NCT05719012撤回2 期
Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19: a Randomized, Double-blind, Parallel-controlled Study
Shanghai East Hospital1 个研究点 分布在 1 个国家开始时间: 2023年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Lung function
研究概览
简要总结
To explore the efficacy and safety of Umbilical cord mesenchymal stem cells in the treatment of long COVID-19
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •The age ranges from 18 to 85 (inclusive), regardless of gender.
- •Patients with Confirmed SARS-CoV-2 infection, according to the consensus of the Chinese diagnostic criteria for COVID-19 (Tentative tenth Edition).
- •Patients with symptoms of long COVID-19 3 months from the onset of COVID-19, lasting for at least 2 months, and the symptoms cannot be explained by other diseases.
- •Be expected to live longer than 1 year.
- •Volunteer to participate in this clinical study and sign the written informed consent.
排除标准
- •Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation.
- •T lymphocyte abnormality, HIV positive.
- •Highly allergic or have a history of severe allergy.
- •Pregnant and lactating women.
- •Patients with severe autoimmune disease history;
- •Patients with uncontrolled chronic diseases or serious complications;
- •Patients with malignant tumors;
- •Patients with pulmonary embolism, acute coronary syndrome, cerebral embolism or at high risk of thromboembolism;
- •Patients with severe organ dysfunction
- •Other situations that the researchers think are not suitable for participating in this study
结局指标
主要结局
Lung function
时间窗: Changes from the baseline index at Day 30, Day 60, Day 90 and Day 180
The lung function assessed using FEV1, FEV1/FVC and DLco
Six min walking distances
时间窗: Changes from baseline index at Day 30, Day 60, Day 90 and Day 180
The maximum distance a person can walk in 6 min and acts as an endurance walking measure.
次要结局
- Changes of the levels of Inflammatory cytokines(Changes from the baseline levels at Day 30, Day 60, Day 90 and Day 180)
- Changes of the scores of Multidimensional Fatigue Inventory(Changes from the baseline scores at Day 30, Day 60, Day 90 and Day 180)
研究者
研究点 (1)
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