Hospitalized PatientsNCT05749445
Appropriate Evaluation of Antiviral Therapy With Nirmatrelvir-ritonavir in Hospitalized Patients
An observational study of Hospitalized Patients, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
The primary objective of the study was to assess the appropriateness of antiviral therapy with nirmatrelvir-ritonavir in hospitalized patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hospitalized Patients
- What is being tested?
- Nirmatrelvir-Ritonavir
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2022to Apr 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: hospitalized patients receiving at least one dose nirmatrelvir-ritonavir
Who may be able to join
- hospitalized patients receiving at least one dose nirmatrelvir-ritonavir
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changcheng Shi
Hangzhou, Zhejiang, 310006
Changcheng Shi, 86-13967157030, cpushicc@163.com
About this study
Official title: Appropriate Evaluation of Antiviral Therapy With Nirmatrelvir-ritonavir in Hospitalized Patients: a Multicenter Retrospective Study in China
The primary objective of the study was to assess the appropriateness of antiviral therapy with nirmatrelvir-ritonavir in hospitalized patients.
- Conditions
- Hospitalized Patients
- Being tested
- Nirmatrelvir-Ritonavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nirmatrelvir-RitonavirDrug
Also called PAXLOVID
Nirmatrelvir-Ritonavir
| Study group | Role | What they receive |
|---|---|---|
| Nirmatrelvir-Ritonavir | Hospitalized patients receiving at least one dose Nirmatrelvir-Ritonavir Receives: Drug: Nirmatrelvir-Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of inappropriate use of nirmatrelvir-ritonavir
Four aspects were evaluated to identify the rationality of prescribing NMVr, including indication, administration (dose, timing, and duration), contraindications, and drug-drug interactions.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start15 Dec 2022
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hospitalized PatientsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Cancer Hospital, The First People's Hospital of Yuhang District
- Responsible party
- Sponsor
- Investigators
- Changcheng Shi, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749445
- Sponsor's protocol ID
- AEATN
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lamb YN. Nirmatrelvir Plus Ritonavir: First Approval. Drugs. 2022 Apr;82(5):585-591. doi: 10.1007/s40265-022-01692-5.
PubMed 35305258Akinosoglou K, Schinas G, Gogos C. Oral Antiviral Treatment for COVID-19: A Comprehensive Review on Nirmatrelvir/Ritonavir. Viruses. 2022 Nov 17;14(11):2540. doi: 10.3390/v14112540.
PubMed 36423149
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Evaluation of Antiviral Therapy With Nirmatrelvir-ritonavir in Hospitalized Patients: a Multicenter Retrospective Study in China
- ClinicalTrials.gov ID
- NCT05749445
- Acronym / sponsor ID
- AEATN
- Conditions
- Hospitalized Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Collaborators
- Hangzhou Cancer Hospital, The First People's Hospital of Yuhang District
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 1 Mar 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 primary objective of the study was to assess the appropriateness of antiviral therapy with nirmatrelvir-ritonavir in hospitalized patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nirmatrelvir-Ritonavir | – | Drug: Nirmatrelvir-RitonavirHospitalized patients receiving at least one dose Nirmatrelvir-Ritonavir |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- hospitalized patients receiving at least one dose nirmatrelvir-ritonavir
Key inclusion criteria (1 listed)
- hospitalized patients receiving at least one dose nirmatrelvir-ritonavir
Key exclusion criteria (1 listed)
- None
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-RitonavirAlso: PAXLOVIDNirmatrelvir-Ritonavir | Drug | Nirmatrelvir-Ritonavir |
Primary outcome
The prevalence of inappropriate use of nirmatrelvir-ritonavir
Time frame: baseline
Four aspects were evaluated to identify the rationality of prescribing NMVr, including indication, administration (dose, timing, and duration), contraindications, and drug-drug interactions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 35305258Lamb YN. Nirmatrelvir Plus Ritonavir: First Approval. Drugs. 2022 Apr;82(5):585-591. doi: 10.1007/s40265-022-01692-5.
- Background: PubMed 36423149Akinosoglou K, Schinas G, Gogos C. Oral Antiviral Treatment for COVID-19: A Comprehensive Review on Nirmatrelvir/Ritonavir. Viruses. 2022 Nov 17;14(11):2540. doi: 10.3390/v14112540.
- COVID-19 Drug InteractionsLink provided by the sponsor.
- Fact sheet for healthcare providers: Emergency use authorization for PaxlovidLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Changcheng Shi principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalized Patients, run by First People's Hospital of Hangzhou 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Changcheng Shi (86-13967157030, cpushicc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of inappropriate use of nirmatrelvir-ritonavir (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05749445, which also lists 2 linked publications.
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 1 Mar 2023.