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

• Sponsor: Xiangao Jiang (Other)
• Overall Status: Completed
• CT.gov ID: NCT05813600
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site Per Month: 14.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Omicron Variant of COVID-19	Drug: Nirmatrelvir/Ritonavir	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: To Evaluate the Efficacy and Safety of Nirmatrelvir/Ritonavir in the Treatment of the Omicron Variant of COVID-19
• Actual Study Start Date: Aug 1, 2022
• Actual Primary Completion Date: Dec 1, 2022
• Actual Study Completion Date: Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Nasal swab COVID-19 nucleic acid tests [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

2. Virus turn negative [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

3. Hospital stays [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

4. Adverse drug reaction [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

5. COVID-19 nucleic acid re-positive [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xiangao Jiang	Wenzhou	Zhejiang	China	325000

Sponsors and Collaborators

• Xiangao Jiang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiangao Jiang, Director, Wenzhou Central Hospital
• ClinicalTrials.gov Identifier: NCT05813600
• Other Study ID Numbers: Xiangao Jiang
• First Posted: Apr 14, 2023
• Last Update Posted: Apr 14, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiangao Jiang, Director, Wenzhou Central Hospital: Nirmatrelvir/Ritonavir; COVID-19
• Additional relevant MeSH terms: COVID-19; Ritonavir

Study Results

No Results Posted as of Apr 14, 2023