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

Recruiting

• Conditions: COVID-19 Respiratory Infection
• Interventions: Drug: Azvudine

• Registration Number: NCT05621993
• Lead Sponsor: Qianfoshan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-18
• Study Start: 2022-11-22
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-03
• Primary Completion: 2023-11-16
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sequential therapy group	Azvudine	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.
Combination therapy group	Azvudine	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.
Non-standard therapy group	Azvudine	Patients are treated with Azvudine combined with Chinese herbal medicine treatment. But Azvudine treatment is discontinued before the nucleic acid turns negative.

Primary Outcome Measures

Name	Time	Method
Time from positive nucleic acid to negative	every 3 days	The time from the day when patients are first positive nucleic acid to the day when the Ct value of nucleic acid test is ≥35 or the result of nucleic acid test is negative.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with relapsed positive nucleic acid test within 28 days after negative	up tp 28 days
Proportion of patients with adverse events	up tp 28 days

Trial Locations

Locations (1)

Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China; 🇨🇳 Jinan, Shandong, China