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

• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06006611
• Collaborator: (none)
• Enrollment: 4,201
• Location: 1
• Anticipated Duration (Days): 25
• Patients Per Site Per Month: 5114.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	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 Design

• Study Type: Observational
• Anticipated Enrollment: 4201 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Risk Factors for Severe Disease in Hospitalized Patients With COVID-19 and the Effect
• Actual Study Start Date: Aug 5, 2023
• Anticipated Primary Completion Date: Aug 25, 2023
• Anticipated Study Completion Date: Aug 30, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. All-cause mortality of COVID-19 patients [Time from onset to death]

   All-cause mortality of COVID-19 patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Fifth Affiliated Hospital of Sun Yat-sen University	Zhuhai	Guangdong	China	519000

Sponsors and Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fifth Affiliated Hospital, Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT06006611
• Other Study ID Numbers: ZDWY.BAS.001
• First Posted: Aug 23, 2023
• Last Update Posted: Aug 23, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Fifth Affiliated Hospital, Sun Yat-Sen University: COVID-19; Azvudine; severity
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Aug 23, 2023