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Completed

NCT Number: NCT06349655

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

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.

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Key information

Conditions

COVID-19 Azvudine Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Treatment and study plan

Azvudine

Drug

Antiviral drug

Paxlovid

Drug

Antiviral drug

Other names: Nirmatrelvir/Ritonavir

Primary outcomes

  1. All-cause death

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

    All-cause death was ascertained by electronic medical records.

Secondary outcomes

  1. Composite disease progression

    Time frame: Up 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.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2024
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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