Efficacy and Safety of Nirmatrelvir/Ritonavir for Treating Omicron Variant of COVID-19
- Conditions
- Omicron Variant of COVID-19
- Interventions
- Registration Number
- NCT05813600
- Lead Sponsor
- Xiangao Jiang
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lianhua qingwen granule+Nirmatrelvir/Ritonavir 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.
- Primary Outcome Measures
Name Time Method Virus turn negative 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Xiangao Jiang
🇨🇳Wenzhou, Zhejiang, China