The Effect of Paxlovid in the Treatment of COVID-19 Patients With Uremia
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 40
- 主要终点
- time of negative conversion of SARS-CoV-2 nucleic acid
研究概览
简要总结
This study is a single-center, open-label, randomized controlled clinical study to evaluate the effect of Paxlovid on the virus-negative time and disease progression in uremic patients infected with SARS-CoV-2 (omicron variants).
This study will enroll maintenance hemodialysis patients infected with SARS-CoV-2 (omicron variants).
After signing the informed consent form, the qualified subjects will be randomly stratified 1:1 to standard-of-care (SOC) or SOC plus Paxlovid for five days.
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
- •Sign informed consent. Age ≥ 18 years old. COVID-19 (nucleic acid test positive) was diagnosed before randomization. At least 1 symptom or sign of COVID-19 at the time of being enrolled into the study(symptoms and signs related to COVID-19 including cough, expectoration, dyspnea, fever, chills, fatigue, muscle soreness, diarrhea, headache, sore throat, stuffy nose, runny nose, etc.).
排除标准
- •History of active liver disease, including chronic or active hepatitis B or C, primary biliary cirrhosis, Child-Pugh B or C, or acute liver failure.
- •HIV infection and the viral load is greater than 400 copies/ml. Suspected or confirmed active systemic infections that may have an impact on the study evaluation except for COVID-
- •Acute heart failure, respiratory failure, severe chronic kidney disease, and cardiovascular disease caused by uremia-related complications.
- •Allergic to any ingredients of Paxlovid.
研究组 & 干预措施
standard-of-care
Standard-of-care of COVID-19 includes oxygen inhalation, antibiotics, traditional medicine, etc.
干预措施: standard-of-care (Drug)
standard-of-care plus Paxlovid
standard-of-care of COVID-19 plus Paxlovid
干预措施: Paxlovid (Drug)
standard-of-care plus Paxlovid
standard-of-care of COVID-19 plus Paxlovid
干预措施: standard-of-care (Drug)
结局指标
主要结局
time of negative conversion of SARS-CoV-2 nucleic acid
时间窗: up to 60 days
Time from first positive to negative of SARS-CoV-2 nucleic acid
Proportion of ICU transfer or disease progression to severe or critical illness
时间窗: up to 60 days
次要结局
未报告次要终点