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

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

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.

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.