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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Drug: Azvudine

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 4201

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Zhuhai, Guangdong, China, 519000
      • The Fifth Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The COVID-19 positive patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Azvudine group; Azvudine group included COVID-19 patients treated with azvudine antiviral therapy;	Drug: Azvudine; Received antiviral treatment with azvudine
No antiviral group; No antiviral group included COVID-19 patients treated with no antiviral therapy;
Monotamivir; Monotamivir group included COVID-19 patients treated with monotamivir antiviral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality of COVID-19 patients	All-cause mortality of COVID-19 patients	Time from onset to death

Collaborators and Investigators

• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2023
• Primary Completion (Estimated): October 25, 2023
• Study Completion (Estimated): October 30, 2023

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; severity; Azvudine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ZDWY.BAS.001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Publication of academic papers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes