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

Methodist Health System

Status: Enrolling

Conditions: Covid 19

Study type: Observational

Funder types: Other

Identifiers

NCT05595031

044.PHA.2021.D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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