A Phase IIa, Adaptive, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study in Hospitalized Patients Infected With Severe and Critical SARS-CoV-2 to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001
试验速览
- 阶段
- 2 期
- 发起方
- MedRegen LLC
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This study consists of two parts.
Part A (Phase I):
A Phase I Double-blind Randomized Placebo-controlled Study in Healthy Subjects to Assess the Safety, Pharmacokinetics, Pharmacodynamics of MRG-001
Part B (Phase 2):
A Phase IIa, Adaptive, Double-Blind, Randomized, Placebo-controlled, Multi-center Study in Hospitalized Patients Infected with Severe and Critical SARS-CoV-2 to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001
详细描述
MRG-001 is a fixed-dose combination (FDC) drug, administered as a single subcutaneous (SC) injection. Preclinical studies have demonstrated a synergistic effect of these 2 APIs in mobilizing and recruiting stem cells/immunoregulatory cells and promoting tissue regeneration in a wide variety of studies.
MRG-001 is likely to target multiple aspects of the COVID-19. MRG-001 exhibits immunoregulatory and regenerative properties in preclinical studies with a wide variety of diseases. Repairing damaged tissues in the lung and other organs, restoring the anti-virus immune system and modulating the inflammation are obvious therapeutic targets for COVID-19.
Part A has been completed in May 01, 2021.
Part B has been initiated in January 2022.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MRG-001
Multiple SC dose of 0.0066 mL/kg MRG-001 (n=20) will be administered every other day for the duration of 13 days totaling 7 injections.
干预措施: MRG-001 (Drug)
Placebo
Single SC dose of 0.0066 mL/kg Sterile Injectable Saline (n=20) will be administered every other day for the duration of 13 days totaling 7 injections.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 60 days
To evaluate the safety (SAE's) of MRG-001 in Severe and Critical SARS-CoV-2 patients.
次要结局
- Change in Plerixafor concentration (ng/ml) from baseline in blood(15 days)
- Change in percentages from baseline in circulating white blood cell subpopulations(15 days)
- Change in Tacrolimus concentration (ng/ml) from baseline in blood(15 days)
- Change from baseline in ALT, AST, INR, Albumin, Bilirubin, LDH, BUN, eGFR(15 days)
- Change in percentages from baseline in circulating stem cells and immune cells(15 days)
- Time to clinical improvement from randomization by at least 2 points on the 8-point ordinal scale of WHO clinical improvement scale assessed up to 14 and 60 days (1=Asymptomatic, no limitations of activities; 8=death).(60 days)
- All-cause mortality assessed at 14, 28 and 60 days following randomization.(60 days)