Evaluation of the Clinical Impact of Corticosteroid Duration on SARS-CoV-2 (COVID-19 WHO)
1 other identifier
observational
400
1 country
1
Brief Summary
The purpose of this project is to evaluate the clinical impact of the use of glucocorticoids beyond 10 days for patients with critical COVID-19 at MDMC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2021
CompletedFirst Submitted
Initial submission to the registry
May 24, 2022
CompletedFirst Posted
Study publicly available on registry
October 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2023
CompletedOctober 26, 2022
October 1, 2022
2 years
May 24, 2022
October 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
All-cause in-hospital mortality at 28 days
All-cause in-hospital mortality at 28 days
28 days
Secondary Outcomes (7)
Bacteremia
28 days
Mechanical ventilator-free days
28 days
ICU LOS
28 days
Hospital LOS
28 days
hospital acquired pneumonia (HAP)
28 days
- +2 more secondary outcomes
Eligibility Criteria
This is a retrospective chart review study limited to only patients meeting inclusion and exclusion criteria. Determination of the clinical impact of corticosteroid dosing will be aided by a larger cohort of patients. We plan to conduct the retrospective chart review of all patients identified during the study period 08/01/2020 to 01/31/2021 that meet inclusion and exclusion criteria.
You may qualify if:
- \> 18 years of age
- ICU admission at any time during first hospital admission for COVID-19
- COVID-19 diagnosis
- Dexamethasone, hydrocortisone, or methylprednisolone therapy for SARS-CoV-2 infection
You may not qualify if:
- Prior ICU admission before study start date
- Death or hospice before day 11 of hospital admission
- Still admitted at time of data analysis from index admission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Methodist Dallas Medical Center
Dallas, Texas, 75052, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristen Rahmanzadeh, PharmD
The Methodist Hospital Research Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2022
First Posted
October 26, 2022
Study Start
October 19, 2021
Primary Completion
October 19, 2023
Study Completion
October 19, 2023
Last Updated
October 26, 2022
Record last verified: 2022-10