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

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 Overview

• Status: Completed
• Conditions: COVID-19; Azvudine
• Intervention / Treatment: Drug: Azvudine; Drug: Paxlovid

• Study Type: Observational
• Enrollment (Actual): 32864

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450052
      • the First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People who have COVID-19 and have an indication for Azvudine or Paxlovid.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Azvudine; COVID-19 patients with Azvudine treatment	Drug: Azvudine; Antiviral drug
Paxlovid; COVID-19 patients with Paxlovid treatment	Drug: Paxlovid; Antiviral drug; Other Names: Nirmatrelvir/Ritonavir
Control; COVID-19 Patients who have not been treated with Azvudine or Paxlovid

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhengzhou University
• Collaborators: Luoyang Central Hospital; Nanyang Central Hospital; The Fifth People's Hospital of Anyang; Henan Provincial Chest Hospital; The Affiliated Infectious Disease Hospital of Zhengzhou University; Shangqiu Municipal Hospital; Guangshan County People's Hospital; Fengqiu County People's Hospital
• Investigators: Study Director: Zujiang Yu, Dr., the First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2023
• Primary Completion (Actual): January 15, 2024
• Study Completion (Actual): March 10, 2024

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Nirmatrelvir; Nirmatrelvir and ritonavir drug combination
• Other Study ID Numbers: 2023-KY-0865-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No