Efficacy and Safety of Nirmatrelvir/Ritonavir for Treating Omicron Variant of COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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To Evaluate the Efficacy and Safety of Nirmatrelvir/Ritonavir in the Treatment of the Omicron Variant of COVID-19

Conditions
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Omicron Variant of COVID-19

Intervention / Treatment
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* Drug: Nirmatrelvir/Ritonavir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: lianhua qingwen granule<br>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 ℃. | |
| Experimental: lianhua qingwen granule+Nirmatrelvir/Ritonavir<br>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. | Drug: Nirmatrelvir/Ritonavir<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal swab COVID-19 nucleic acid tests | 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 | On days 4, 7, 9 and 11 of treatment | 
| Virus turn negative | Compare the first negative conversion(or CT value ≥35) time of coronavirus nucleic acid between two groups | From date of randomization until the date of first documented progression, assessed up to 5 months | 
| Hospital stays | Compare the difference in hospitalization time between the two groups strictly according to discharge criteria | From date of randomization until the date of first documented progression, assessed up to 5 months | 
| Adverse drug reaction | Compare the adverse drug reactions during hospitalization between two groups | From date of randomization until the date of first documented progression, assessed up to 5 months | 
| COVID-19 nucleic acid re-positive | 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 | From date of randomization until the date of first documented progression, assessed up to 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nirmatrelvir/Ritonavir, COVID-19