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

N/AUnknownNCT05621993

Qianfoshan Hospital500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

COVID-19 Respiratory Infection

Interventions

AzvudineDRUG

Azvudine is a small molecular antiviral drug. On August 9, 2022, Azvudine was included in the Diagnostic and therapeutic protocol for COVID-9 in China.

Eligibility

Medical Language ↔ Plain English

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).

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

RECRUITING

Outcomes

Primary Outcomes

Time from positive nucleic acid to negative

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.

Time frame: every 3 days

Secondary Outcomes

Proportion of patients with relapsed positive nucleic acid test within 28 days after negative

Time frame: up tp 28 days

Proportion of patients with adverse events