Appropriate Evaluation of Antiviral Therapy With Nirmatrelvir-ritonavir in Hospitalized Patients

February 26, 2023 updated by: First People's Hospital of Hangzhou

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • Changcheng Shi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

hospitalized patients receiving at least one dose nirmatrelvir-ritonavir

Description

Inclusion Criteria:

  • hospitalized patients receiving at least one dose nirmatrelvir-ritonavir

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nirmatrelvir-Ritonavir
Hospitalized patients receiving at least one dose Nirmatrelvir-Ritonavir
Drug: Nirmatrelvir-Ritonavir
Nirmatrelvir-Ritonavir
Other Names:
  • PAXLOVID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First People's Hospital of Hangzhou

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

February 26, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 26, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEATN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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