Model to Predict Coinfection in Elderly Patients With COVID-19

March 19, 2024 updated by: Xiangya Hospital of Central South University

Construction and Validation of a Predictive Model of Coinfections in Elderly COVID-19 Patients After Abandoning Zero Policy

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410000
        • Xiangya Hospital of Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability 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)

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
elderly COVID-19 patients with coinfection
elderly COVID-19 without coinfection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coinfection
Time Frame: from admission to 7 days after admission
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202401002
  • 82070613 (Other Grant/Funding Number: the National Natural Sciences Foundation of China)
  • 82370638 (Other Grant/Funding Number: the National Natural Sciences Foundation of China)
  • 2022RC1212 (Other Grant/Funding Number: the Science and Technology Innovation Program of Hunan Province)
  • 2023JJ10095 (Other Grant/Funding Number: he Natural Science Foundation of Hunan Province China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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