Evaluation of the Clinical Impact of Corticosteroid Duration on SARS-CoV-2 (COVID-19 WHO)

Covid 19 Clinical Trial

Official title:

Evaluation of the Clinical Impact of Corticosteroid Duration on SARS-CoV-2 Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05595031
• Other study ID #: 044.PHA.2021.D
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Covid 19
• COVID-19

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