Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HUM00221960 | Other Identifier | University of Michigan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2 azeliragon | Experimental |
| |
| Phase 2 placebo | Placebo Comparator |
| |
| Phase 3 azeliragon | Experimental |
| |
| Phase 3 placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azeliragon | Drug | 30 mg twice daily for 5 days followed by 20 mg once daily for 5 days or until discharge (whichever is earliest). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Day 14 of hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lucas S. Blanton, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University | Chicago | Illinois | 60612 | United States | ||
| University of Michigan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Azeliragon and placebo will be dispensed and labeled by the unblinded research pharmacist at each site in a blinded manner that will not reveal if the product dispensed is active or placebo.
| Placebo | Drug | Twice daily for 5 days then 1 time daily for 5 days or until discharge (whichever is earliest). |
|
| 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 | Day 14 of hospitalization |
| Frequency of renal function after prior AKI of stage 2 or higher (Phase 3 only) | Serum creatinine levels to < 1.5 times baseline level | Day 14 of hospitalization |
| Frequency of Intensive Care Unit (ICU) admission (Phase 3 only) | Day 14 of hospitalization |
| Number of days in ICU (Phase 3 only) | 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 | Day 14 of hospitalization |
| Length of hospitalization (Phase 3 only) | Up to 14 days |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000655744 | azeliragon |
Not provided
Not provided
Not provided