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

NCT ID: NCT06349655

Last Updated: 2024-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32864 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-05

Study Completion Date

2024-03-10

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19 Azvudine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Azvudine

COVID-19 patients with Azvudine treatment

Azvudine

Intervention Type DRUG

Antiviral drug

Paxlovid

COVID-19 patients with Paxlovid treatment

Paxlovid

Intervention Type DRUG

Antiviral drug

Control

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

No interventions assigned to this group

Interventions

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Azvudine

Antiviral drug

Intervention Type DRUG

Paxlovid

Antiviral drug

Intervention Type DRUG

Other Intervention Names

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Nirmatrelvir/Ritonavir

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan Provincial Chest Hospital

OTHER

Sponsor Role collaborator

The Affiliated Infectious Disease Hospital of Zhengzhou University

UNKNOWN

Sponsor Role collaborator

The Fifth People's Hospital of Anyang

UNKNOWN

Sponsor Role collaborator

Shangqiu Municipal Hospital

UNKNOWN

Sponsor Role collaborator

Nanyang Central Hospital

OTHER

Sponsor Role collaborator

Luoyang Central Hospital

OTHER

Sponsor Role collaborator

Guangshan County People's Hospital

UNKNOWN

Sponsor Role collaborator

Fengqiu County People's Hospital

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role lead

Responsible Party

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Zhigang Ren

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zujiang Yu, Dr.

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Zhengzhou University

Locations

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The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40578868 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40389963 (View on PubMed)

Other Identifiers

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2023-KY-0865-001

Identifier Type: -

Identifier Source: org_study_id

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