NCT06006611

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

September 21, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 21, 2023

Last Update Submit

September 19, 2023

Conditions

COVID-19

Keywords

COVID-19Azvudineseverity

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality of COVID-19 patients

    All-cause mortality of COVID-19 patients

    Time from onset to death

Study Arms (3)

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

AzvudineDRUG

Received antiviral treatment with azvudine

Azvudine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The COVID-19 positive patients

You may qualify if:

  • The COVID-19 positive patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

azvudine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 23, 2023

Study Start

August 5, 2023

Primary Completion

October 25, 2023

Study Completion

October 30, 2023

Last Updated

September 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Publication of academic papers

Locations

CN(1)