Back to resultsEfficacy and Safety of Nirmatrelvir/Ritonavir for Treating Omicron Variant of COVID-19
Primary Purpose
Omicron Variant of COVID-19
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nirmatrelvir/Ritonavir
Sponsored by
About this trial
This is an interventional treatment trial for Omicron Variant of COVID-19 focused on measuring Nirmatrelvir/Ritonavir, COVID-19
Eligibility Criteria
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.
Sites / Locations
- Xiangao Jiang
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
lianhua qingwen granule
lianhua qingwen granule+Nirmatrelvir/Ritonavir
Arm 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 ℃.
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.
Outcomes
Primary Outcome Measures
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
Virus turn negative
Compare the first negative conversion(or CT value ≥35) time of coronavirus nucleic acid between two groups
Hospital stays
Compare the difference in hospitalization time between the two groups strictly according to discharge criteria
Adverse drug reaction
Compare the adverse drug reactions during hospitalization between two groups
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05813600
Brief Title
Efficacy and Safety of Nirmatrelvir/Ritonavir for Treating Omicron Variant of COVID-19
Official Title
To Evaluate the Efficacy and Safety of Nirmatrelvir/Ritonavir in the Treatment of the Omicron Variant of COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 2022 (Actual)
Primary Completion Date
December 2022 (Actual)
Study Completion Date
December 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiangao Jiang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Omicron Variant of COVID-19
Keywords
Nirmatrelvir/Ritonavir, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lianhua qingwen granule
Arm Type
No Intervention
Arm 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 ℃.
Arm Title
lianhua qingwen granule+Nirmatrelvir/Ritonavir
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Nirmatrelvir/Ritonavir
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nasal swab COVID-19 nucleic acid tests
Description
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
Title
Virus turn negative
Description
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
Title
Hospital stays
Description
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
Title
Adverse drug reaction
Description
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
Title
COVID-19 nucleic acid re-positive
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Xiangao Jiang
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Nirmatrelvir/Ritonavir for Treating Omicron Variant of COVID-19
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