To Evaluate the Efficacy and Safety of Nirmatrelvir/Ritonavir in the Treatment of the Omicron Variant of COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Virus turn negative
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of Nirmatrelvir/Ritonavir in the treatment of the Omicron variant of COVID-19. The main question it aims to answer is: Whether the use of the drug can help patients recover from COVID-19.
Patients in both groups were given Lianhua Qingwen Capsule orally, 3 times/day, 6 g/time. oral antipyretic (ibuprofen suspension 10ml) and symptomatic supportive treatment for body temperature >38.5 ℃. The study group was given Nirmatrelvir 300mg/Ritonavir 100mg orally, q12h, for 5 days, and the control group not given any antiviral drugs.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmation of COVID-19 infection within 24h and positive nasopharyngeal swab for COVID-19 nucleic acid RNA；
- •Age ≥12 years and weight ≥ 40Kg；
- •Subjects of fertility must agree to use highly effective contraceptive methods.
排除标准
- •Previous history of COVID-19 treatment；
- •The known history of active liver disease；
- •Patients on renal dialysis or have moderate to severe impaired renal function；
- •The known human immunodeficiency virus (HIV) infection;
- •Suspected or confirmed concurrent active systemic infections other than COVID-19 infection；
- •Allergy or other contraindication to any component of the study intervention;
- •Any drug or substance that is currently or expected to be used that is a high reliance on CYP3A4 enzyme clearance or strong CYP3A4 enzyme inducers；
- •pregnant or breastfeeding women.
研究组 & 干预措施
lianhua qingwen granule+Nirmatrelvir/Ritonavir
Patients were given Lianhua Qingwen Capsule orally, 3 times/day, 6 g/time. oral antipyretic (ibuprofen suspension 10ml) and symptomatic supportive treatment for body temperature >38.5 ℃. And given Nirmatrelvir 300mg/Ritonavir 100mg orally, q12h, for 5 days.
干预措施: Nirmatrelvir/Ritonavir (Drug)
结局指标
主要结局
Virus turn negative
时间窗: From date of randomization until the date of first documented progression, assessed up to 5 months
Compare the first negative conversion(or CT value ≥35) time of coronavirus nucleic acid between two groups
Hospital stays
时间窗: From date of randomization until the date of first documented progression, assessed up to 5 months
Compare the difference in hospitalization time between the two groups strictly according to discharge criteria
Adverse drug reaction
时间窗: From date of randomization until the date of first documented progression, assessed up to 5 months
Compare the adverse drug reactions during hospitalization between two groups
COVID-19 nucleic acid re-positive
时间窗: From date of randomization until the date of first documented progression, assessed up to 5 months
After discharge, patients in both groups continued to be isolated at the isolation point for 7 days and underwent COVID-19 nucleic acid tests daily to compare the COVID-19 nucleic acid re-positive
Nasal swab COVID-19 nucleic acid tests
时间窗: On days 4, 7, 9 and 11 of treatment
Patients in both groups underwent nasal swab COVID-19 nucleic acid tests on days 4, 7, 9 and 11 of treatment, and CT values were recorded (CT values of 40 for negative results). Compare the difference in the change of CT values of COVID-19 nucleic acid between two groups of patients
次要结局
未报告次要终点
研究者
Xiangao Jiang
Director
Wenzhou Central Hospital