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

Xiangao Jiang58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Omicron Variant of COVID-19

Interventions

Nirmatrelvir/RitonavirDRUG

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

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xiangao Jiang

Wenzhou, Zhejiang, China

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: From date of randomization until the date of first documented progression, assessed up to 5 months

Data from ClinicalTrials.gov

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