Investigation of Subsequent and Co-infections Associated... | NCT04561193

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

NCT04561193

Sponsor

Methodist Health System

Status

Completed

Last Update Posted

Mar 23, 2026Actual

Enrollment

417Actual

Phase

Not provided

Conditions

COVID-19

Interventions

Observational

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 30, 2020Actual

Primary Completion Date

May 23, 2022Actual

Completion Date

May 23, 2022Actual

First Submitted Date

Sep 22, 2020

First Submission Date that Met QC Criteria

Sep 22, 2020

First Posted Date

Sep 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2026

Last Update Posted Date

Mar 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Multicenter retrospective chart review of patients admitted to any of the four Methodist Health System hospitals

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

417Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other	Observational	Retrospective Cohort

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew Crotty, PharmD	Methodist Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Dallas Medical Center		Dallas	Texas	75203	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided