Efficacy and Safety of Nirmatrelvir/Ritonavir for Treating Omicron Variant of COVID-19
NCT ID: NCT05813600
Last Updated: 2023-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2022-08-31
2022-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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lianhua qingwen granule
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 ℃.
No interventions assigned to this group
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.
Nirmatrelvir/Ritonavir
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.
Interventions
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Nirmatrelvir/Ritonavir
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.
Eligibility Criteria
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Inclusion Criteria
* Age ≥12 years and weight ≥ 40Kg；
* Subjects of fertility must agree to use highly effective contraceptive methods.
Exclusion Criteria
* 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.
12 Years
ALL
No
Sponsors
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Xiangao Jiang
OTHER
Responsible Party
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Xiangao Jiang
Director
Locations
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Xiangao Jiang
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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Xiangao Jiang
Identifier Type: -
Identifier Source: org_study_id
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