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

The First Affiliated Hospital of Zhengzhou University32,864 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

32,864

Conditions

COVID-19 Azvudine

Interventions

AzvudineDRUG

Antiviral drug

PaxlovidDRUG

Antiviral drug

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Locations (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Outcomes

Primary Outcomes

All-cause death

All-cause death was ascertained by electronic medical records.

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

Secondary Outcomes

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.

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

Data from ClinicalTrials.gov

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