An interventional study of Nirmatrelvir/Ritonavir in Omicron Variant of COVID-19, sponsored by Xiangao Jiang. Completed at 1 site in China. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-04-14.
Sponsored by Xiangao Jiang · Not applicable, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 58 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Xiangao Jiang as lead sponsor.
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Exclusion Criteria:
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.
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.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From date of randomization until the date of first documented progression, assessed up to 5 months
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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