A Retrospective Cohort Study to Evaluate the Efficacy and Safety of Traditional Chinese Medicine as an Adjuvant Treatment for Patients With Severe COVID-19
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Length of hospital stay (days)
研究概览
简要总结
In December 2019, a new type of pneumonia, COVID-2019 outbroke in Wuhan ,China, and currently the infected has been reported in more than at least 75 countries.
Patients with severe COVID-19 have rapid disease progression and high mortality rate. This may attribute to the excessive immune response caused by cytokine storm. Strategies based on anti-virus drugs and treatments against symptoms have now been employed. However, these managements can't effectively treat the lethal lung injury and uncontrolled immune responses, especially in the elderly with severe COVID-19. Traditional Chinese Medicine (TCM), which treats the disease from anther perspective, has achieved satisfactory results. National Health Commission of China released a series of policies to enhance the administration of TCM prescriptions.
This study is aimed to evaluate the efficacy and safety of Traditional Chinese Medicine as an adjuvant treatment for severe COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were diagnosed as severe COVID-19 according to the Coronavirus disease (COVID-19) Treatment Guidance (Six edition)
- •Patients received a combined treatment of TCM and conventional therapy, or only conventional therapy.
排除标准
- •Age >85 years
- •After cardiopulmonary resuscitation
- •Patients combined with other organ failure or conditions need ICU monitoring and treatment, such as severe liver disease, severe renal dysfunction, upper gastrointestinal hemorrhage, disseminated intravascular coagulation.
- •Respiratory failure and need mechanical ventilation
研究组 & 干预措施
Traditional Chinese Medicine
TCM prescription and conventional treatments
干预措施: Traditional Chinese Medicine Prescription (Drug)
结局指标
主要结局
Length of hospital stay (days)
时间窗: First treatment date up to 3 months
次要结局
- Time to Clinical Improvement (TTCI)(First treatment date up to 3 months)
- CT imaging changes(First treatment date up to 3 months)
- Duration (days) of supplemental oxygenation(First treatment date up to 3 months)
- Mortality rate(First treatment date up to 3 months)
- The pneumonia severity index scores(First treatment date up to 3 months)
- Time to COVID-19 nucleic acid testing negativity in throat swab(First treatment date up to 3 months)
- Blood immune cell count(Baseline, 7 and/ or 14 days)
- Serum inflammatory markers(Baseline, 7 and/ or 14 days)
- Erythrocyte sedimentation rate(Baseline, 7 and/ or 14 days)
- Platelet and D-dimer changes(Baseline, 7 and/ or 14 days)
- Creatinine changes(Baseline, 7 and/ or 14 days)
- Muscle enzymes changes(Baseline, 7 and/ or 14 days)
- Usage of antibiotics(First treatment date up to 3 months)
- Usage of glucocorticoids(First treatment date up to 3 months)
- Frequency of adverse events(First treatment date up to 3 months)
研究者
Li Hao
professor
Xiyuan Hospital of China Academy of Chinese Medical Sciences