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

April 12, 2023 updated by: Xiangao Jiang

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Xiangao Jiang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: lianhua qingwen granule
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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal swab COVID-19 nucleic acid tests
Time Frame: On days 4, 7, 9 and 11 of treatment
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
Time Frame: From date of randomization until the date of first documented progression, assessed up to 5 months
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
Time Frame: From date of randomization until the date of first documented progression, assessed up to 5 months
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
Time Frame: From date of randomization until the date of first documented progression, assessed up to 5 months
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
Time Frame: From date of randomization until the date of first documented progression, assessed up to 5 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangao Jiang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

April 7, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xiangao Jiang

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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