NCT06321367

Brief Summary

The goal of this observational study is to learn about the clinical characteristics and construction of a predictive model in elderly COVID-19 patients. The main question it aims to answer is the main clinical characteristics and risk factors of elderly COVID-19 patients. Participants will not be asked to do any other intervening measure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

March 19, 2024

Last Update Submit

March 19, 2024

Conditions

Keywords

COVID-19elderlynomogramcoinfectionsdiagnosis

Outcome Measures

Primary Outcomes (1)

  • Coinfection

    The investigators defined coinfection as coinfected bacteria, fungi, or other viruses with SARS-CoV-2 that occurred from admission to 7 days after admission. If a diagnosis was at the time of or within the first 48 hours of COVID-19 hospital admission, these infections were defined as community-acquired infections. If diagnosis occurred ≥48 hours to 7 days after admission for COVID-19, these infections were defined as early-onset hospital-acquired infections.

    from admission to 7 days after admission

Study Arms (2)

elderly COVID-19 patients with coinfection

elderly COVID-19 without coinfection

Eligibility Criteria

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

Elderly COVID-19 patients admitted into Xiangya Hospital of Central South University (in Changsha, Hunan) and Xiangya Hospital of Central South University, Jiangxi (in Nanchang, Jiangxi)

You may qualify if:

  • Age greater than or equal to 65 years old;
  • COVID-19 was diagnosed with SARS-CoV-2 reverse transcription-polymerase chain reaction positive or rapid antigen test positive or a clinical diagnosis made by the radiological responsible clinician based on signs, symptoms, or radiology consistent with COVID-19;
  • Hospitalization more than one day, including patients in emergency.

You may not qualify if:

  • Age less than 65 years old;
  • Pregnancy;
  • Hospitalization less than one day;
  • Outpatients;
  • Patients with missing or incomplete information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

COVID-19CoinfectionDisease

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 20, 2024

Study Start

December 20, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations