Risk Factors for Severe Disease in Hospitalized Patients... | NCT06006611

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

NCT06006611

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Status

Unknown status

Last Update Posted

Sep 21, 2023Actual

Enrollment

4,201Estimated

Phase

Not provided

Conditions

COVID-19

Interventions

Azvudine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 5, 2023Actual

Primary Completion Date

Oct 25, 2023Estimated

Completion Date

Oct 30, 2023Estimated

First Submitted Date

Aug 21, 2023

First Submission Date that Met QC Criteria

Aug 21, 2023

First Posted Date

Aug 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2023

Last Update Posted Date

Sep 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,201Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Azvudine group	Azvudine group included COVID-19 patients treated with azvudine antiviral therapy;	Drug: 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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azvudine	Drug	Received antiviral treatment with azvudine	Azvudine group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The COVID-19 positive patients

Exclusion Criteria:

patients treated with both azvudine and monotamivir;
patients receiving other antiviral drugs such as nematavir/ritonavir;
age < 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The COVID-19 positive patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Fifth Affiliated Hospital of Sun Yat-sen University		Zhuhai	Guangdong	519000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Publication of academic papers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C540945	azvudine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided