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

Completed

• Conditions: COVID-19; Azvudine
• Interventions: Drug: Azvudine; Drug: Paxlovid

• Registration Number: NCT06349655
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-05
• Primary Completion: 2024-01-15
• Study Completion: 2024-03-10
• Status Verified: 2024-04
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Study First Posted: 2024-04-05
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32864

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Azvudine	Azvudine	COVID-19 patients with Azvudine treatment
Paxlovid	Paxlovid	COVID-19 patients with Paxlovid treatment

Primary Outcome Measures

Name	Time	Method
All-cause death	Up to 30 days (form the date of confirmed COVID-19)	All-cause death was ascertained by electronic medical records.

Secondary Outcome Measures

Name	Time	Method
Composite disease progression	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China