Paxlovid in the treatment of COVID-19
| ISRCTN | ISRCTN12428408 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12428408 |
- Submission date
- 09/03/2023
- Registration date
- 18/03/2023
- Last edited
- 10/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Since the COVID-19 outbreak, the treatment of patients with COVID-19 pneumonia has been an issue of concern. At present, there is no specific drug for COVID-19, only symptomatic treatment, and the treatment of moderate and severe patients is a major difficulty. The emergence of nematavir/ritonavir tablets (PaxlovidTM ) has brought new hope for the treatment of COVID-19 and has shown an effective inhibitory effect on the Omicron variant of COVID-19.
Who can participate?
Patients aged 12 years and over infected with the Omicron variant of COVID-19
What does the study involve?
Patients were retrospectively collected and divided into two groups according to the treatment regimen. Patients in both groups were given Lianhua Qingwen Capsule orally, three times/day, 6 g/time. The study group was given nirmatrelvir 300 mg/ritonavir 100 mg orally, every 12 hours, for 5 days, and the control group was not given any antiviral drugs. The two groups were compared in terms of the change in COVID-19 tests, hospitalization time and adverse drug reactions.
What are the possible benefits and risks of participating?
The study could play an important guiding role in the treatment of the COVID-19 Omicron variant in the future, and reduce the pain and disease burden of patients.
Where is the study run from?
Wenzhou Central Hospital (China)
When is the study starting and how long is it expected to run for?
January 2022 to December 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Chaochao Qiu, 790485628@qq.com
Contact information
Principal Investigator
No. 252, Baili East Road
Lucheng District
Wenzhou City
325000
China
| Phone | +86 (0)86718290 |
|---|---|
| 790485628@qq.com |
Study information
| Study design | Retrospective study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Retrospective study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Paxlovid in the treatment of COVID-19 |
| Study acronym | PIT |
| Study objectives | The efficacy of nirmatrelvir/ritonavir in the treatment of the Omicron variant of COVID-19 was positive and had good tolerance in patients |
| Ethics approval(s) | Approved 14/11/2022, Ethics Committee of Wenzhou Central Hospital (252 Baili Dong Lu, Lucheng District, Wenzhou City, Zhejiang Province, China; +86 (0)577 88070000; weybgs@163.com), ref: L2022-04-082 |
| Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) |
| Intervention | 58 cases infected with the Omicron variant of COVID-19 were retrospectively collected and divided into two groups according to the treatment regimen. Patients in both groups were given Lianhua Qingwen Capsule orally, three times/day, 6 g/time. The study group was given nirmatrelvir 300 mg/ritonavir 100 mg orally, q12h, for 5 days, and the control group was not given any antiviral drugs. The two groups were compared in terms of the change in CT values of COVID-19 nucleic acid, the negative conversion time of COVID-19 RNA, hospitalization time, adverse drug reactions, and COVID-19 nucleic acid re-positive. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | Nirmatrelvir/ritonavir |
| Primary outcome measure | CT values (CT values of 40 for negative results) of nasal swab COVID-19 nucleic acid tests on days 4, 7, 9 and 11 of treatment |
| Secondary outcome measures | 1. First negative conversion time (or CT value ≥40) of COVID-19 nucleic acid tests 2. Hospitalization time, strictly according to discharge criteria 3. Adverse drug reactions recorded during hospitalization 4. COVID-19 nucleic acid re-positive in daily COVID-19 nucleic acid tests in the 7 days of isolation after discharge |
| Overall study start date | 01/01/2022 |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 58 |
| Total final enrolment | 58 |
| Key inclusion criteria | 1. Confirmation of COVID-19 infection within 24 h and positive nasopharyngeal swab for COVID-19 nucleic acid RNA 2. Age ≥12 years and weight ≥40 kg 3. Subjects of fertility must agree to use highly effective contraceptive methods |
| Key exclusion criteria | 1. Previous history of COVID-19 treatment 2. A known history of active liver disease 3. Patients on renal dialysis or have moderate to severe impaired renal function 4. The known human immunodeficiency virus (HIV) infection 5. Suspected or confirmed concurrent active systemic infections other than COVID-19 infection 6. Allergy or other contraindication to any component of the study intervention 7. 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 8. Pregnant or breastfeeding women |
| Date of first enrolment | 15/11/2022 |
| Date of final enrolment | 30/12/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Lucheng District
Wenzhou City
325000
China
Sponsor information
Hospital/treatment centre
No. 252, Baili East Road
Lucheng District
Wenzhou City
325000
China
| Phone | +86 (0)86718290 |
|---|---|
| 790485628@qq.com | |
| Website | https://www.wzhosp.com/ |
"ROR" |
https://ror.org/00w5h0n54 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 20/04/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 13/07/2023 | 10/10/2023 | Yes | No |
Editorial Notes
10/10/2023: Publication reference added.
17/03/2023: Trial's existence confirmed by the Wenzhou No.6 People's Hospital.
