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

NCT05815485 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 24-0103HUM00221960
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19

Keywords

Azeliragon; Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Frequency of each AKI Kidney Disease Improving Global Outcomes (KDIGO) scale scores (Phase 3 only)

  Day 14 of hospitalization

• Frequency of sustained renal function (Phase 3 only)

  Day 14 of hospitalization

• Frequency of renal function after prior AKI of stage 2 or higher (Phase 3 only)

  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

Study Arms (4)

Phase 2 azeliragon

EXPERIMENTAL

Drug: Azeliragon

Phase 2 placebo

PLACEBO COMPARATOR

Drug: Placebo

Phase 3 azeliragon

EXPERIMENTAL

Drug: Azeliragon

Phase 3 placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Azeliragon DRUG

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

Phase 2 azeliragon; Phase 3 azeliragon

Placebo DRUG

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

Phase 2 placebo; Phase 3 placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (3)

Rush University

Chicago, Illinois, 60612, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

COVID-19; Acute Kidney Injury

Interventions

azeliragon

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Lucas S. Blanton, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: April 18, 2023
• Study Start: May 4, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)