Investigation of Subsequent and Co-infections Associated With SARS-CoV-2 (COVID-19)

May 24, 2022 updated by: Methodist Health System
Multicenter retrospective chart review of patients admitted to any of the four Methodist Health System hospitals

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Multicenter retrospective chart review of patients admitted to any of the four Methodist Health System hospitals (Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas) between February 1 and April 30, 2020. All study center utilize Epic ® electronic health record (Verona, Wisconsin; www.epic.com) for which all data will be extracted from.

Study Type

Observational

Enrollment (Actual)

417

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

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Methodist Dallas Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with positive COVID-19 PCR test admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between February 1, 2020 and April 30, 2020.

Description

Inclusion Criteria:

  • Patients admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between February 1, 2020 and April 30, 2020
  • >18 years old
  • Positive SARS-CoV-2 (COVID-19) PCR test

Exclusion Criteria:

  • Outpatient or emergency department visit
  • Not admitted to an inpatient or observation status for >24 hours

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective Cohort
Patients admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between February 1, 2020 and April 30, 2020 with positive COVID-19 PCR test.
Other: Observational
Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of subsequent and co-infections
Time Frame: Feb 2020 - April 2020
Prevalence of subsequent and co-infections
Feb 2020 - April 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: Feb 2020 - April 2020
In-hospital mortality
Feb 2020 - April 2020
Hospital length of stay (LOS)
Time Frame: Feb 2020 - April 2020
Hospital length of stay (LOS)
Feb 2020 - April 2020

Collaborators and Investigators

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

Sponsor

Methodist Health System

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)

May 30, 2020

Primary Completion (Actual)

May 23, 2022

Study Completion (Actual)

May 23, 2022

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (Actual)

September 23, 2020

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 033.PHA.2020.A

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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