A Controlled Study to Evaluate the Safety and Efficacy of Allogeneic MesenCure for the Treatment of Pulmonary Manifestations in Patients With COVID19
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Safety of Mesencure
研究概览
简要总结
An open label clinical study to evaluate the safety and the efficacy of MesenCure, an allogeneic cell therapy product, for the treatment of the pulmonary manifestations in COVID19 patients
详细描述
Primary endpoint: The IV administration of MesenCure is safe under the following conditions: in subjects hospitalized with COVID19 moderate to severe disease, defined upon clinical situation and radiologic findings.
Secondary endpoint: The IV administration of MesenCure is efficacious under the following conditions:
Clinical parameters: Health questionnaire, respiratory rate, heart rate, blood pressure, RA O2 saturation, hospitalization duration.
______________________________________________________ Laboratory findings: leukocyte and lymphocyte count, CRP, D-Dimer, renal and liver function, optional: cytokine levels.
______________________________________________________ Radiologic findings: pulmonary infiltrates, pleural effusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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-
- •Female subjects are eligible only if of non-child bearing potential.
- •Documented COVID19
- •O2 Saturation of ≤93%
- •Stable hemodynamic condition (blood pressure of systolic <180mm Hg and diastolic <110mm Hg)
- •Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography.
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 significant heart diseases, 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-40 (HypoThermosol®).
- •Known history of hypersensitivity to Human Serum Albumin.
研究组 & 干预措施
MesenCure treatment
Clinical interventions:
Health questionnaire, respiratory rate, heart rate, blood pressure, RA O2 saturation, x-ray.
Blood tests: leukocyte and lymphocyte count, CRP, D-Dimer, renal and liver function, optional: cytokine levels.
干预措施: MesenCure (Biological)
结局指标
主要结局
Safety of Mesencure
时间窗: 30 days
No treatment-related adverse reactions
次要结局
- Reduction of CRP(14 days)
- Elevation of lymphocytes level(14 days)
- Improvement of health questionnaire(21 days)
- improvement in pulmonary infiltrates/ pulmonary congestion(30 days)
- Reduced hospitalization duration(30 days)
- Improvement in RA-O2 saturation(14 days)