NCT05749445

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

February 16, 2023

Last Update Submit

February 26, 2023

Conditions

Hospitalized Patients

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Nirmatrelvir-Ritonavir

Hospitalized patients receiving at least one dose Nirmatrelvir-Ritonavir

Drug: Nirmatrelvir-Ritonavir

Interventions

Nirmatrelvir-RitonavirDRUG

Nirmatrelvir-Ritonavir

Also known as: PAXLOVID
Nirmatrelvir-Ritonavir

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospitalized patients receiving at least one dose nirmatrelvir-ritonavir

You may qualify if:

  • hospitalized patients receiving at least one dose nirmatrelvir-ritonavir

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changcheng Shi

Hangzhou, Zhejiang, 310006, China

RECRUITING

Related Publications (2)

  • Lamb YN. Nirmatrelvir Plus Ritonavir: First Approval. Drugs. 2022 Apr;82(5):585-591. doi: 10.1007/s40265-022-01692-5.

    PMID: 35305258BACKGROUND

  • 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.

    PMID: 36423149BACKGROUND

Related Links

MeSH Terms

Interventions

nirmatrelvir and ritonavir drug combination

Study Officials

  • Changcheng Shi

    First People's Hospital of Hangzhou

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Changcheng Shi

CONTACT

86-13967157030cpushicc@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2023

First Posted

March 1, 2023

Study Start

December 15, 2022

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)