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

Xiangao Jiang

Status: Completed

Conditions: Omicron Variant of COVID-19

Treatments: Drug: Nirmatrelvir/Ritonavir

Study type: Interventional

Funder types: Other

Identifiers

NCT05813600

Xiangao Jiang

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

lianhua qingwen granule

No Intervention group

Description:

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 ℃.

lianhua qingwen granule+Nirmatrelvir/Ritonavir

Experimental group

Description:

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.

Treatment:

Drug: Nirmatrelvir/Ritonavir