Clinical trial

Efficacy and Safety of Azvudine in the Treatment of Patients With Corona Virus Disease (COVID-19) Pneumonia in China: an Multi-center Observational, Ambispective Cohort, Real-world Study

Name
2022-11-16-QFS
Description
This is a multicenter, ambispective observational cohort study. The patients with corona virus disease 2019 (COVID-19) will be included in the study. The patients will be divided into 4 groups according to the treatment mode (Azvudine treatment group within 48 hours after the first positive for nucleic acid, Azvudine treatment group after 48 hours after the first positive for nucleic acid, short course of Azvudine treatment without nucleic acid turning negative, and the control group) . This study aims to analyze the efficacy and safety of Azvudine in the treatment of patients with COVID-19.
Trial arms
Trial start
2022-11-22
Estimated PCD
2023-11-16
Trial end
2023-12-31
Status
Recruiting
Treatment
Azvudine
Azvudine is a small molecular antiviral drug. On August 9, 2022, Azvudine was included in the Diagnostic and therapeutic protocol for COVID-9 in China.
Arms:
Combination therapy group, Non-standard therapy group, Sequential therapy group
Size
500
Primary endpoint
Time from positive nucleic acid to negative
every 3 days
Eligibility criteria
Inclusion Criteria: * Patients with confirmed diagnosis of COVID-19 pneumonia * Patients with the ability to take medication orally Exclusion Criteria: * Severe vomiting and difficulty in taking oral medication or ingestion of drugs after oral administration * Suspected or confirmed active systemic infection other than COVID-19 pneumonia * Pregnant or lactating women * Patients with mental disorders * Patients with severe liver damage * Patients who are treated with small molecule drugs such as Nirmatrelvir Tablets/Ritonavir Tablets(co-packaged) * Patients who are treated with RNA-dependent RNA polymerase (RDRP) inhibitors (Junshipharma VV116, Ascletis Pharma Inc. Asc10, Kexing biopharm Shen26, and Molnupiravir).
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}
Updated at
2023-10-03

1 organization

1 product

1 indication

Product
Azvudine
Indication
COVID-19