Omicron Variant of COVID-19
Conditions
Keywords
Nirmatrelvir/Ritonavir, COVID-19
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.
Interventions
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.
Sponsors
Xiangao Jiang
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
China
Outcome results
None listed