Efficiency and Safety of Nicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- changes in absolute lymphocyte counts
研究概览
简要总结
The mechanism of peripheral blood lymphocyte decline in COVID-19 patients is not yet clear. However, one theory demonstrated that in the whole progression of COVID-19, the extensive activation of poly-ADP-ribose polymerase (PARP) may reduce the cellular NAD+ and dampen the adaptive immune system. So investigators presume that replenishing the NAD+ using nicotinamide as the precursor may improve the lymphocyte counts and boost the adaptive immune system. As a result, the study using nicotinamide as a kind of supportive therapy provide further evidence of their efficiency and safety in treating lymphopenia in patients with 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
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients diagnosed as the common or severe cases of COVID-19
- •aged 18-85
- •the absolute lymphocyte counts below the normal value (<1.1-3.2×109/L)
排除标准
- •the patients who are diagnosed as critically ill cases or participating in other clinical trials
- •women who are pregnant or lactating
- •ALT/AST > 5 times upper limit of normal (ULN), neutrophils counts < 0.5×109/L, platelets counts< 50×109/L
- •patients diagnosed with rheumatoid immune-related diseases
- •patients who take long-term oral anti-rejection drugs or immunomodulatory drugs
- •hypersensitive reaction to nicotinamide or any auxiliary materials
- •patients with active tuberculosis or combined with bacterial and fungal infections
- •patients undergoing organ transplant
- •patients with mental disorders.
研究组 & 干预措施
nicotinamide plus usual care
干预措施: nicotinamide (Drug)
结局指标
主要结局
changes in absolute lymphocyte counts
时间窗: before and 48 hours after intervention
the changes in absolute lymphocyte counts (\*10\^9/L) in before and 48 hours after treatment
次要结局
- the death in hospital(before and 48 hours after intervention)
- the composite endpoint of aggravation(before and 48 hours after intervention)
研究者
Qiang Hu
Principal Investigator
Shenyang Northern Hospital