Appropriate Evaluation of Antiviral Therapy With Nirmatrelvir-ritonavir in Hospitalized Patients
Sponsor
First People's Hospital of Hangzhou (Other)
Overall Status
Recruiting
CT.gov ID
NCT05749445
Collaborator
Hangzhou Cancer Hospital (Other), First People's Hospital of Lin'an District (Other), First People's Hospital of Yuhang District (Other)
200
1
3.5
56.9
Study Details
Study Description
Brief Summary
The primary objective of the study was to assess the appropriateness of antiviral therapy with nirmatrelvir-ritonavir in hospitalized patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Appropriate Evaluation of Antiviral Therapy With Nirmatrelvir-ritonavir in Hospitalized Patients: a Multicenter Retrospective Study in China
Actual Study Start Date
:
Dec 15, 2022
Anticipated Primary Completion Date
:
Apr 1, 2023
Anticipated Study Completion Date
:
Apr 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Nirmatrelvir-Ritonavir Hospitalized patients receiving at least one dose Nirmatrelvir-Ritonavir |
Drug: Nirmatrelvir-Ritonavir
Nirmatrelvir-Ritonavir
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The prevalence of inappropriate use of nirmatrelvir-ritonavir [baseline]
Four aspects were evaluated to identify the rationality of prescribing NMVr, including indication, administration (dose, timing, and duration), contraindications, and drug-drug interactions.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- hospitalized patients receiving at least one dose nirmatrelvir-ritonavir
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Changcheng Shi | Hangzhou | Zhejiang | China | 310006 |
Sponsors and Collaborators
- First People's Hospital of Hangzhou
- Hangzhou Cancer Hospital
- First People's Hospital of Lin'an District
- First People's Hospital of Yuhang District
Investigators
- Principal Investigator: Changcheng Shi, First People's Hospital of Hangzhou
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- COVID-19 Drug Interactions
- Fact sheet for healthcare providers: Emergency use authorization for Paxlovid
Publications
- Akinosoglou 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.
- Lamb YN. Nirmatrelvir Plus Ritonavir: First Approval. Drugs. 2022 Apr;82(5):585-591. doi: 10.1007/s40265-022-01692-5. Erratum In: Drugs. 2022 Jun;82(9):1025.
Responsible Party:
First People's Hospital of Hangzhou
ClinicalTrials.gov Identifier:
NCT05749445
Other Study ID Numbers:
- AEATN
First Posted:
Mar 1, 2023
Last Update Posted:
Mar 1, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: