NCT05682560已完成2 期
A Randomized Controlled Phase IIa, Two-arm Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Treatment-emergent adverse events (TEAEs)
研究概览
简要总结
REGENECYTE (HPC, Cord Blood, hUCB) for treatment in patients with post-COVID.
详细描述
This is a two-arm, single-center, single-blind, randomized, placebo-controlled phase IIa study. A total of 30 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
- Single (Participant)
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 syndrome
- •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
- •Judged by the investigator to be not suitable for study participation
- •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
Treatment-emergent adverse events (TEAEs)
时间窗: Baseline to Week 26
Incidence of treatment-emergent adverse events (TEAEs)
次要结局
- Change of fatigue score as measured by CFQ-11(Baseline, Week 6, 12, 18 and 26)
研究者
研究点 (1)
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