A new drug called azeliragon could be used to treat patients with COVID-19 or other pneumonia infections but the researchers don't know. In this study, they are learning the effects of azeliragon patients hospitalized for COVID-19 or pneumonia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
30 mg twice daily for 5 days followed by 20 mg once daily for 5 days or until discharge (whichever is earliest).
Twice daily for 5 days then 1 time daily for 5 days or until discharge (whichever is earliest).
Rush University
Chicago, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Texas Medical Branch
Galveston, Texas, United States
Frequency of Adverse Events (AEs) (Phase 2 only)
Including overall, treatment-related, Grade 3 or higher in severity, serious AEs (SAEs), fatal, and those resulting in treatment discontinuation
Time frame: Up to 28 days post-treatment
Death, need for mechanical ventilation or Acute Kidney Injury (AKI) of stage 2 or higher per Kidney Disease Improving Global Outcomes (KDIGO) scale (Phase 3 only)
The primary outcome is a composite endpoint, which is defined as the need for mechanical ventilation, in-hospital death or AKI of stage 2 or higher per KDIGO scale. There are 3 stages in the KDIGO scale with stage 3 being the worst (corresponds to renal failure). KDIGO Scale definitions: Stage 2 - Serum Creatinine 2-2.9 times baseline Stage 3 - Serum Creatinine 3 times baseline or Increase in serum creatinine to ≥4 mg/dL or Initiation of renal replacement therapy
Time frame: Day 14 of hospitalization
Frequency of each AKI Kidney Disease Improving Global Outcomes (KDIGO) scale scores (Phase 3 only)
There are 3 stages in the KDIGO scale with stage 3 being the worst (corresponds to renal failure). Stage 1- serum creatinine 1.5 to 1.9 times baseline OR an increase in serum creatinine ≥ 0.3 mg/dL OR urine output \< 0.5ml/kg/hour for 6-12 hours. Stage 2- serum creatinine 2.0-2.9 times baseline OR urine output \<0.5mg/kg/hour for ≥ 12 hours Stage 3- serum creatinine 3.0 times baseline (or serum creatinine of more than or equal to 4.0 mg/dl with an acute increase of at least 0.5 mg/dl) (OR) Urine output less than 0.3 ml/kg/hour for 24 hours or anuria for 12 hours or new renal replacement therapy
Time frame: Day 14 of hospitalization
Frequency of sustained renal function (Phase 3 only)
Renal function defined by no increase in serum creatinine of ≥0.3mg/dL during any 48hr period, AND no increase in serum creatinine of ≥1.5 times
Time frame: Day 14 of hospitalization
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Frequency of renal function after prior AKI of stage 2 or higher (Phase 3 only)
Serum creatinine levels to \< 1.5 times baseline level
Time frame: Day 14 of hospitalization
Frequency of Intensive Care Unit (ICU) admission (Phase 3 only)
Time frame: Day 14 of hospitalization
Number of days in ICU (Phase 3 only)
Time frame: Day 14 of hospitalization
Frequency of AEs (Phase 3 only)
Including: overall, treatment-related, Grade 3 or higher in severity, serious, fatal, and those resulting in treatment discontinuation
Time frame: Day 14 of hospitalization
Length of hospitalization (Phase 3 only)
Time frame: Up to 14 days