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NCT06006611 Clinical Trial

Risk Factors for Severe Disease in Hospitalized Patients With COVID-19 and the Effect of Azvudine Treatment: a Retrospective Cohort Study

COVID-19 Clinical Trial

Official title:
Risk Factors for Severe Disease in Hospitalized Patients With COVID-19 and the Effect

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06006611
Other study ID # ZDWY.BAS.001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 5, 2023
Est. completion date October 30, 2023

Study information
Verified date August 2023
Source Fifth Affiliated Hospital, Sun Yat-Sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to explore the factors that can affect the development of severe cases in hospitalized patients with COVID-19, including basic diseases, laboratory parameters, and clinical manifestations; In addition,to explore whether Azvudine can reduce the mortality of hospitalized patients with COVID-19.

Description:

4201 COVID-19 patients discharged from our hospital were enrolled. Binary logistic regression analysis and ROC curve were used to investigate the role of comorbidities, laboratory parameters and clinical manifestation on progression of COVID-19 patients. We used propensity-score models conditional on baseline characteristics and Univariate Cox regression model to examine whether Azvudine can reduce the mortality of COVID-19 patients.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 4201
Est. completion date October 30, 2023
Est. primary completion date October 25, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: The COVID-19 positive patients Exclusion Criteria: 1. patients treated with both azvudine and monotamivir; 2. patients receiving other antiviral drugs such as nematavir/ritonavir; 3. age < 18 years old

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Azvudine
Received antiviral treatment with azvudine

Locations
Country Name City State
China The Fifth Affiliated Hospital of Sun Yat-sen University Zhuhai Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause mortality of COVID-19 patients All-cause mortality of COVID-19 patients Time from onset to death
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