Clinical trial NCT05595031: Evaluation of the Clinical Impact of Corticosteroid Duration on SARS-CoV-2 (COVID-19 WHO)
Official title: Evaluation of the Clinical Impact of Corticosteroid Duration on SARS-CoV-2 Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid 19
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause in-hospital mortality at 28 days
timeFrame: 28 days
Secondary outcomes:
measure: Bacteremia
timeFrame: 28 days
measure: Mechanical ventilator-free days
timeFrame: 28 days
measure: ICU LOS
timeFrame: 28 days
measure: Hospital LOS
timeFrame: 28 days
measure: hospital acquired pneumonia (HAP)
timeFrame: 28 days
measure: ventilator-associated pneumonia (VAP)
timeFrame: 28 days
measure: C. diff infection (CDI)
timeFrame: 28 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Kristen Rahmanzadeh, PharmD
role: PRINCIPAL_INVESTIGATOR
References: