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

NCT ID: NCT05815485

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-04
• Study Completion Date: 2026-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Phase 2 azeliragon

Group Type: EXPERIMENTAL

Azeliragon

Intervention Type: 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 placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Phase 3 azeliragon

Group Type: EXPERIMENTAL

Azeliragon

Intervention Type: DRUG

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

Phase 3 placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Azeliragon

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucas S. Blanton, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

Rush University

Chicago, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Texas Medical Branch

Galveston, Texas, United States

Countries

United States

Other Identifiers

HUM00221960

Identifier Type: OTHER

Identifier Source: secondary_id

24-0103

Identifier Type: -

Identifier Source: org_study_id