NCT07184385尚未招募3 期
A Multicenter, Double-blind, Randomized, Placebo-controlled, Two-arm Phase III Study to Assess the Efficacy of Human Umbilical Cord Blood (REGENECYTE) Infusion in Reducing Fatigue in Post-COVID Condition
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- The change of efficacy
研究概览
简要总结
REGENECYTE (HPC, Cord Blood) for treatment in patients with post-COVID.
详细描述
This is a two-arm, multi-center, double-blind, randomized, placebo-controlled phase III study. A total of 60 subjects with post-COVID will be enrolled.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥ 18
- •With post-COVID condition
- •Has had a recent (within 7 days) negative SARS-CoV-2 test (an approved PCR or antigen test)
- •Able to provide signed informed consent (by the subject or his/her legally authorized representative)
- •Is willing and able to participate in all aspects of the study, including completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing a written informed consent
排除标准
- •Neurological disorders prior to COVID-19 diagnosis
- •With pre-existing terminal illness
- •With known immune disease
- •Is pregnant or breastfeeding
- •Is currently participating in another investigational study or has been taking any other investigational product within the last 4 weeks before screening
- •Has received any vaccination within 3 weeks prior to the first IP infusion or planning to receive vaccination during the treatment period
- •Judged by the investigator to be not suitable for study participation, including but not limited to pre-existing chronic diseases
- •Under the conditions that may increase risk of complications based on the medical judgment of the investigator and the parameters
研究组 & 干预措施
REGENECYTE
Experimental
HPC, Cord Blood
干预措施: REGENECYTE (Biological)
Placebo
Placebo Comparator
Normal Saline
干预措施: Placebo (Biological)
结局指标
主要结局
The change of efficacy
时间窗: Week
Change of efficacy evaluation
次要结局
- Treatment-emergent adverse events (TEAEs)(Week)
研究者
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