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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06349655
Enrollment
32864
Registered
2024-04-05
Start date
2023-12-05
Completion date
2024-03-10
Last updated
2024-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Azvudine

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.

Interventions

Antiviral drug

Antiviral drug

Sponsors

Henan Provincial Chest Hospital
CollaboratorOTHER
The Affiliated Infectious Disease Hospital of Zhengzhou University
CollaboratorUNKNOWN
The Fifth People's Hospital of Anyang
CollaboratorUNKNOWN
Shangqiu Municipal Hospital
CollaboratorUNKNOWN
Nanyang Central Hospital
CollaboratorOTHER
Luoyang Central Hospital
CollaboratorOTHER
Guangshan County People's Hospital
CollaboratorUNKNOWN
Fengqiu County People's Hospital
CollaboratorUNKNOWN
The First Affiliated Hospital of Zhengzhou University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
All-cause deathUp to 30 days (form the date of confirmed COVID-19)All-cause death was ascertained by electronic medical records.

Secondary

MeasureTime frameDescription
Composite disease progressionUp to 30 days (form the date of confirmed COVID-19)Disease progression is defined as the occurrence of death, progression to severe or critical disease in mild or moderate patients, and the occurrence of death, progression to critical disease in severe patients. Severe disease is defined as respiratory rate ≥ 30 times/minute, or resting oxygen saturation ≤ 93%, or PaO2/FiO2 ≤ 300 mmHg, or lung lesions progressing \>50% at 24-48 hours. Critical disease is defined as the need for mechanical ventilation, or shock, or ICU monitoring.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026