NCT04561193

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
417

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2022

Completed
Last Updated

March 23, 2026

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

September 22, 2020

Last Update Submit

March 19, 2026

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Prevalence of subsequent and co-infections

    Prevalence of subsequent and co-infections

    Feb 2020 - April 2020

Secondary Outcomes (2)

  • In-hospital mortality

    Feb 2020 - April 2020

  • Hospital length of stay (LOS)

    Feb 2020 - April 2020

Study Arms (1)

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

ObservationalOTHER

Observational

Retrospective Cohort

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Matthew Crotty, PharmD

    Methodist Health System

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 22, 2020

First Posted

September 23, 2020

Study Start

May 30, 2020

Primary Completion

May 23, 2022

Study Completion

May 23, 2022

Last Updated

March 23, 2026

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)