A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Determine the Safety and Effectiveness of Azeliragon in the Treatment of Patients Hospitalized for Coronavirus Disease 2019 (COVID-19) or Pneumonia

Browse trials for

• COVID-19 7,640
• Pneumonia 2,044

Keywords

• Azeliragon
• Acute Kidney Injury

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 144 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Lead sponsor

The University of Texas Medical Branch, Galveston is the lead sponsor of 251 studies on the registry; 38 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Study arms

• Experimental
  Phase 2 azeliragon

  Drug: Azeliragon

• Placebo comparator
  Phase 2 placebo

  Drug: Placebo

• Experimental
  Phase 3 azeliragon

  Drug: Azeliragon

• Placebo comparator
  Phase 3 placebo

  Drug: Placebo

Interventions

• DrugAzeliragon

  30 mg twice daily for 5 days followed by 20 mg once daily for 5 days or until discharge (whichever is earliest).

• DrugPlacebo

  Twice daily for 5 days then 1 time daily for 5 days or until discharge (whichever is earliest).

Primary outcomes

1. 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

2. 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

Secondary outcomes

1. 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

2. 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

3. 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

4. Frequency of Intensive Care Unit (ICU) admission (Phase 3 only)

   Time frame: Day 14 of hospitalization

5. Number of days in ICU (Phase 3 only)

   Time frame: Day 14 of hospitalization

6. 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

7. Length of hospitalization (Phase 3 only)

   Time frame: Up to 14 days

Individual participant data

Plan to share: No