NCT04701515

Brief Summary

Electronic medical record review of de-identified patients who tested positive for COVID-19 (using a PCR test) at Methodist Dallas Medical Center (MDMC) from June 2020 until the date of IRB approval. Data will be collected on de-identified patients that test positive for COVID-19 (using a PCR test) at MDMC from the date of IRB approval until December 2022. Disclaimer: Any cost associated with the procedures stated herein will be billed directly to you or to your insurance (as applicable)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 22, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
2.2 years until next milestone

Study Start

First participant enrolled

March 21, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2024

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

September 22, 2020

Last Update Submit

July 11, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (8)

  • Heart failure

    Presence or absence

    March 2020 - June 2021

  • Tamponade

    Presence or absence

    March 2020 - June 2021

  • Pericardial Effusion

    Presence or absence

    March 2020 - June 2021

  • Myocarditis

    Presence or absence

    March 2020 - June 2021

  • Pericarditis

    Presence or absence

    March 2020 - June 2021

  • Arrythmias

    Presence or absence

    March 2020 - June 2021

  • Troponin I

    Level

    March 2020 - June 2021

  • N-terminal prohormone BNP

    Level

    March 2020 - June 2021

Secondary Outcomes (10)

  • Stroke

    March 2020 - June 2021

  • Myocardial infarction

    March 2020 - June 2021

  • Shock

    March 2020 - June 2021

  • Deep venous thrombosis

    March 2020 - June 2021

  • Discharge disposition

    March 2020 - June 2021

  • +5 more secondary outcomes

Study Arms (1)

Retrospective Cohort

Review electronic medical records of de-identified patients that tested positive for COVID-19 (using a PCR test) at Methodist Dallas Medical Center (MDMC) from June 2020 until December 2022

Other: Chart review

Interventions

Chart reviewOTHER

Chart review

Retrospective Cohort

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that test positive for COVID-19 (using a PCR test) at MDMC

You may qualify if:

  • Hospitalized patient
  • Adult over 18 years
  • Positive COVID-19 PCR Test

You may not qualify if:

  • None

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

Condition Hierarchy (Ancestors)

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

Study Officials

  • Manavjot Sidhu, MD

    Methodist Health System

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 22, 2020

First Posted

January 8, 2021

Study Start

March 21, 2023

Primary Completion

May 21, 2024

Study Completion

May 21, 2024

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)