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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05749445
Other study ID # AEATN
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 15, 2022
Est. completion date April 2023

Study information

Verified date February 2023
Source First People's Hospital of Hangzhou
Contact Changcheng Shi
Phone 86-13967157030
Email cpushicc@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of the study was to assess the appropriateness of antiviral therapy with nirmatrelvir-ritonavir in hospitalized patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date April 2023
Est. primary completion date April 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - hospitalized patients receiving at least one dose nirmatrelvir-ritonavir Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nirmatrelvir-Ritonavir
Nirmatrelvir-Ritonavir

Locations

Country Name City State
China Changcheng Shi Hangzhou Zhejiang

Sponsors (4)

Lead Sponsor Collaborator
First People's Hospital of Hangzhou First People's Hospital of Lin'an District, First People's Hospital of Yuhang District, Hangzhou Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline
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