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

Zhengzhou University

Status: Completed

Conditions: COVID-19; Azvudine

Treatments: Drug: Azvudine; Drug: Paxlovid

Study type: Observational

Funder types: Other

Identifiers

NCT06349655

2023-KY-0865-001

Details and patient eligibility

About

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.

Enrollment: 32,864 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

32,864 participants in 3 patient groups

Azvudine

Description:

COVID-19 patients with Azvudine treatment

Treatment:

Drug: Azvudine

Paxlovid

Description:

COVID-19 patients with Paxlovid treatment

Treatment:

Drug: Paxlovid

Control

Description:

COVID-19 Patients who have not been treated with Azvudine or Paxlovid