EUCTR2020-001857-31-BG进行中（未招募）1 期
A Randomized, Controlled, Multicenter, Parallel-Group Phase IIa Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of severe COVID-19
Pluristem Ltd.0 个研究点目标入组 40 人开始时间: 2020年11月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet all of the inclusion criteria listed below to be eligible for the study:
- •1. Willing and able to provide written informed consent, or with a legal representative (as defined by local regulation) who can provide informed consent.
- •2. Male or non-pregnant female 18 to 85 years of age at time of randomization.
- •3. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen within up to 28 days prior to randomization.
- •4. Meets definition of ARDS according to Berlin criteria with oxygenation of PaO2/FIO2 = 200mm Hg (graded as Moderate or Severe).
- •5. By the time of expected treatment initiation on invasive mechanical ventilation for less than 72 hours.
- •6. Women of childbearing potential must have a negative serum pregnancy test at primary screening and must be willing to use at least one highly effective birth control method
- •throughout the study.
- •Any female subject who is surgically sterile, or with bilateral tubal occlusion, or whose partner is vasectomized, or who reliably applies sexual abstinence or who is postmenopausal (one year
- •without menses) will be considered not of childbearing potential.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Subjects with any one of the exclusion criteria listed below will not be eligible for the study (based on medical record at current admission):
- •1. Mild ARDS as defined by Berlin criteria (200 mm Hg < PaO2/FIO2 = 300mmHg)
- •2. Body weight under 55 kg (121 lbs)
- •3. Stage 4 and above chronic kidney disease (clearly defined in patient’s medical history, eGFR <30 mL/min/1.73m2 [based on MDRD equation]) or patients that require renal replacement
- •therapy for any reason at time of primary screening.
- •4. Serum creatinine level of over 3 mg/dL at last test before randomization.
- •5. Total Bilirubin =3 mg/dL at last test before randomization.
- •6. Continuous administration of vasoactive agents required due to shock at time of randomization (either one): dopamine >15 (mcg/kg/min), vasopressin >0.04 (units/min), phenylephrine >1
- •(mcg/kg/min), epinephrine =0.3 (mcg/kg/min), or norepinephrine =0.3 (mcg/kg/min).
- •7. Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin.
- •8. Stroke or acute myocardial infarction within 3 months before current hospital.
- •9. Congestive heart failure (New York Heart Association [NYHA] class III-IV) at primary screening (stated in medical history) or investigator discretion as to presence of moderate to severe baseline congestive heart failure.
- •10. Chronic Obstructive Pulmonary disease GOLD stage above III (Stated in medical history or investigator discretion of severe COPD.
- •11. Other chronic pulmonary disease under chronic oxygen treatment.
- •12. Known medical history of Acquired immunodeficiency syndrome (AIDS) or HIV under chronic treatment.
- •13. Known medical history of Active acute or chronic HBV or HCV .
- •14. Known medical history of active tuberculosis or active tuberculosis including under treatment at time of primary screening .
- •15. Pre-existing significant coagulopathies that put the patient at an increased risk of major bleeding according to the Investigator’s judgment.
- •16. History of thromboembolism or known chronic hypercoagulopathic syndrome\state.
- •17. Subjects under acute or chronic anticoagulant therapy (warfarin with international normalized ratio (INR) >2 or Direct Oral Anticoagulants, or full dose subcutaneous or intravenous
- •treatment for atrial fibrillation and\or prosthetic heart valves, and or suspicion or proven thromboembolic events), unless this therapy is required and can be safely modified , according
- •to local clinical routines (e.g. PTT monitoring, timing of low molecular heparin injections), around the time of PLX-PAD injections based on the study Investigator’s/ treating physician’s discretion and patient’s risk of bleeding.
- •18. Subject is currently enrolled in another controlled clinical trial(s) with investigational drug, unless in long-term follow-up phase (in which there is no IP administration).
- •19. Exposure to allogeneic cell-based therapy in the past or exposure to autologous cell therapy in the last 12 months before screening.
- •20. History of solid organ transplantation.
- •21. Active malignancy or history of malignancy within 3 years prior to screening except for successfully resected skin basal cell carcinoma or skin squamous cell carcinoma.
- •22. Treatment with extracorporeal membrane oxygenation (ECMO) support (at time of randomization).
- •23. In the opinion of the Investigator, the subject is unsuitable for participating in the study.
研究者
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