Omicron Variant of COVID-19NCT05813600
Efficacy and Safety of Nirmatrelvir/Ritonavir for Treating Omicron Variant of COVID-19
A study testing Nirmatrelvir/Ritonavir in people with Omicron Variant of COVID-19, run by Xiangao Jiang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Omicron Variant of COVID-19
- What is being tested?
- Nirmatrelvir/Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- Aug 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Omicron Variant of COVID-19
- Being tested
- Nirmatrelvir/Ritonavir
- Keywords
- Nirmatrelvir/Ritonavir, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nirmatrelvir/RitonavirDrug
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 group | Role | What they receive |
|---|---|---|
| lianhua qingwen granule | No intervention | 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 ℃. |
| lianhua qingwen granule+Nirmatrelvir/Ritonavir | Experimental | 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. Receives: Drug: Nirmatrelvir/Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From date of randomization until the date of first documented progression, assessed up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study startAug 2022
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Omicron Variant of COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangao Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiangao Jiang, Wenzhou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813600
- Sponsor's protocol ID
- Xiangao Jiang
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of Nirmatrelvir/Ritonavir in the Treatment of the Omicron Variant of COVID-19
- ClinicalTrials.gov ID
- NCT05813600
- Acronym / sponsor ID
- Xiangao Jiang
- Conditions
- Omicron Variant of COVID-19
- Keywords
- Nirmatrelvir/Ritonavir, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Xiangao JiangUniversity, hospital or other
- Study start
- Aug 2022 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lianhua qingwen granule | No intervention | –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 ℃. |
| lianhua qingwen granule+Nirmatrelvir/Ritonavir | Experimental | Drug: Nirmatrelvir/RitonavirPatients 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nirmatrelvir/RitonavirPatients 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. | Drug | lianhua qingwen granule+Nirmatrelvir/Ritonavir |
Primary outcome
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nirmatrelvir/Ritonavir in people with Omicron Variant of COVID-19, run by Xiangao Jiang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal swab COVID-19 nucleic acid tests (time frame: On days 4, 7, 9 and 11 of treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.