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Active, not recruitingNCT06006611Updated Sep 21, 2023

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

An observational study in COVID-19, sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2023, 2 years 11 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
4,201
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • COVID-19

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Keywords

  • COVID-19
  • Azvudine
  • severity
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 4,201 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 57 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The COVID-19 positive patients

Inclusion criteria

The COVID-19 positive patients

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
4,201 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugAzvudine

    Received antiviral treatment with azvudine

06

What researchers measure

Primary outcomes

  1. All-cause mortality of COVID-19 patients

    All-cause mortality of COVID-19 patients

    Time frame: Time from onset to death

07

Study locations

1 site
  • The Fifth Affiliated Hospital of Sun Yat-sen University
    Zhuhai, Guangdong 519000, China
08

References and documents

Individual participant data

Plan to share: No — Publication of academic papers

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06006611
Lead sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University
Responsible party
Sponsor
First posted
Aug 23, 2023
Start date
Aug 5, 2023
Primary completion
Oct 25, 2023 (estimated)
Completion
Oct 30, 2023 (estimated)
Last update
Sep 21, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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