Clinical trial

Real-World Effectiveness and Safety of Oral Azvudine in Hospitalized Patients With COVID-19: A Multicenter, Retrospective, Cohort Study

Name

2023-KY-0865-001

Description

To establish a real-world clinical cohort and database of Azvudine in the treatment of SARS-CoV-2 infection, and to provide stable and reliable evidence for the clinical efficacy and safety evaluation of azvudine in the treatment of SARS-CoV-2 infection.

Trial arms

Trial start

2023-12-05

Estimated PCD

2024-01-15

Trial end

2024-03-10

Status

Completed

Treatment

Azvudine

Antiviral drug

Arms:

Azvudine

Paxlovid

Antiviral drug

Arms:

Paxlovid

Other names:

Nirmatrelvir/Ritonavir

Size

32864

Primary endpoint

All-cause death

Up to 30 days (form the date of confirmed COVID-19)

Eligibility criteria

Inclusion Criteria: 1. Age above 18 years old (including the cut-off value), regardless of gender; 2. Patients diagnosed with 2019-ncov infection according to the diagnostic criteria of the latest edition of the Diagnosis and Treatment Plan for 2019-ncov Pneumonia issued by the Health Commission of China; 3. Informed consent has been signed. Exclusion Criteria: 1. Known or suspected allergic to the components of Azivudine tablets; 2. Patients with severe liver, kidney, heart and other organ damage; 3. Pregnant or lactating women who planned to give birth during or within 6 months after the trial; 4. Had participated in other clinical trials or were using investigational drugs within 12 weeks before medication;

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 32864, 'type': 'ACTUAL'}}

Updated at

2024-04-05

1 organization

2 products

2 indications

Organization

The First Affiliated Hospital of Zhengzhou University

Product

Indication

Indication

Product