Clinical trial NCT05815485: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: COVID-19
Keywords: Azeliragon
Acute Kidney Injury
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients with at least two of the following signs or symptoms: cough, chest pain, shortness of breath, hypoxia (oxygen saturation \<90%)
* Clinical diagnosis of pneumonia or COVID-19 during the first 48 hours of hospitalization.
* Patients admitted to the hospital within the previous 48 hours (from time of admission to initial treatment dose.)
* Provide informed consent to participate in the study (by participant or legally-acceptable representative).

Exclusion Criteria:

* Patients for whom intubation within 24 hours of admission is considered likely.
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3x upper limit of normal (ULN), OR total serum bilirubin \>2x ULN.
* Patients who were receiving dialysis as a regular treatment at the time of admission. (Participants are not excluded for historic need for dialysis.)
* Chronic liver disease with Child-Pugh class B of (7 to 9) or higher.
* Patients with an electrocardiogram (ECG) corrected QT interval (QTc) \> 500 ms.
* Patients requiring treatment with strong inhibitors of CYP2C8
* Females of childbearing potential who are pregnant, breastfeeding, and/or not using a highly-effective method of contraception (consistent with local regulations regarding the methods of contraception for those participating in clinical studies, including willingness to use 2 acceptable forms of contraception from screening until after the end of drug treatment. Acceptable forms include tubal ligation, male latex condom with or without spermicide, partner's vasectomy, diaphragm with spermicide, intrauterine device, cervical cap/sponge with spermicide, contraceptive sponge, female condom, hormonal contraceptive including oral, transdermal, vaginal ring, subcutaneous injection, or implanted rod.)
* Allergy to azeliragon or formulation excipients in the azeliragon or placebo capsule.
* Concurrent participation in another device or drug trial for treatment purposes. Trials with devices intended for diagnostic purposes only are allowable..
* Any other condition, including abnormal laboratory values that, in the judgment of the investigator, could put the participant at increased risk, or would interfere with the conduct or planned analysis of the study.

Primary outcomes:
measure: Frequency of Adverse Events (AEs) (Phase 2 only)
timeFrame: Up to 28 days post-treatment
measure: 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)
timeFrame: Day 14 of hospitalization
Secondary outcomes:
measure: Frequency of each AKI Kidney Disease Improving Global Outcomes (KDIGO) scale scores (Phase 3 only)
timeFrame: Day 14 of hospitalization
measure: Frequency of sustained renal function (Phase 3 only)
timeFrame: Day 14 of hospitalization
measure: Frequency of renal function after prior AKI of stage 2 or higher (Phase 3 only)
timeFrame: Day 14 of hospitalization
measure: Frequency of Intensive Care Unit (ICU) admission (Phase 3 only)
timeFrame: Day 14 of hospitalization
measure: Number of days in ICU (Phase 3 only)
timeFrame: Day 14 of hospitalization
measure: Frequency of AEs (Phase 3 only)
timeFrame: Day 14 of hospitalization
measure: Length of hospitalization (Phase 3 only)
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Lucas S. Blanton, MD
role: PRINCIPAL_INVESTIGATOR
References: