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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06349655
• Other study ID #: 2023-KY-0865-001
• Status: Completed
• Start date: December 5, 2023
• Est. completion date: March 10, 2024

Study information

• Verified date: April 2024
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32864
• Est. completion date: March 10, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Azvudine
Antiviral drug
• Paxlovid
Antiviral drug

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (9)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University	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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death	All-cause death was ascertained by electronic medical records.	Up to 30 days (form the date of confirmed COVID-19)
Secondary	Composite disease progression	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.	Up to 30 days (form the date of confirmed COVID-19)