An Observational, Ambispective Cohort Study of Azvudine in the Treatment of Patients With COVID-19 Pneumonia

Qianfoshan Hospital

Status: Enrolling

Conditions: COVID-19 Respiratory Infection

Treatments: Drug: Azvudine

Study type: Observational

Funder types: Other

Identifiers

NCT05621993

2022-11-16-QFS

Details and patient eligibility

About

This is a multicenter, ambispective observational cohort study. The patients with corona virus disease 2019 (COVID-19) will be included in the study. The patients will be divided into 4 groups according to the treatment mode (Azvudine treatment group within 48 hours after the first positive for nucleic acid, Azvudine treatment group after 48 hours after the first positive for nucleic acid, short course of Azvudine treatment without nucleic acid turning negative, and the control group) . This study aims to analyze the efficacy and safety of Azvudine in the treatment of patients with COVID-19.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with confirmed diagnosis of COVID-19 pneumonia
• Patients with the ability to take medication orally

Exclusion criteria

• Severe vomiting and difficulty in taking oral medication or ingestion of drugs after oral administration
• Suspected or confirmed active systemic infection other than COVID-19 pneumonia
• Pregnant or lactating women
• Patients with mental disorders
• Patients with severe liver damage
• Patients who are treated with small molecule drugs such as Nirmatrelvir Tablets/Ritonavir Tablets(co-packaged)
• Patients who are treated with RNA-dependent RNA polymerase (RDRP) inhibitors (Junshipharma VV116, Ascletis Pharma Inc. Asc10, Kexing biopharm Shen26, and Molnupiravir).

Trial design

500 participants in 4 patient groups

Combination therapy group

Description:

Patients who are treated with the combination therapy of Azvudine and Chinese herbal medicine will be included in this group. The combination therapy is Azvudine treatment (5 mg once a day) within 48 hours of first positive nucleic acid testing for COVID-19, combined with Chinese herbal medicine treatment.

Treatment:

Drug: Azvudine

Sequential therapy group

Description:

Patients who are treated with the sequential therapy of Azvudine and Chinese herbal medicine will be included in this group. The sequential therapy is Azvudine treatment (5 mg once a day) after 48 hours of first positive nucleic acid testing for COVID-19, combined with Chinese herbal medicine treatment.

Treatment:

Drug: Azvudine

Non-standard therapy group

Description:

Patients are treated with Azvudine combined with Chinese herbal medicine treatment. But Azvudine treatment is discontinued before the nucleic acid turns negative.

Treatment:

Drug: Azvudine

The control group

Description:

Patients are treated with Chinese herbal medicine without Azvudine.