Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vanderbilt University Medical Center
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Age ≥ 50 years
2. Hospital admission to ward or ICU (including observation status admissions)
3. Acute pneumonia defined as fulfilling each of the following two criteria: (a) New (\<7-day duration) or worsening symptoms consistent with a lower respiratory tract infection, including ≥ 1 of the following: cough, shortness of breath, chest pain, sputum production, or decline in mental status; (b) Radiographic findings on chest x-ray or CT consistent with acute pulmonary infection, including pulmonary opacities, infiltrates, or pleural effusion.
4. CRP ≥ 15 mg/dL within 24 hours of enrollment
22. Unable to take the enteral study medicine by mouth or tube
23. Prior enrollment in this study at any time
24. Non-English speaking
25. Confirmed or suspected COVID-19 as the cause of the patient's acute illness -
You may not be if
1. Systemic steroid use within the past 30-days.
2. Clinical team planning to treat with systemic steroids during this hospitalization independent of the study protocol.
3. Unable to randomize patient within 24 hours of hospital presentation.
4. Hospital-acquired pneumonia, defined as development of clinical and radiographic signs of pneumonia as an inpatient in an acute care hospital. (Residence in a nursing home or assisted living facility is not an exclusion criterion.)
5. Unable to follow simple commands or non-verbal prior to this acute illness.
6. Pre-existing severe dementia, defined as an Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score ≥ 4.12.
8. Serum sodium \> 145 mEq/L (hypernatremia) or potassium \< 3.5 mEq/L (hypokalemia) at screening and randomization
9. Systolic blood pressure \> 180 mmHg or a diastolic blood pressure \> 100 mmHg at the start and end of screening.
10. Any history of diabetes mellitus, having a serum blood glucose \> 250 mg/dL, or requiring an anti-diabetic medication (e.g., insulin)
11. Previous allergic or adverse reaction to a corticosteroid
12. Severe immunosuppression, defined as any of the following: HIV with CD4 count \< 200 cells/mm3, absolute neutrophil count \< 500 cells/mm3, solid organ or hematopoietic stem cell transplant with in the past 90 days.
13. Cystic fibrosis
14. Active cancer, defined as new diagnosis or treatment for cancer in the past 6 months.
15. Any history of adrenal insufficiency
16. Substance abuse (alcohol, opioid, benzodiazepines, methamphetamines, cocaine) within the past year
17. Any history of hospitalizations due to psychiatric illnesses within the past year
18. Gastro-intestinal bleeding treated with hospital admission and/or blood transfusion within the past 3 months.
19. Pre-existing medical condition resulting in a life expectancy \< 6 months.
20. Clinical team does not believe the patient should enter the study due to concerns about potential steroid-related complications.
