The Real-world Clinical Study of Azvudine Tablets in the Treatment of COVID-19

NCT06349655 | Completed DMC

• 1 other identifier: 2023-KY-0865-001
• Study Type: observational
• Target: 32,864
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Azvudine

Outcome Measures

Primary Outcomes (1)

• All-cause death

  All-cause death was ascertained by electronic medical records.

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

Secondary Outcomes (1)

• Composite disease progression

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

Study Arms (3)

Azvudine

COVID-19 patients with Azvudine treatment

Drug: Azvudine

Paxlovid

COVID-19 patients with Paxlovid treatment

Drug: Paxlovid

Control

COVID-19 Patients who have not been treated with Azvudine or Paxlovid

Interventions

Azvudine DRUG

Antiviral drug

Azvudine

Paxlovid DRUG

Antiviral drug

Also known as: Nirmatrelvir/Ritonavir

Paxlovid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People who have COVID-19 and have an indication for Azvudine or Paxlovid.

You may qualify if:

• Age above 18 years old (including the cut-off value), regardless of gender;
• 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;
• Informed consent has been signed.

You may not qualify if:

• Known or suspected allergic to the components of Azivudine tablets;
• Patients with severe liver, kidney, heart and other organ damage;
• Pregnant or lactating women who planned to give birth during or within 6 months after the trial;
• Had participated in other clinical trials or were using investigational drugs within 12 weeks before medication;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead
• Henan Provincial Chest Hospital: collaborator
• The Affiliated Infectious Disease Hospital of Zhengzhou University: collaborator
• The Fifth People's Hospital of Anyang: collaborator
• Shangqiu Municipal Hospital: collaborator
• Nanyang Central Hospital: collaborator
• Luoyang Central Hospital: collaborator
• Guangshan County People's Hospital: collaborator
• Fengqiu County People's Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Related Publications (2)

• Wang F, Jia B, Li G, Jin X, Yang M, Li G, Zhang S, Qian G, Luo H, Cheng M, Wang L, Zhang D, Li S, Liang H, Ren Z. Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, China. BMJ Open. 2025 Jun 27;15(6):e090230. doi: 10.1136/bmjopen-2024-090230.

  PMID: 40578868 DERIVED

• Su G, Gao F, Yang M, Wang L, Liang L, Li S, Li G, Han N, Li G, Qian G, Zhang S, Luo H, Zhang D, Liang H, Ren Z. Effectiveness of azvudine versus nirmatrelvir/ritonavir for hospitalized patients with SARS-CoV-2 infection and pre-existing liver diseases. Virol J. 2025 May 19;22(1):147. doi: 10.1186/s12985-025-02771-1.

  PMID: 40389963 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

azvudine; nirmatrelvir and ritonavir drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zujiang Yu, Dr.

  The First Affiliated Hospital of Zhengzhou University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 5, 2024
• Study Start: December 5, 2023
• Primary Completion: January 15, 2024
• Study Completion: March 10, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

CN (1)