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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05595031
Other study ID # 044.PHA.2021.D
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 19, 2021
Est. completion date October 19, 2023

Study information

Verified date October 2022
Source Methodist Health System
Contact Crystee Cooper, DHEd
Phone 214-947-1280
Email clinicalresearch@mhd.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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. Glucocorticoids have become standard of care for critical COVID-19 patients, with a mortality benefit shown in several recent randomized control trials. Critical COVID-19 can lead to ARDS, in which the use of glucocorticoids has uncertain benefit beyond 10 days. Studies have shown increased harm in the use of these agents in persistent ARDS (≥14 days). Additionally, studies supporting the use of steroids in COVID-19 only used steroids for a limited time (up to 10 days). Given that these agents can possibly lead to increased patient morbidity and mortality, prolonged use of glucocorticoids is not without risk. To date, there have been no studies evaluating the clinical impact of glucocorticoid use beyond 10 days for treatment of critical COVID-19.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date October 19, 2023
Est. primary completion date October 19, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - > 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause in-hospital mortality at 28 days All-cause in-hospital mortality at 28 days 28 days
Secondary Bacteremia growth of a pathogenic organism in 1 of 4 blood culture sites; blood cultures are considered contaminants if 1 of 4 sets grows a typically non-pathogenic organism or if the clinical team determines the organism a contaminant. To determine if the use of corticosteroids beyond 10 days increases the incidence of secondary infection or impacts duration of MV and length of stay in critical COVID-19. 28 days
Secondary Mechanical ventilator-free days number of days alive and breathing without assistance 28 days
Secondary ICU LOS number of days alive and admitted to the ICU 28 days
Secondary Hospital LOS number of days alive and admitted to MDMC 28 days
Secondary hospital acquired pneumonia (HAP) New lung infiltrate after 48 hrs of admission, positive respiratory culture, AND clinical evidence suggestive of new infection. To determine if the use of corticosteroids beyond 10 days increases the incidence of secondary infection or impacts duration of MV and length of stay in critical COVID-19. 28 days
Secondary ventilator-associated pneumonia (VAP) VAP arises >48 hrs after intubation. To determine if the use of corticosteroids beyond 10 days increases the incidence of secondary infection or impacts duration of MV and length of stay in critical COVID-19. 28 days
Secondary C. diff infection (CDI) Acute onset of diarrhea (> 3 unformed or watery stools occurring in < 24 hours) AND positive test for toxigenic C. difficile or pseudomembranous colitis on endoscopy OR high clinical suspicion. To determine if the use of corticosteroids beyond 10 days increases the incidence of secondary infection or impacts duration of MV and length of stay in critical COVID-19. 28 days
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