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

NCT05813600 | Completed

• 1 other identifier: Xiangao Jiang
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Omicron Variant of COVID-19

Keywords

Nirmatrelvir/Ritonavir; COVID-19

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

lianhua qingwen granule

NO INTERVENTION

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

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

Interventions

Nirmatrelvir/Ritonavir DRUG

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.

lianhua qingwen granule+Nirmatrelvir/Ritonavir

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangao Jiang: lead

Study Sites (1)

Xiangao Jiang

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

nirmatrelvir and ritonavir drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 14, 2023
• Study Start: August 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

CN (1)