID
- •Treatment for cancer (i.e. chemotherapy or radiotherapy treatment) within the last 12 months.
- •Hypersensitivity:
- •Known history of hypersensitivity to Dextran-
- •Known history of hypersensitivity to Human Serum Albumin.
研究组 & 干预措施
treatment
Experimental
干预措施: MesenCure (Biological)
control
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
CRP reduction
时间窗: 14 days
Blood CRP is measured in mg/dL
Mortality
时间窗: 1 month
Invasive ventilation
时间窗: 1 month
次要结局
未报告次要终点
研究者
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