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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid 19

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75052
      • Recruiting
      • Methodist Dallas Medical Center
      • Contact: Zaid Haddadin, MS; Phone Number: 2149471280; Email: clinicalresearch@mhd.com
      • Principal Investigator: Kristen Rahmanzadeh, Pharm D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause in-hospital mortality at 28 days	All-cause in-hospital mortality at 28 days	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mechanical ventilator-free days	number of days alive and breathing without assistance	28 days
ICU LOS	number of days alive and admitted to the ICU	28 days
Hospital LOS	number of days alive and admitted to MDMC	28 days
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
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
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

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Kristen Rahmanzadeh, PharmD, Methodist Dallas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Anticipated): October 19, 2023
• Study Completion (Anticipated): October 19, 2023

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 044.PHA.2021.D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No