Evaluation of the Clinical Impact of Corticosteroid Duration on SARS-CoV-2 (COVID-19 WHO)
- Conditions
- Covid 19
- Registration Number
- NCT05595031
- Lead Sponsor
- Methodist Health System
- 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- > 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause in-hospital mortality at 28 days 28 days All-cause in-hospital mortality at 28 days
- Secondary Outcome Measures
Name Time Method hospital acquired pneumonia (HAP) 28 days 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.
ventilator-associated pneumonia (VAP) 28 days 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.
Mechanical ventilator-free days 28 days number of days alive and breathing without assistance
Hospital LOS 28 days number of days alive and admitted to MDMC
Bacteremia 28 days 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.
ICU LOS 28 days number of days alive and admitted to the ICU
C. diff infection (CDI) 28 days 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.
Trial Locations
- Locations (1)
Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States