Extended Remdesivir Infusion Combined With Nirmatrelvir/Ritonavir for Persistent SARS-CoV-2 Infection in Immunocompromised Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The proportion of SARS-CoV-2 CT > 30 on Day 14
研究概览
简要总结
To evaluate the safety and efficacy of extended remdesivir infusion, targeting on immunocompromised individuals who had positive SARS-CoV-2 PCR despite an oral antiviral agent prescription.
详细描述
Prolonged viral shedding is commonly observed in immunocompromised patients infected by SARS-CoV-2. Until now, there is no successful clinical trial or guideline to guide optimal treatment for this clinical condition. Here, we aimed to establish a clinical trial with combination of prolonged remdesivir infusion with nirmatrelvir/ritonavir among COVID-19 patients recently receiving b-cell depletion therapy, to evaluate to clinical outcomes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Receive B-cell depletion therapy or bendamustine within 6months
- •Laboratory confirmed SARS-CoV-2 infection
- •Symptoms onset within 72 hours
- •NIAID ordinal score 0-5 upon enrollment
排除标准
- •Prior use of any anti-SARS-CoV-2 agents within 2 weeks. Remdesivir or NMV/r initiated within 24 hours is acceptable
- •Life expectancy < 1 month
- •Previous adverse effect related to remdesivir or NMV/r
- •Concurrent use medicine with drug-drug interaction with NMV/r
- •Patients receiving intubation and mechanical ventilation
- •eGFR < 30
- •Child pugh score Class C
- •Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
研究组 & 干预措施
combination therapy
combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir
干预措施: combination therapy (Drug)
combination therapy
combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir
干预措施: SOC (Drug)
SOC
standard of care
干预措施: SOC (Drug)
结局指标
主要结局
The proportion of SARS-CoV-2 CT > 30 on Day 14
时间窗: From enrollment to the end of treatment on Day 14.
The proportion of SARS-CoV-2 CT \> 30 on Day 14 of each group.
次要结局
- The proportion of mortality or respiratory failure requiring intubation and mechanical ventilation.(From enrollment to the end of treatment on Day 28.)
- The proportion of patients developing anti-viral treatment emerging adverse events.(From enrollment to the end of treatment on Day 28.)
- The proportion of secondary bacterial or fungal infection of each group.(From enrollment to the end of treatment on Day 28.)
- The proportion of viral rebound within 28 days after antiviral agent initiation.(From enrollment to the end of treatment on Day 28.)
研究者
National Taiwan University Clinical Trial Center
Clinical professor,
National Taiwan University Hospital